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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This is a two-phase study. Phase 1 will evaluate obesity-related behavioral and biological characteristics as potential predictors of response to behavioral treatment (BT) for weight loss. Phase 2 is a double-blind, placebo-controlled, RCT to test whether adding weight loss medication to BT improves 24-week weight loss, as compared to BT with placebo, in subjects identified as having suboptimal early weight loss after 4 weeks of individual behavioral weight control. All participants, regardless of their early weight loss, will receive the same BT program of diet, physical activity, and behavior therapy for weight loss for an additional 24 weeks (28 total weeks of treatment).
Subjects will be a total of 150 adults, aged 21-70 years, with a body mass index (BMI) of 31 kg/m2 or above (28 kg/m2 with an obesity-related comorbidity). In phase 1, eligible subjects will complete questionnaires and an in-person baseline assessment of obesity-related behavioral characteristics (satiety, hunger, the relative reinforcing value of food [RRVfood], and impulsivity [delay discounting]), neuropeptides, and gastric emptying. After this baseline assessment, participants will begin an initial 4-week behavioral treatment (BT) "run-in" delivered individually in 20-30 minute weekly sessions (delivered virtually).
The primary goal of phase 1 will be to evaluate baseline satiety, postprandial change in GLP-1, and gastric emptying as predictors of percent weight loss after 4 weeks of BT. We will also examine whether these variables predict categorization as a suboptimal early responder to BT (e.g., <2.0% loss; co-primary outcome).
Secondary endpoints of phase 1 are percent weight loss from the start of the BT run-in (week -4) to randomization (week 0) and categorization as a suboptimal early responder, as predicted by additional behavioral characteristics (hunger as measured by VAS ratings, RRVfood as measured using a computer task, and impulsivity as measured using a delay discounting computer task) and neuropeptides (higher fasting ghrelin, lower fasting leptin, and lower postprandial changes in insulin and PYY).
In phase 2, suboptimal early responders (based on weight loss during the BT run-in) will be randomly assigned to 24 weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg). Both treatment groups will continue to attend 20-30 minute individual BT sessions (delivered virtually), weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits). Both treatment groups will also take once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period. Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
The assessments administered at baseline - questionnaires, including behavioral testing, blood draws, and measurements of body weight - will be repeated at randomization (week 0) and at week 24.
The primary endpoint of phase 2 is change in body weight (i.e., % reduction in initial weight), as measured from randomization to week 24, among suboptimal early responders assigned to BT+P vs. BT+M. A randomized sample size of 50 non-responders (25 per group), assuming a 20% attrition rate, will give us 81.5% power to detect between-treatment group differences at week 24 of 4.5% (effect size: d = 0.82).
Secondary endpoints of phase 2 will include change in body weight in kg from randomization to week 24, as well as the portion of suboptimal early responders who achieve a post-randomization loss of ≥ 5% and ≥ 10% of initial body weight. We will also examine differences between suboptimal early responders treated with BT+M vs. BT+P in changes in hunger, satiety, the reinforcing efficacy of food, and impulsivity between randomization and week 24. A comparison will also be made in percent weight loss from randomization to week 24 between suboptimal early responders treated with BT+M and early responders treated with BT alone.
If you are interested in participating in this study, information and a link to contact the research team can be found here: https://clinicalresearch.itmat.upenn.edu/3XOX/ or you can call us at the numbers listed below.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 2: Behavioral Treatment + Placebo | Active Comparator | Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period. Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial. |
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| Phase 2: Behavioral Treatment + Medication | Active Comparator | Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period. Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial. |
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| Phase 1: 4-week Behavioral Treatment Run-in | Other | All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss <2% of initial weight after 4 weeks of BT. Early responders are those who lose >=2%. Only early non-responders will then be enrolled in the randomized trial. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Treatment | Behavioral | Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits). |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Percent Weight Loss | Co-primary outcomes - phase 1 | Week -4 (start of BT run-in) to week 0 (randomization) |
| Phase 1: Number of Participants Who Are Categorized as Early Non-responders at Randomization (Week 0), Based on Percent Weight Loss | Co-primary outcomes - phase 1 | Week -4 (start of BT run-in) to week 0 (randomization) |
| Phase 1: Baseline Satiety, as Measured by Visual Analogue Scales (Range 0-100 mm) During a Test Meal; Satiety Quotient = [(Post-preload Rating - Fasting Rating Before Preload)] / (Energy Content of Preload in kcal) x 100. | Primary predictor variable - phase 1 Appetite suppression was first calculated as the average of 100 mm VAS items: hunger (reverse score), satisfaction, fullness, and prospective consumption (reverse score), such that higher scores indicate more appetite suppression (less appetite) for each test meal rating (fasting, then every 10m for 60m). The satiety quotient was then calculated for each post-preload rating using the above formula (see measure title). More positive scores show increased satiety (more appetite suppression). The final analysis uses the 60-minute area under the curve (AUC) for the satiety quotient to predict phase 1 weight loss outcomes. Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min*(x(i) + x(i-1))/2) where x is the satiety quotient value at time i. Higher scores indicate higher sustained satiety. | Baseline (week -5) |
| Phase 1: Baseline Postprandial Change in GLP-1 During a Test Meal | Primary predictor variable - phase 1. Blood samples were drawn at time 0 (fasting) and 30- and 60-min postprandial samples after consumption of a test meal. Value presented below is the 60-minute incremental area under the curve (AUC) for GLP-1 in picomoles (pM). Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr*(x(i) + x(i-1))/2) where x is the GLP-1 value in pM at time i. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Baseline Hunger, as Measured by Visual Analogue Scales (Range 0-100 mm, Higher = More Hunger) During a Test Meal | Secondary predictor variable - phase 1 Hunger was rated before and at 10 min intervals after a test meal for 60 min. Data presented below are the 60-min area under the curve (AUC) for postprandial change in hunger at baseline.(more negative = more sustained reduction in hunger). Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min*(x(i) + x(i-1))/2) where x is the hunger scale score at time i. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Baseline Eating Behavior as Measured by The Eating Inventory (EI); Dietary Restraint Subscale (Scored 0-21 Higher=More Restraint), Disinhibition Sub Scale (Scored 0-16 Higher=More Disinhibition), Hunger Sub Scale (Scored 0-14 Higher=More Hunger) | Exploratory predictor variable - phase 1 The Eating Inventory (EI); Dietary restraint subscale (scored 0-21 higher=more restraint), Disinhibition sub scale (scored 0-16 higher=more disinhibition), Hunger sub scale (scored 0-14 higher=more hunger) |
Inclusion Criteria:
BMI ≥ 31 kg/m² (or 28 kg/m2 with obesity-related comorbidity)
Age ≥ 21 years and ≤ 70 years
Eligible female patients will be:
Subjects must:
Exclusion Criteria:
Other Therapy: Subjects will be expected to use medications (prescribed by their PCP) to control traditional cardiometabolic risk factors (e.g., hypertension, hypercholesterolemia, etc) and other co-morbid conditions, with the exception of medications listed above under "exclusions." In all cases, the subjects' PCP will be asked at the study's outset to keep medication does constant throughout the study, whenever possible. Subjects will be expected to have been on their medication regimen (including the dose) for 3 months prior to beginning the BT program.
To be eligible to participate in the randomized phase of the trial, subjects must also:
Early BT responders who lose>=2% during the BT run-in will be offered the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
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| Name | Affiliation | Role |
|---|---|---|
| Jena S Tronieri, PhD | Perelman School of Medicine at the University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Center for Weight and Eating Disorders | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40055520 | Derived | Tronieri JS, Ghanbari E, Chevinsky J, LaFata EM, Minnick AM, Rajpal S, Wang SY, Burcaw K, Berkowitz RI, Wadden TA. Anti-obesity medication for weight loss in early nonresponders to behavioral treatment: a randomized controlled trial. Nat Med. 2025 May;31(5):1653-1660. doi: 10.1038/s41591-025-03556-3. Epub 2025 Mar 7. |
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147 pts consented & enrolled in phase 1. Of those, 16 did not enroll in phase 2: 7 did not complete >=3 BT sessions, 5 could not complete a randomization visit due to COVID-19, 3 were lost to follow-up and 1 declined.
55 pts were early responders. For clinical purposes, these pts continued to receive BT for 24 weeks but because they were not eligible for randomization they were not part of the RCT.
76 pts were early non-responders (4-week weight loss < 2%) randomized to BT+ placebo or BT+ med
Recruitment occurred from July 2019 to November 2021. No participants could be enrolled between March 15, 2020 and July 1, 2020 due to COVID-19.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1 (4-week Non-randomized BT run-in) | The 147 participants that initially enrolled received 4 weeks of BT. |
| FG001 | Phase 2: Behavioral Treatment + Placebo | Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period. Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial. Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits). Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill. |
| FG002 | Phase 2: Behavioral Treatment + Medication | Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period. Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial. Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits). Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: 4-week Non-randomized BT run-in |
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| Phase 2: Randomized Trial |
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Baseline characteristics at the start of Phase 1 for all enrolled participants. Only 76 participants were identified as early non-responders and enrolled in the randomized trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: 4-week Behavioral Treatment Run-in | All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss <2% of initial weight after 4 weeks of BT. Early responders are those who lose >=2%. Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits). Note: Data represent the baseline characteristics of all enrolled participants at the start of phase 1 (week -4). Only 76 participants were later eligible to enroll in the randomized trial. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase 1: Percent Weight Loss | Co-primary outcomes - phase 1 | Percent weight loss at the end of the 4-week BT run-in (phase 1) for all 134 individuals who provided a weight measurement at the end of the run-in (week 0) and for the subset of 76 individuals who were categorized as early non-responders and then enrolled in the randomized trial (phase 2) | Posted | Mean | Standard Deviation | % change in weight | Week -4 (start of BT run-in) to week 0 (randomization) |
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Time period: 4-week BT-run-in and 24-week randomized trial Adverse events are reported for all 147 participants during phase 1 (4-week run-in) and in phase 2 for the 76 participants who were identified as early non-responders and were randomly assigned to BT + phentermine or BT + placebo and the 55 early responders. Event frequencies for early responders cannot be compared directly to those of early non-responders because events were not queried systematically in the responder group.
For randomized participants, side effects were queried during each study visit. Subjects also were instructed to contact study staff if they experience any AE between study visits. AEs were not queried systematically for non-randomized early responders but were tracked if reported to staff. The study physician or NP determined the severity of each AE and its possible relation to treatment using standard criteria, and the appropriate course of action for the study subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1: 4-week BT run-in | Adverse events occurring prior to randomization in the 147 participants who consented and enrolled in Phase 1 of the trial. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jena Tronieri | University of Pennsylvania | 2157465045 | jena.tronieri@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2021 | May 7, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D001070 | Appetitive Behavior |
| D000855 | Anorexia |
| D015431 | Weight Loss |
| D001835 | Body Weight |
| D001836 | Body Weight Changes |
| D012816 | Signs and Symptoms |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D004304 | Dosage Forms |
| D010645 | Phentermine |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
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Phase 1 is observational. Phase 2 is a double-blind, placebo-controlled, randomized controlled trial.
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Double-blind
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| Placebo | Drug | The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill. |
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| Phentermine 15 MG | Drug | The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill. |
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| Baseline |
| Phase 1: Baseline Gastric Emptying During a Test Meal (Acetaminophen Test) | Primary predictor variable - phase 1 Gastric emptying was measured as the 60-minute area under the curve (AUC) for acetaminophen in micrograms per milliliter (ug/mL). Blood samples were obtained at time 0 (fasting/no acetaminophen - confirmatory) and 30 and 60-min after ingestion. Because acetaminophen is minimally absorbed by the stomach but quickly enters the bloodstream in the small intestine, gastric emptying is considered to be the primary factor influencing its appearance in the blood. Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr*(x(i) + x(i-1))/2) where x is the acetaminophen value in ug/mL at time i. | Baseline |
| Phase 2: Percent Weight Loss | Primary outcomes - phase 2 Percent change from randomization in body weight | Week 0 (randomization) to week 24 |
| Baseline |
| Phase 1: Baseline Relative Reinforcing Value of Food (Computer Task), Number of Food Reinforcer Points Earned | Secondary predictor variable - phase 1 Subjects are allowed to work to earn points from a slot machine task at either of two computer stations, one of which provides points towards obtaining a serving of a preferred high-calorie food, and the other points towards a preferred low-calorie food. Points are earned on a progressive ratio scale that increases at fixed intervals. The primary outcome is the number of reinforcer points (servings) earned for the high energy density food, which is thought to reflect the subject's willingness to allocate time and effort to obtaining desired high-calorie foods. The minimum number of points that can be earned is 0; there is no specified maximum. | Baseline |
| Phase 1: Baseline Delay Discounting (Computer Task), Area Under the Curve Representing the Ratio of Immediate Reward Size to Time Delay | Secondary predictor variable - phase 1 Delay discounting is assessed via a computer program in which subjects are offered choices between small, immediate monetary rewards and larger, delayed rewards. The present delay discounting computer task used 7 time delays for $1000. The outcome is the area under the curve (AUC) representing the ratio of immediate reward size to time delay. AUCs were standardized to fall between 0 and 1 (Myerson et al., 2001) and were calculated for the plot of subjective values vs. delay, with lower values indicating greater discounting. Area under the curve is calculated using the trapezoidal rule to sum the area under each standardized time interval. AUC = Σ i = 0 to i = 1 proportion of max delay*(x(i) + x(i-1))/2) where x is the proportion of the maximum price inflection value at time i. | Baseline |
| Phase 1: Baseline Implicit Wanting, Reaction Time on Leeds Food Preference Questionnaire | Secondary predictor variable - phase 1 Implicit wanting is measured by the Leeds Food Preference Questionnaire, a computer-based task using a forced choice paradigm for four categories: High-fat savory, high-fat sweet, low-fat savory, low-fat sweet. Reaction times are transformed to a standardized D-score that is then adjusted for the frequency of selection using a validated algorithm. Scores can range from -100 to 100 with more positive scores indicating a more rapid preference for one category over the other and more negative scores indicating the opposite. | Baseline |
| Phase 1: Baseline Fasting Ghrelin | Secondary predictor variable - phase 1 Blood samples were drawn at time 0 (fasting). Active ghrelin. Unit: Picograms per milliliter (pg/mL) | Baseline |
| Phase 1: Baseline Fasting Leptin | Secondary predictor variable - phase 1 Unit: Picograms per milliliter (pg/mL) Blood samples were drawn at time 0 (fasting). | Baseline |
| Phase 1: Baseline Postprandial Change in Insulin During a Test Meal | Secondary predictor variable - phase 1 Blood samples were drawn at time 0 (fasting) and 30- and 60-min postprandial samples after consumption of a test meal. Incremental area under the curve in insulin measured in micro-international units per milliliter (ulU/mL). Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr*(x(i) + x(i-1))/2) where x is the insulin value in ulU/mL at time i. | Baseline |
| Phase 1: Baseline Postprandial Change in Peptide YY During a Test Meal | Secondary predictor variable - phase 1 Blood samples were drawn at time 0 (fasting) and 30- and 60-min postprandial samples after consumption of a test meal. Value presented below is the 60-minute incremental area under the curve (AUC) for PYY in picograms per milliliter (pgmL) at baseline. Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr*(x(i) + x(i-1))/2) where x is the PYY value in pg/mL at time i. | Baseline |
| Phase 2: Weight Loss (kg) | Secondary outcomes - phase 2 | Week 0 (randomization) to week 24 |
| Phase 2: Number of Participants With a Weight Loss of 5% or Greater of Randomization Body Weight at Week 24 | Secondary outcomes - phase 2 | Week 0 (randomization) to week 24 |
| Phase 2: Number of Participants With a Weight Loss of 10% or Greater of Randomization Body Weight at Week 24 | Secondary outcomes - phase 2 | Week 0 (randomization) to week 24 |
| Phase 2: Change in Appetite Suppression, as Measured by Visual Analogue Scales (Range 0-100 mm) During a Test Meal | Secondary outcomes - phase 2 Appetite suppression was first calculated as the average of 100 mm VAS items: hunger (reverse score), satisfaction, fullness, and prospective consumption (reverse score), such that higher scores indicate more appetite suppression (less appetite) for each test meal rating (fasting, then every 10m for 60m). The final analysis uses the 60-minute incremental area under the curve (AUC) for change in appetite suppression from fasting. Higher scores indicate higher sustained appetite suppression. Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min*(x(i) + x(i-1))/2) where x is the appetite suppression value at time i. | Week 0 (randomization) to week 24 |
| Phase 2: Change in Hunger, as Measured by Visual Analogue Scales (Range 0-100 mm, Higher=More Hunger) During a Test Meal | Secondary outcomes - phase 2 Hunger was rated before and at 10 min intervals after a test meal for 60 min. Data presented below are the 60-min incremental area under the curve (AUC) for postprandial change in hunger at randomization and week 24. More negative scores indicate greater sustained reductions in hunger from fasting. Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min*(x(i) + x(i-1))/2) where x is the scale score at time i. | Week 0 (randomization) to week 24 |
| Phase 2: Change in Delay Discounting (Computer Task), Area Under the Curve Representing the Ratio of Immediate Reward Size to Time Delay | Secondary outcomes - phase 2 Delay discounting is assessed via a computer program in which subjects are offered choices between small, immediate monetary rewards and larger, delayed rewards. The present delay discounting computer task used 7 time delays for $1000. The outcome is the area under the curve (AUC) representing the ratio of immediate reward size to time delay. AUCs were standardized to fall between 0 and 1 (Myerson et al., 2001) and were calculated for the plot of subjective values vs. delay, with lower values indicating greater discounting. Area under the curve is calculated using the trapezoidal rule to sum the area under each standardized time interval. AUC = Σ i = 0 to i = 1 proportion of max delay*(x(i) + x(i-1))/2) where x is the proportion of the maximum price inflection value at time i. | Week 0 (randomization) to week 24 |
| Baseline |
| Phase 1: Baseline Appetite Ratings (Ratings of Appetite During the Past Week Using Visual Analogue Scales, Scored 0-100 mm, Higher=Greater Amount or Frequency) | Exploratory predictor variable - phase 1 Appetite was rated weekly using the Control of Eating Questionnaire. Participants were asked to rate items based on their appetite in the past week. For the present analysis, "appetite" was calculated as the mean of the ratings for hunger, fullness after meals (reversed), and thoughts about wanting food. Higher scores (Range 0 - 100) indicate greater past-week appetite. | Baseline |
| Phase 1: Baseline Reinforcing Value of Food as Measured by the Power of Food Scale | Exploratory predictor variable - phase 1 Power of Food Scale (PFS; range 1-5, higher=greater power of food) | Baseline |
| Phase 1: Baseline Sensitivity to Reward as Measured by the Behavioral Inhibition/Activation Scale (BIS/BAS) | Exploratory predictor variable - phase 1 BIS subscale range 7-28, higher = greater inhibition; BAS reward responsiveness sub scale range 5-20, higher=greater reward responsiveness | Baseline |
| Phase 1: Baseline Impulsivity as Measured by The Barratt Impulsiveness Scale | Exploratory predictor variable - phase 1 BIS-15, range 15-60, higher= more impulsiveness | Baseline |
| Phase 1: Baseline Binge Eating as Measured by The Questionnaire on Eating and Weight Patterns (QEWP-5); Measure Categorizes Participants Based on Whether They May Meet Diagnostic Criteria for Binge Eating Disorder | The potential presence or absence of binge eating disorder (BED) is determined based on the participant's responses to questions assessing DSM-5 criteria for the disorder. Participants are categorized as potentially having BED, potentially having subthreshold BED (meets all criteria except frequency) or unlikely to have BED based on questionnaire responses. Exploratory predictor variable - phase 1. | Baseline |
| Phase 1: Baseline Craving Frequency as Measured by the Food Craving Q Trait - Reduced | Exploratory predictor variable - phase 1 The Food Craving Q Trait - Reduced, total score (sum of 15 items, range 15-90); higher scores indicate more food cravings | Baseline |
| Phase 1: Baseline Emotional Eating as Measured by the Dutch Eating Behaviour Questionnaire (DEBQ) | Exploratory predictor variable - phase 1 The Dutch Eating Behaviour Questionnaire (DEBQ) Emotional Eating subscale, mean of 13 items, range 1-5, higher scores indicate more emotional eating | Baseline |
| Phase 1: Baseline Perceived Barriers to Healthy Eating and Physical Activity (Scale by Welsh et al., 2012) | Exploratory predictor variable - phase 1 Data presented are for the total score taken as the sum of all 40 items, range 40-200. Higher total scores indicate more perceived barriers. | Baseline |
| Phase 1: Baseline Weight Efficacy Life-Style Questionnaire (WEL) | Exploratory predictor variable - phase 1 Weight Efficacy Life-Style Questionnaire (WEL), sum of 8 items, range 0-80, higher scores indicate greater weight-related self-efficacy | Baseline |
| Phase 1: Baseline SCI Exercise Self Efficacy Scale (ESES) | Exploratory predictor variable - phase 1 SCI Exercise Self Efficacy Scale (ESES) total score, sum of 10 items, range 10-40, higher scores indicate greater exercise-related self-efficacy | Baseline |
| Phase 1: Randomization Ball and Crawford Social Support Scale | Exploratory predictor variable - phase 1 Four subscales: positive social support for eating, negative social support for eating, positive social support for exercise, and negative social support for exercise were scored separately for family and for friends. Participants rated these individuals support during the 4-week BT run-in. Participants were instructed not to answer items if not applicable. Each subscale has a range of 1-5 with higher scores indicating more positive/negative social support. | Randomization (week 0) |
| Phase 1: Baseline Food Addiction Using the Yale Food Addiction Scale (YFAS) | Exploratory predictor variable - phase 1 The YFAS symptom count (continuous outcome) total score was used for the present data, symptom score range 0-11, higher scores indicate more food addiction symptoms | Baseline |
| Phase 1: The Reinforcing Efficacy of High- and Low-calorie Food | Exploratory predictor variable - phase 1 Questionnaire version of the relative reinforcing value of food computer task in which participants were asked how many servings of a preferred snack food they would consume in 1 week if they had access to no other snack foods for that week and could not stockpile for a later date. They complete this question at different price levels of the food and the reported score is the elasticity of demand which is the slope of the relationship between price (log) and number of servings that the person would purchase. Scores typically range between 0 and -2, though lower scores are theoretically possible. More negative values indicate larger reductions in purchasing of the snack food for each increase in price. | Baseline |
| Phase 1: Baseline Sleep Hours Survey | Exploratory predictor variable - phase 1 Average hours slept per night, including weekday and weekend nights, potential range 0 - 24, higher scores indicate more sleep | Baseline |
| Phase 1: Baseline Perceived Stress Scale | Exploratory predictor variable - phase 1 Total score on the Perceived Stress Scale, sum of 10 items, range 0-40, higher scores indicate more perceived stress | Baseline |
| Phase 1: Baseline Anxiety as Measured by the GAD-7 | Exploratory predictor variable - phase 1 Anxiety as measured by the GAD-7, sum of 7 items, range 0-28, higher scores indicate more anxiety | Baseline |
| Phase 1: Baseline General Mindfulness and Acceptance as Measured Using the Philadelphia Mindfulness Scale | Exploratory predictor variable - phase 1 Two separate subscales were scored: mindful awareness and acceptance, range 1-5 for both subscales. Higher scores indicate more awareness or acceptance. | Baseline |
| Phase 2: Change in Blood Pressure (Systolic) | Exploratory outcomes - phase 2. Systolic blood pressure | Week 0 (randomization) to week 24 |
| Phase 2: Change in Pulse | Exploratory outcomes - phase 2. Pulse | Week 0 (randomization) to week 24 |
| Phase 2: Change in Triglycerides | Exploratory outcomes - phase 2 | Week 0 (randomization) to week 24 |
| Phase 2: Change in HDL and LDL Cholesterol | Exploratory outcomes - phase 2. Reported here is HDL | Week 0 (randomization) to week 24 |
| Phase 2: Change in Fasting Blood Sugar | Exploratory outcomes - phase 2. Fasting glucose. | Week 0 (randomization) to week 24 |
| Phase 2: Change in Appetite Ratings (Ratings of Appetite During the Past Week Using Visual Analogue Scales, Scored 0-100 mm) | Exploratory outcomes - phase 2 Appetite was rated weekly using the Control of Eating Questionnaire. Participants were asked to rate items based on their appetite in the past week. For the present analysis, "appetite" was calculated as the mean of the ratings for hunger, fullness after meals (reversed), and thoughts about wanting food. Higher scores (Range 0 - 100) indicate greater past-week appetite. | Week 0 (randomization) to week 24 |
| Phase 2: Change in Weight-related Quality of Life as Measured by the Impact of Weight on Quality of Life (IWQOL) | Exploratory outcomes - phase 2 Impact of Weight on Quality of Life (IWQOL) scale scores are transformed to a t-score ranging from 0-100 (e.g., 50 indicates the population mean with a standard deviation of 10). Higher t-scores are better. Positive values below for change in this measure represent improvement from randomization to week 24. | Week 0 (randomization) to week 24 |
| Phase 2: Change in Depressive Symptoms as Measured by the Patient Health Questionnaire (PHQ-9) | Exploratory outcomes - phase 2 Sum of 9 items, possible range 0-27. Lower scores are better (less depression). Negative values below for change in this measure represent improvement from randomization to week 24. | Week 0 (randomization) to week 24 |
| Phase 2: Change in Physical Activity Using the Paffenbarger Physical Activity Questionnaire | Exploratory outcomes - phase 2 Outcome from this measure is activity minutes per week. Potential range 0 - 10,080 min/week. Higher scores indicate more minutes of activity per week. Positive values below for change in this measure represent improvement from randomization to week 24. | Week 0 (randomization) to week 24 |
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| OG001 | Behavioral Treatment + Placebo | All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period. Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial. Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits). Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill. |
| OG002 | Behavioral Treatment + Medication | All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period. Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial. Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits). Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill. |
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| Primary | Phase 1: Number of Participants Who Are Categorized as Early Non-responders at Randomization (Week 0), Based on Percent Weight Loss | Co-primary outcomes - phase 1 | 16 were not enrolled in Phase 2: 7 did not complete at least 3 BT sessions 5 could not complete a randomization visit due to COVID-19 3 were lost to follow-up 1 declined randomization | Posted | Count of Participants | Participants | Week -4 (start of BT run-in) to week 0 (randomization) |
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| Primary | Phase 1: Baseline Satiety, as Measured by Visual Analogue Scales (Range 0-100 mm) During a Test Meal; Satiety Quotient = [(Post-preload Rating - Fasting Rating Before Preload)] / (Energy Content of Preload in kcal) x 100. | Primary predictor variable - phase 1 Appetite suppression was first calculated as the average of 100 mm VAS items: hunger (reverse score), satisfaction, fullness, and prospective consumption (reverse score), such that higher scores indicate more appetite suppression (less appetite) for each test meal rating (fasting, then every 10m for 60m). The satiety quotient was then calculated for each post-preload rating using the above formula (see measure title). More positive scores show increased satiety (more appetite suppression). The final analysis uses the 60-minute area under the curve (AUC) for the satiety quotient to predict phase 1 weight loss outcomes. Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min*(x(i) + x(i-1))/2) where x is the satiety quotient value at time i. Higher scores indicate higher sustained satiety. | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). Additional missing data were attributable to participants whose VAS responses at baseline were not complete enough to be scored. | Posted | Mean | Standard Deviation | Satiety quotient*min | Baseline (week -5) |
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| Primary | Phase 1: Baseline Postprandial Change in GLP-1 During a Test Meal | Primary predictor variable - phase 1. Blood samples were drawn at time 0 (fasting) and 30- and 60-min postprandial samples after consumption of a test meal. Value presented below is the 60-minute incremental area under the curve (AUC) for GLP-1 in picomoles (pM). Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr*(x(i) + x(i-1))/2) where x is the GLP-1 value in pM at time i. | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 14 participants for whom we could not obtain at least one postprandial blood sample and/or a fasting blood sample. | Posted | Mean | Standard Deviation | pM*hr | Baseline |
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| Primary | Phase 1: Baseline Gastric Emptying During a Test Meal (Acetaminophen Test) | Primary predictor variable - phase 1 Gastric emptying was measured as the 60-minute area under the curve (AUC) for acetaminophen in micrograms per milliliter (ug/mL). Blood samples were obtained at time 0 (fasting/no acetaminophen - confirmatory) and 30 and 60-min after ingestion. Because acetaminophen is minimally absorbed by the stomach but quickly enters the bloodstream in the small intestine, gastric emptying is considered to be the primary factor influencing its appearance in the blood. Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr*(x(i) + x(i-1))/2) where x is the acetaminophen value in ug/mL at time i. | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 13 participants for whom we could not obtain at least one postprandial blood sample. | Posted | Mean | Standard Deviation | ug/mL*hr | Baseline |
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| Primary | Phase 2: Percent Weight Loss | Primary outcomes - phase 2 Percent change from randomization in body weight | Posted | Mean | Standard Error | % change in weight | Week 0 (randomization) to week 24 |
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| Secondary | Phase 1: Baseline Hunger, as Measured by Visual Analogue Scales (Range 0-100 mm, Higher = More Hunger) During a Test Meal | Secondary predictor variable - phase 1 Hunger was rated before and at 10 min intervals after a test meal for 60 min. Data presented below are the 60-min area under the curve (AUC) for postprandial change in hunger at baseline.(more negative = more sustained reduction in hunger). Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min*(x(i) + x(i-1))/2) where x is the hunger scale score at time i. | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). | Posted | Mean | Standard Deviation | score on a scale*min | Baseline |
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| Secondary | Phase 1: Baseline Relative Reinforcing Value of Food (Computer Task), Number of Food Reinforcer Points Earned | Secondary predictor variable - phase 1 Subjects are allowed to work to earn points from a slot machine task at either of two computer stations, one of which provides points towards obtaining a serving of a preferred high-calorie food, and the other points towards a preferred low-calorie food. Points are earned on a progressive ratio scale that increases at fixed intervals. The primary outcome is the number of reinforcer points (servings) earned for the high energy density food, which is thought to reflect the subject's willingness to allocate time and effort to obtaining desired high-calorie foods. The minimum number of points that can be earned is 0; there is no specified maximum. | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). An additional 5 participants had missing data for this task at baseline. | Posted | Mean | Standard Deviation | Points (portions) earned | Baseline |
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| Secondary | Phase 1: Baseline Delay Discounting (Computer Task), Area Under the Curve Representing the Ratio of Immediate Reward Size to Time Delay | Secondary predictor variable - phase 1 Delay discounting is assessed via a computer program in which subjects are offered choices between small, immediate monetary rewards and larger, delayed rewards. The present delay discounting computer task used 7 time delays for $1000. The outcome is the area under the curve (AUC) representing the ratio of immediate reward size to time delay. AUCs were standardized to fall between 0 and 1 (Myerson et al., 2001) and were calculated for the plot of subjective values vs. delay, with lower values indicating greater discounting. Area under the curve is calculated using the trapezoidal rule to sum the area under each standardized time interval. AUC = Σ i = 0 to i = 1 proportion of max delay*(x(i) + x(i-1))/2) where x is the proportion of the maximum price inflection value at time i. | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). | Posted | Mean | Standard Deviation | dollar*day | Baseline |
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| Secondary | Phase 1: Baseline Implicit Wanting, Reaction Time on Leeds Food Preference Questionnaire | Secondary predictor variable - phase 1 Implicit wanting is measured by the Leeds Food Preference Questionnaire, a computer-based task using a forced choice paradigm for four categories: High-fat savory, high-fat sweet, low-fat savory, low-fat sweet. Reaction times are transformed to a standardized D-score that is then adjusted for the frequency of selection using a validated algorithm. Scores can range from -100 to 100 with more positive scores indicating a more rapid preference for one category over the other and more negative scores indicating the opposite. | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 2 participants due to their not completing the LFPQ at their baseline assessment | Posted | Mean | Standard Deviation | Scale score | Baseline |
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| Secondary | Phase 1: Baseline Fasting Ghrelin | Secondary predictor variable - phase 1 Blood samples were drawn at time 0 (fasting). Active ghrelin. Unit: Picograms per milliliter (pg/mL) | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 14 participants for whom we could not obtain a fasting blood sample or for whom fasting ghrelin results were out of range. | Posted | Mean | Standard Deviation | pg/mL | Baseline |
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| Secondary | Phase 1: Baseline Fasting Leptin | Secondary predictor variable - phase 1 Unit: Picograms per milliliter (pg/mL) Blood samples were drawn at time 0 (fasting). | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 10 participants for whom we could not obtain a fasting blood sample or whose sample results were out of range. | Posted | Mean | Standard Deviation | pg/mL | Baseline |
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| Secondary | Phase 1: Baseline Postprandial Change in Insulin During a Test Meal | Secondary predictor variable - phase 1 Blood samples were drawn at time 0 (fasting) and 30- and 60-min postprandial samples after consumption of a test meal. Incremental area under the curve in insulin measured in micro-international units per milliliter (ulU/mL). Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr*(x(i) + x(i-1))/2) where x is the insulin value in ulU/mL at time i. | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 14 participants for whom we could not obtain at least one postprandial blood sample and/or a fasting blood sample. | Posted | Mean | Standard Deviation | ulU/mL*hr | Baseline |
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| Secondary | Phase 1: Baseline Postprandial Change in Peptide YY During a Test Meal | Secondary predictor variable - phase 1 Blood samples were drawn at time 0 (fasting) and 30- and 60-min postprandial samples after consumption of a test meal. Value presented below is the 60-minute incremental area under the curve (AUC) for PYY in picograms per milliliter (pgmL) at baseline. Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr*(x(i) + x(i-1))/2) where x is the PYY value in pg/mL at time i. | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 14 participants for whom we could not obtain at least one postprandial blood sample and/or a fasting blood sample. | Posted | Mean | Standard Deviation | pg/mL*hr | Baseline |
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| Secondary | Phase 2: Weight Loss (kg) | Secondary outcomes - phase 2 | Posted | Mean | Standard Error | kg | Week 0 (randomization) to week 24 |
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| Secondary | Phase 2: Number of Participants With a Weight Loss of 5% or Greater of Randomization Body Weight at Week 24 | Secondary outcomes - phase 2 | Posted | Count of Participants | Participants | Week 0 (randomization) to week 24 |
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| Secondary | Phase 2: Number of Participants With a Weight Loss of 10% or Greater of Randomization Body Weight at Week 24 | Secondary outcomes - phase 2 | Posted | Count of Participants | Participants | Week 0 (randomization) to week 24 |
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| Secondary | Phase 2: Change in Appetite Suppression, as Measured by Visual Analogue Scales (Range 0-100 mm) During a Test Meal | Secondary outcomes - phase 2 Appetite suppression was first calculated as the average of 100 mm VAS items: hunger (reverse score), satisfaction, fullness, and prospective consumption (reverse score), such that higher scores indicate more appetite suppression (less appetite) for each test meal rating (fasting, then every 10m for 60m). The final analysis uses the 60-minute incremental area under the curve (AUC) for change in appetite suppression from fasting. Higher scores indicate higher sustained appetite suppression. Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min*(x(i) + x(i-1))/2) where x is the appetite suppression value at time i. | Randomized participants who completed the study (N = 71 of 76) and also completed the appetite test meal assessment at week 24 (N = 63 of 71). An additional two placebo-treated participants provided appetite ratings, but incremental area under the curve could not be calculated due to missing fasting item data. | Posted | Mean | Standard Deviation | mm*min | Week 0 (randomization) to week 24 |
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| Secondary | Phase 2: Change in Hunger, as Measured by Visual Analogue Scales (Range 0-100 mm, Higher=More Hunger) During a Test Meal | Secondary outcomes - phase 2 Hunger was rated before and at 10 min intervals after a test meal for 60 min. Data presented below are the 60-min incremental area under the curve (AUC) for postprandial change in hunger at randomization and week 24. More negative scores indicate greater sustained reductions in hunger from fasting. Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min*(x(i) + x(i-1))/2) where x is the scale score at time i. | Randomized participants who completed the study (N = 71 of 76) and also completed the appetite test meal assessment at week 24 (N = 63 of 71). An additional two placebo-treated participants provided appetite ratings, but incremental area under the curve could not be calculated due to missing fasting item data. | Posted | Mean | Standard Deviation | mm*min | Week 0 (randomization) to week 24 |
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| Secondary | Phase 2: Change in Delay Discounting (Computer Task), Area Under the Curve Representing the Ratio of Immediate Reward Size to Time Delay | Secondary outcomes - phase 2 Delay discounting is assessed via a computer program in which subjects are offered choices between small, immediate monetary rewards and larger, delayed rewards. The present delay discounting computer task used 7 time delays for $1000. The outcome is the area under the curve (AUC) representing the ratio of immediate reward size to time delay. AUCs were standardized to fall between 0 and 1 (Myerson et al., 2001) and were calculated for the plot of subjective values vs. delay, with lower values indicating greater discounting. Area under the curve is calculated using the trapezoidal rule to sum the area under each standardized time interval. AUC = Σ i = 0 to i = 1 proportion of max delay*(x(i) + x(i-1))/2) where x is the proportion of the maximum price inflection value at time i. | Randomized participants who completed the study (N = 71 of 76) and also completed the delay discounting assessment at week 24 (N = 63 of 71). | Posted | Mean | Standard Deviation | dollar*day | Week 0 (randomization) to week 24 |
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| Other Pre-specified | Phase 1: Baseline Eating Behavior as Measured by The Eating Inventory (EI); Dietary Restraint Subscale (Scored 0-21 Higher=More Restraint), Disinhibition Sub Scale (Scored 0-16 Higher=More Disinhibition), Hunger Sub Scale (Scored 0-14 Higher=More Hunger) | Exploratory predictor variable - phase 1 The Eating Inventory (EI); Dietary restraint subscale (scored 0-21 higher=more restraint), Disinhibition sub scale (scored 0-16 higher=more disinhibition), Hunger sub scale (scored 0-14 higher=more hunger) | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). Eating Inventory scores for an additional 4 participants could not be calculated due to missing items | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Other Pre-specified | Phase 1: Baseline Appetite Ratings (Ratings of Appetite During the Past Week Using Visual Analogue Scales, Scored 0-100 mm, Higher=Greater Amount or Frequency) | Exploratory predictor variable - phase 1 Appetite was rated weekly using the Control of Eating Questionnaire. Participants were asked to rate items based on their appetite in the past week. For the present analysis, "appetite" was calculated as the mean of the ratings for hunger, fullness after meals (reversed), and thoughts about wanting food. Higher scores (Range 0 - 100) indicate greater past-week appetite. | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). | Posted | Mean | Standard Deviation | mm | Baseline |
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| Other Pre-specified | Phase 1: Baseline Reinforcing Value of Food as Measured by the Power of Food Scale | Exploratory predictor variable - phase 1 Power of Food Scale (PFS; range 1-5, higher=greater power of food) | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 6 participants due to missing items on the scale | Posted | Mean | Standard Deviation | Scale score | Baseline |
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| Other Pre-specified | Phase 1: Baseline Sensitivity to Reward as Measured by the Behavioral Inhibition/Activation Scale (BIS/BAS) | Exploratory predictor variable - phase 1 BIS subscale range 7-28, higher = greater inhibition; BAS reward responsiveness sub scale range 5-20, higher=greater reward responsiveness | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 5 participants due to missing items on the BIS-BAS scale | Posted | Mean | Standard Deviation | Scale score | Baseline |
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| Other Pre-specified | Phase 1: Baseline Impulsivity as Measured by The Barratt Impulsiveness Scale | Exploratory predictor variable - phase 1 BIS-15, range 15-60, higher= more impulsiveness | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the BIS-15 scale | Posted | Mean | Standard Deviation | Scale score | Baseline |
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| Other Pre-specified | Phase 1: Baseline Binge Eating as Measured by The Questionnaire on Eating and Weight Patterns (QEWP-5); Measure Categorizes Participants Based on Whether They May Meet Diagnostic Criteria for Binge Eating Disorder | The potential presence or absence of binge eating disorder (BED) is determined based on the participant's responses to questions assessing DSM-5 criteria for the disorder. Participants are categorized as potentially having BED, potentially having subthreshold BED (meets all criteria except frequency) or unlikely to have BED based on questionnaire responses. Exploratory predictor variable - phase 1. | Posted | Count of Participants | Participants | Baseline |
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| Other Pre-specified | Phase 1: Baseline Craving Frequency as Measured by the Food Craving Q Trait - Reduced | Exploratory predictor variable - phase 1 The Food Craving Q Trait - Reduced, total score (sum of 15 items, range 15-90); higher scores indicate more food cravings | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the scale | Posted | Mean | Standard Deviation | Scale score | Baseline |
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| Other Pre-specified | Phase 1: Baseline Emotional Eating as Measured by the Dutch Eating Behaviour Questionnaire (DEBQ) | Exploratory predictor variable - phase 1 The Dutch Eating Behaviour Questionnaire (DEBQ) Emotional Eating subscale, mean of 13 items, range 1-5, higher scores indicate more emotional eating | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the scale | Posted | Mean | Standard Deviation | Scale score | Baseline |
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| Other Pre-specified | Phase 1: Baseline Perceived Barriers to Healthy Eating and Physical Activity (Scale by Welsh et al., 2012) | Exploratory predictor variable - phase 1 Data presented are for the total score taken as the sum of all 40 items, range 40-200. Higher total scores indicate more perceived barriers. | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 4 participants due to missing items on the scale | Posted | Mean | Standard Deviation | Scale score | Baseline |
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| Other Pre-specified | Phase 1: Baseline Weight Efficacy Life-Style Questionnaire (WEL) | Exploratory predictor variable - phase 1 Weight Efficacy Life-Style Questionnaire (WEL), sum of 8 items, range 0-80, higher scores indicate greater weight-related self-efficacy | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the scale | Posted | Mean | Standard Deviation | Scale score | Baseline |
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| Other Pre-specified | Phase 1: Baseline SCI Exercise Self Efficacy Scale (ESES) | Exploratory predictor variable - phase 1 SCI Exercise Self Efficacy Scale (ESES) total score, sum of 10 items, range 10-40, higher scores indicate greater exercise-related self-efficacy | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the scale | Posted | Mean | Standard Deviation | Scale score | Baseline |
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| Other Pre-specified | Phase 1: Randomization Ball and Crawford Social Support Scale | Exploratory predictor variable - phase 1 Four subscales: positive social support for eating, negative social support for eating, positive social support for exercise, and negative social support for exercise were scored separately for family and for friends. Participants rated these individuals support during the 4-week BT run-in. Participants were instructed not to answer items if not applicable. Each subscale has a range of 1-5 with higher scores indicating more positive/negative social support. | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). Participants were instructed not to answer items if not applicable to their household/lifestyle, resulting in fewer ppts completing this scale. | Posted | Mean | Standard Deviation | score on a scale | Randomization (week 0) |
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| Other Pre-specified | Phase 1: Baseline Food Addiction Using the Yale Food Addiction Scale (YFAS) | Exploratory predictor variable - phase 1 The YFAS symptom count (continuous outcome) total score was used for the present data, symptom score range 0-11, higher scores indicate more food addiction symptoms | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). Additional missing data were attributable to missing item responses | Posted | Mean | Standard Deviation | Symptom count | Baseline |
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| Other Pre-specified | Phase 1: The Reinforcing Efficacy of High- and Low-calorie Food | Exploratory predictor variable - phase 1 Questionnaire version of the relative reinforcing value of food computer task in which participants were asked how many servings of a preferred snack food they would consume in 1 week if they had access to no other snack foods for that week and could not stockpile for a later date. They complete this question at different price levels of the food and the reported score is the elasticity of demand which is the slope of the relationship between price (log) and number of servings that the person would purchase. Scores typically range between 0 and -2, though lower scores are theoretically possible. More negative values indicate larger reductions in purchasing of the snack food for each increase in price. | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 9 participants due to missing items on the scale | Posted | Mean | Standard Deviation | (log)dollar/purchased serving | Baseline |
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| Other Pre-specified | Phase 1: Baseline Sleep Hours Survey | Exploratory predictor variable - phase 1 Average hours slept per night, including weekday and weekend nights, potential range 0 - 24, higher scores indicate more sleep | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the scale | Posted | Mean | Standard Deviation | hours slept per night | Baseline |
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| Other Pre-specified | Phase 1: Baseline Perceived Stress Scale | Exploratory predictor variable - phase 1 Total score on the Perceived Stress Scale, sum of 10 items, range 0-40, higher scores indicate more perceived stress | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the scale | Posted | Mean | Standard Deviation | Scale score | Baseline |
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| Other Pre-specified | Phase 1: Baseline Anxiety as Measured by the GAD-7 | Exploratory predictor variable - phase 1 Anxiety as measured by the GAD-7, sum of 7 items, range 0-28, higher scores indicate more anxiety | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 4 participants due to missing items on the scale | Posted | Mean | Standard Deviation | Scale score | Baseline |
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| Other Pre-specified | Phase 1: Baseline General Mindfulness and Acceptance as Measured Using the Philadelphia Mindfulness Scale | Exploratory predictor variable - phase 1 Two separate subscales were scored: mindful awareness and acceptance, range 1-5 for both subscales. Higher scores indicate more awareness or acceptance. | mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the scale | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Other Pre-specified | Phase 2: Change in Blood Pressure (Systolic) | Exploratory outcomes - phase 2. Systolic blood pressure | Posted | Mean | Standard Error | mm Hg | Week 0 (randomization) to week 24 |
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| Other Pre-specified | Phase 2: Change in Pulse | Exploratory outcomes - phase 2. Pulse | Posted | Mean | Standard Error | BPM | Week 0 (randomization) to week 24 |
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| Other Pre-specified | Phase 2: Change in Triglycerides | Exploratory outcomes - phase 2 | Posted | Mean | Standard Error | mg/dL | Week 0 (randomization) to week 24 |
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| Other Pre-specified | Phase 2: Change in HDL and LDL Cholesterol | Exploratory outcomes - phase 2. Reported here is HDL | Posted | Mean | Standard Error | mg/dL | Week 0 (randomization) to week 24 |
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| Other Pre-specified | Phase 2: Change in Fasting Blood Sugar | Exploratory outcomes - phase 2. Fasting glucose. | Posted | Mean | Standard Error | mg/dL | Week 0 (randomization) to week 24 |
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| Other Pre-specified | Phase 2: Change in Appetite Ratings (Ratings of Appetite During the Past Week Using Visual Analogue Scales, Scored 0-100 mm) | Exploratory outcomes - phase 2 Appetite was rated weekly using the Control of Eating Questionnaire. Participants were asked to rate items based on their appetite in the past week. For the present analysis, "appetite" was calculated as the mean of the ratings for hunger, fullness after meals (reversed), and thoughts about wanting food. Higher scores (Range 0 - 100) indicate greater past-week appetite. | Randomized participants who completed the study (N = 71 of 76) and also completed the COEQ at week 24 (N = 65). | Posted | Mean | Standard Deviation | mm | Week 0 (randomization) to week 24 |
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| Other Pre-specified | Phase 2: Change in Weight-related Quality of Life as Measured by the Impact of Weight on Quality of Life (IWQOL) | Exploratory outcomes - phase 2 Impact of Weight on Quality of Life (IWQOL) scale scores are transformed to a t-score ranging from 0-100 (e.g., 50 indicates the population mean with a standard deviation of 10). Higher t-scores are better. Positive values below for change in this measure represent improvement from randomization to week 24. | Posted | Mean | Standard Error | t score | Week 0 (randomization) to week 24 |
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| Other Pre-specified | Phase 2: Change in Depressive Symptoms as Measured by the Patient Health Questionnaire (PHQ-9) | Exploratory outcomes - phase 2 Sum of 9 items, possible range 0-27. Lower scores are better (less depression). Negative values below for change in this measure represent improvement from randomization to week 24. | Posted | Mean | Standard Error | units on a scale | Week 0 (randomization) to week 24 |
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| Other Pre-specified | Phase 2: Change in Physical Activity Using the Paffenbarger Physical Activity Questionnaire | Exploratory outcomes - phase 2 Outcome from this measure is activity minutes per week. Potential range 0 - 10,080 min/week. Higher scores indicate more minutes of activity per week. Positive values below for change in this measure represent improvement from randomization to week 24. | Posted | Mean | Standard Error | minutes per week | Week 0 (randomization) to week 24 |
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| 0 |
| 147 |
| 0 |
| 147 |
| 23 |
| 147 |
| EG001 | Behavioral Treatment + Placebo | All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period. Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial. Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits). Placebo: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill. | 0 | 38 | 0 | 38 | 27 | 38 |
| EG002 | Behavioral Treatment + Medication | All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period. Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial. Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits). Phentermine 15 MG: The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill. | 0 | 38 | 0 | 38 | 23 | 38 |
| EG003 | Early Responders (Behavioral Treatment Alone) | Early responders who lost >2% during the BT run-in continued to receive behavioral treatment alone for 24 more weeks and were not assigned to receive study medication. They were not considered part of the randomized trial and adverse events were not assessed systematically, so frequencies cannot be compared directly to the randomized groups. | 0 | 55 | 0 | 55 | 20 | 55 |
| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| COVID-19 infection | Infections and infestations | Systematic Assessment |
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| Ear infection | Infections and infestations | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Musculoskeletal Injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Sinus infection | Infections and infestations | Systematic Assessment |
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| Upper respiratory infection | Infections and infestations | Systematic Assessment |
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| Reaction to COVID-19 vaccine | General disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Difficulty sleeping | Psychiatric disorders | Systematic Assessment |
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| Dry mouth | General disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D012817 | Signs and Symptoms, Digestive |
| D008919 | Investigative Techniques |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Implicit wanting of low-fat sweet |
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Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included taughter in the same analysis, so separate correlations were conducted. |
| Regression, Linear |
| .72 |
| r |
| -.03 |
| 2-Sided |
| Other |
Correlation to Implicit wanting of Low Fat Savory. |
| Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included together in the same analysis, so separate correlations were conducted. | Regression, Linear | .94 | r | 0.01 | 2-Sided | Other | Correlation to Implicit wanting of High Fat Sweet. |
| Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included together in the same analysis, so separate correlations were conducted. | Regression, Linear | .09 | r | -0.15 | 2-Sided | Other | Correlation to Implicit wanting of Low Fat Sweet. |
| Title | Measurements |
|---|---|
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| negative exercise support from family |
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