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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR002539 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The overall objective of this study is to evaluate the efficacy of a mindfulness-based intervention to prevent weight regain in weight-reduced adults.
Specific Aim 1: Determine the effect of MORE on weight loss maintenance.
Hypothesis:
MORE will result in less weight regain compared to CON after the 8-week intervention, and benefits will be sustained after 6-month of follow-up.
Specific Aim 2:
Determine the effect of MORE on reward-related behavioral processes (e.g., disinhibition, restraint, hedonic hunger).
Hypothesis:
MORE group will demonstrate changes in eating behaviors associated with preventing weight regain compared to CON immediately after MORE and after 6-months of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Orientated Recovery Enhancement (MORE) Intervention | Experimental | 8-week MORE intervention adapted for preventing weight regain |
|
| Control Intervention | Active Comparator | 8-week control intervention based on the Diabetes Prevention Program's Prevent T2 for Life program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Orientated Recovery Enhancement | Behavioral | The MORE curriculum has been adapted for this intervention to address food intake behaviors and will provide training in mindfulness techniques to increase awareness of, and self-control over, cravings; reappraisal skills to promote emotion regulation and restructure motivations for highly palatable food intake; and savoring pleasant events and emotions to overcome defects in natural reward processing. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Body Weight | Body weight (kg) measured using a calibrated digital scale at three time points: baseline and 6 month follow up. Outcome measure was calculated by subtracting baseline weight from 6 month weigh. Lower value indicates greater weight loss. | Baseline and 6 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Ways of Savoring Checklist (WOSC). | Four questions from Bryant and Veroffs Ways of Savoring Checklist (WOSC) were used to assess momentary sensory-perceptual sharpening (ex 'I tried to intensify the moment by focusing on it') and intensifying positive emotional reactions to positive events as 'amplifying' savoring (ex. 'In the last week, I enjoyed the little things in life more fully'). The instrument uses a 5-point Likert scale (ranging from 0 = Strongly Disagree to 5 = Strongly Agree). Scale Range: 4-20 Higher scores on the WOSC indicate a stronger perceived ability to savor positive experiences. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tanya Halliday | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84112 | United States |
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Seven participants were withdrawn before assignment: 2 ineligible, 2 scheduling conflicts, 1 COVID exposure, 1 family tragedy, 1 unknown reason.
Participants were recruited via physician referral at the University of Utah Weight Management Program, electronic health record referrals, and general weight loss maintenance advertisement flyers posted throughout Salt Lake City, Utah. Recruitment explicitly stated the intervention being a mindfulness approach for promoting weight loss maintenance. Interested individuals were invited to complete an online screening form through REDCap.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness Orientated Recovery Enhancement (MORE) Intervention | 8-week MORE intervention adapted for preventing weight regain Mindfulness Orientated Recovery Enhancement: The MORE curriculum has been adapted for this intervention to address food intake behaviors and will provide training in mindfulness techniques to increase awareness of, and self-control over, cravings; reappraisal skills to promote emotion regulation and restructure motivations for highly palatable food intake; and savoring pleasant events and emotions to overcome defects in natural reward processing. |
| FG001 | Control Intervention | 8-week control intervention based on the Diabetes Prevention Program's Prevent T2 for Life program. Control Intervention: The curriculum will be based on the Diabetes Prevention Program's Prevent T2 for Life program, which is an evidence-based national healthful lifestyle maintenance intervention. This program includes training in healthful eating, meal planning, and recipe modification; time and stress management; adapting lifestyle habits for continued success during holidays, vacations, and other special situations; and relapse prevention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness Orientated Recovery Enhancement (MORE) Intervention | 8-week MORE intervention adapted for preventing weight regain Mindfulness Orientated Recovery Enhancement: The MORE curriculum has been adapted for this intervention to address food intake behaviors and will provide training in mindfulness techniques to increase awareness of, and self-control over, cravings; reappraisal skills to promote emotion regulation and restructure motivations for highly palatable food intake; and savoring pleasant events and emotions to overcome defects in natural reward processing. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Changes in Body Weight | Body weight (kg) measured using a calibrated digital scale at three time points: baseline and 6 month follow up. Outcome measure was calculated by subtracting baseline weight from 6 month weigh. Lower value indicates greater weight loss. | Posted | Mean | Standard Deviation | kilograms | Baseline and 6 month follow up |
|
From enrollment through end of participant follow-up (6 months)
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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 | Mindfulness Orientated Recovery Enhancement (MORE) Intervention | 8-week MORE intervention adapted for preventing weight regain Mindfulness Orientated Recovery Enhancement: The MORE curriculum has been adapted for this intervention to address food intake behaviors and will provide training in mindfulness techniques to increase awareness of, and self-control over, cravings; reappraisal skills to promote emotion regulation and restructure motivations for highly palatable food intake; and savoring pleasant events and emotions to overcome defects in natural reward processing. |
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This was a pilot and feasibility trial with a relatively small and non-diverse sample. We included patients who had experienced weight loss via diet/exercise, medication, and bariatric surgery. Due to the quasi-experimental design, we were not able to randomize based on weight loss modality which resulted in a severely skewed sample with most patients who reported to be on weight loss medications to be allocated to the BWI comparison group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tanya Halliday, PhD, RD | University of Utah | 801-213-1364 | tanya.halliday@utah.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 | Jun 29, 2023 | Jul 8, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 29, 2023 | Jul 8, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D015430 | Weight Gain |
| D005247 | Feeding Behavior |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
|
| Control Intervention | Behavioral | The curriculum will be based on the Diabetes Prevention Program's Prevent T2 for Life program, which is an evidence-based national healthful lifestyle maintenance intervention. This program includes training in healthful eating, meal planning, and recipe modification; time and stress management; adapting lifestyle habits for continued success during holidays, vacations, and other special situations; and relapse prevention. |
|
| 6-month follow-up |
| Dietary Restraint | Participants completed the Three-Factor Eating Questionnaire (TFEQ) in a fasted state to measure dietary restraint (conscious restriction of food intake to prevent weight gain or to promote weight loss), disinhibition (tendency to eat opportunistically), and hunger. This questionnaire consists of 20 questions about restraint. Each item is scored either 0 or 1; therefore, the range is 0-20, with higher scores indicating greater levels of dietary restraint. | 6 month follow up |
| Dietary Disinhibition | Participants completed the Three-Factor Eating Questionnaire (TFEQ) in a fasted state to measure dietary restraint (conscious restriction of food intake to prevent weight gain or to promote weight loss), disinhibition (tendency to eat opportunistically), and hunger. This questionnaire consists of 16 items about disinhibition. Each item is scored either 0 or 1; therefore, the range is 0-16, with higher levels indicating greater levels of dietary disinhibition. | 6 month follow-up |
| Interoceptive Awareness | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a self-report instrument utilizing a 6-point Likert scale (ranging from 0 = Never to 5 = Always). Scale Range: 0-55 Higher scores on the MAIA indicate higher ability of interoceptive bodily awareness. | 6 month follow up |
| Hedonic Hunger | Participants completed the Three-Factor Eating Questionnaire (TFEQ) in a fasted state to measure dietary restraint (conscious restriction of food intake to prevent weight gain or to promote weight loss), disinhibition (tendency to eat opportunistically), and hunger. This questionnaire consists of 15 items about general levels of hunger. Each item is scored either 0 or 1; therefore, the range is 0-15, with higher scores indicating greater levels of hedonic hunger. | 6 months |
| Lost to Follow-up |
|
| Pregnancy |
|
| Discovered not eligible - recent cancer diagnosis |
|
| BG001 | Control Intervention | 8-week control intervention based on the Diabetes Prevention Program's Prevent T2 for Life program. Control Intervention: The curriculum will be based on the Diabetes Prevention Program's Prevent T2 for Life program, which is an evidence-based national healthful lifestyle maintenance intervention. This program includes training in healthful eating, meal planning, and recipe modification; time and stress management; adapting lifestyle habits for continued success during holidays, vacations, and other special situations; and relapse prevention. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Weight | Mean | Standard Deviation | kilogram |
|
| EATS-26 | Eating Attitudes Test-26 to evaluate risk for eating disorder. Scale Range: 0 to 78 A higher score indicates greater risk for an eating disorder. Specifically, scores >20 are considered to be the cut off to indicate a participant is at risk for an eating disorder. The EAT-26 combines 3 subscales: 1) Dieting; 2) Bulimia and Food Preoccupation; and 3) Oral Control. Subscales are added together to form the total score typically reported, and reported herein. | Mean | Standard Deviation | units on a scale |
|
| Alcohol Use Disorders Identification Test (AUDIT) | Alcohol Use Disorders Identification Test (AUDIT). Scale Range: 0-40 A score of 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder). | Mean | Standard Deviation | units on a scale |
|
| PHQ-9 | Patient Health Questionnaire (PHQ-9) to determine depression severity. Scale Range: 0-27 Scores of 0-4: Minimal depression. 5-9: Mild depression. 10-14: Moderate depression. 15-19: Moderately severe depression. 20-27: Severe depression | Mean | Standard Deviation | units on a scale |
|
| OG001 | Control Intervention | 8-week control intervention based on the Diabetes Prevention Program's Prevent T2 for Life program. Control Intervention: The curriculum will be based on the Diabetes Prevention Program's Prevent T2 for Life program, which is an evidence-based national healthful lifestyle maintenance intervention. This program includes training in healthful eating, meal planning, and recipe modification; time and stress management; adapting lifestyle habits for continued success during holidays, vacations, and other special situations; and relapse prevention. |
|
|
|
| Secondary | Ways of Savoring Checklist (WOSC). | Four questions from Bryant and Veroffs Ways of Savoring Checklist (WOSC) were used to assess momentary sensory-perceptual sharpening (ex 'I tried to intensify the moment by focusing on it') and intensifying positive emotional reactions to positive events as 'amplifying' savoring (ex. 'In the last week, I enjoyed the little things in life more fully'). The instrument uses a 5-point Likert scale (ranging from 0 = Strongly Disagree to 5 = Strongly Agree). Scale Range: 4-20 Higher scores on the WOSC indicate a stronger perceived ability to savor positive experiences. | Posted | Mean | Standard Error | score on a scale | 6-month follow-up |
|
|
|
|
| Secondary | Dietary Restraint | Participants completed the Three-Factor Eating Questionnaire (TFEQ) in a fasted state to measure dietary restraint (conscious restriction of food intake to prevent weight gain or to promote weight loss), disinhibition (tendency to eat opportunistically), and hunger. This questionnaire consists of 20 questions about restraint. Each item is scored either 0 or 1; therefore, the range is 0-20, with higher scores indicating greater levels of dietary restraint. | Posted | Mean | Standard Error | score on a scale | 6 month follow up |
|
|
|
|
| Secondary | Dietary Disinhibition | Participants completed the Three-Factor Eating Questionnaire (TFEQ) in a fasted state to measure dietary restraint (conscious restriction of food intake to prevent weight gain or to promote weight loss), disinhibition (tendency to eat opportunistically), and hunger. This questionnaire consists of 16 items about disinhibition. Each item is scored either 0 or 1; therefore, the range is 0-16, with higher levels indicating greater levels of dietary disinhibition. | Posted | Mean | Standard Error | score on a scale | 6 month follow-up |
|
|
|
| Secondary | Interoceptive Awareness | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a self-report instrument utilizing a 6-point Likert scale (ranging from 0 = Never to 5 = Always). Scale Range: 0-55 Higher scores on the MAIA indicate higher ability of interoceptive bodily awareness. | Posted | Mean | Standard Error | score on a scale | 6 month follow up |
|
|
|
|
| Secondary | Hedonic Hunger | Participants completed the Three-Factor Eating Questionnaire (TFEQ) in a fasted state to measure dietary restraint (conscious restriction of food intake to prevent weight gain or to promote weight loss), disinhibition (tendency to eat opportunistically), and hunger. This questionnaire consists of 15 items about general levels of hunger. Each item is scored either 0 or 1; therefore, the range is 0-15, with higher scores indicating greater levels of hedonic hunger. | Posted | Mean | Standard Error | score on a scale | 6 months |
|
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Control Intervention | 8-week control intervention based on the Diabetes Prevention Program's Prevent T2 for Life program. Control Intervention: The curriculum will be based on the Diabetes Prevention Program's Prevent T2 for Life program, which is an evidence-based national healthful lifestyle maintenance intervention. This program includes training in healthful eating, meal planning, and recipe modification; time and stress management; adapting lifestyle habits for continued success during holidays, vacations, and other special situations; and relapse prevention. | 0 | 22 | 0 | 22 | 0 | 22 |
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| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |