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| Name | Class |
|---|---|
| Rush University | OTHER |
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The goal of this clinical trial is to test the effectiveness of remotely-delivered interventions (utilizing acceptance-based behavioral treatment skills (ABTi)) amongst bariatric surgery populations who are experiencing weight regain postoperatively (> 5% from their lowest postoperative weight and after postoperative Month 6). Investigators aim to evaluate ABTi's efficacy for reversing weight regain and its effect on targeted weight control behaviors and weight-related comorbidities by comparing participants randomly assigned ABTi (n = 100) to those assigned to a Control group that also receives brief phone calls but that focus on reiterating instruction on the dietary and behavioral changes required of surgery and initially taught preoperatively (C, n = 100).
The main research aims are:
The current study will evaluate a remotely-delivered acceptance-based behavioral intervention (ABTi) for individuals who are experiencing weight regain after bariatric surgery (> 5% from their lowest postoperative weight and after postoperative Month 6). ABTi will be delivered online via interactive modules followed by brief phone calls with health coaches to reinforce the lessons over the course of 6 months. We aim to evaluate ABTi's efficacy for reversing weight regain and its effect on targeted weight control behaviors and weight related comorbidities by comparing participants randomly assigned ABTi (n = 100) to those assigned to a Control group that also receives brief phone calls but that focus on reiterating instruction on the dietary and behavioral changes required of surgery and initially taught preoperatively (C, n = 100). Assessments will be conducted at baseline, and 3, 6 (end of active treatment), and 12 months after enrollment. Seven-day, smartphone-based, Ecological Momentary Assessment (EMA) will be used at each period to precisely measure how aversive internal states drive maladaptive eating patterns that contribute to weight regain and how ABT works to interrupt these patterns to reverse risk and restore a healthy pattern of eating. The study has two primary aims and an exploratory aim.
Aim 1: To compare changes in body weight over 12 months in 200 bariatric patients who have regained > 5% of their weight and are randomly assigned to ABTi or C. (The study is powered on this outcome.) Hypothesis: Participants who receive ABTi will achieve greater reductions in weight at 12 months as compared to those who receive C.
Aim 2: To compare changes in eating behaviors (i.e., caloric intake, frequency of maladaptive eating behaviors), physical activity, and weight-related comorbidities (i.e., biomarkers of diabetes, hypertension) over 12 months in the two groups. Hypothesis: Participants who receive ABTi will report lower caloric intake, greater reductions in maladaptive eating behaviors, greater increases in physical activity, and demonstrate more favorable improvements in weight-related comorbidities than those who receive C.
Aim 3 (Exploratory): To test ABTi's theoretical mechanisms of action, including a) effects of theory-based active ingredients (i.e., acceptance, defusion, values clarity, mindfulness) on weight outcomes and b) changes in impact of internal states (i.e., hunger, cravings) on eating behavior. Hypotheses: a) Changes in ABT variables from baseline to mid-treatment will mediate differences in weight outcomes between conditions from midtreatment to post-treatment; b) The association between eating behavior and subjective states (i.e., hunger, cravings) will weaken in ABTi compared to C from baseline to post-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acceptance-Based Behavioral Intervention | Experimental | Participants assigned to ABTi will receive a remotely delivered intervention consisting of 20 modules over 6 months. Based on theory derived from acceptance and mindfulness approaches, the intervention provides psychological strategies to facilitate engagement in weight control behaviors. Each module includes a video presentation of material synchronized with a slideshow illustrating session material, interactive features, quizzes that will ensure participants have mastered the material, and directed assignments to be completed throughout the week. Participants will be assigned to view each module, self-monitor their daily food intake, and weigh themselves weekly. At the completion of each module, a brief call with a coach will be scheduled to discuss and clarify the content of the session, review homework, and provide feedback on food records and weekly weights. |
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| Control | No Intervention | Participants assigned to the Control condition will receive telephone contacts from the coaches on the same schedule as those who receive ABTi. The content will focus on the (re) delivery of the dietary and behavioral instruction that patients received prior to bariatric surgery. For example, participants will be reminded to consume reduced portion sizes, avoid foods higher in sugar and fat, and eat discrete meals throughout the day. They will receive a Wi-Fi scale and will be asked to weigh themselves weekly, similar to those receiving ABTi. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance-Based Behavioral Intervention | Behavioral | Intervention will evaluate acceptance-based behavioral treatment (ABT) for individuals who are experiencing weight regain after bariatric surgery. ABT builds acceptance and mindfulness skills that increase the capacity to experience uncomfortable internal states (e.g., food cravings, hunger, negative affect). Online treatments include video modules demonstrating session content as well as interactive features. These interventions are particularly desirable, reduced participant burden, and are cost effective. ABT provides patients unique skills that directly target causes of dietary non-adherence. ABT provides patients specialized skills to directly target causes of dietary nonadherence (rather that solely repeating behavioral strategies they received during preoperative medical weight management required by their third party payers and bariatric surgery programs). |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Weight will be measured with a digital scale with participants dressed in light clothes and without shoes. Percent weight loss will be calculated from participants' current weight (at each assessment point) as compared to their baseline weight. Weight will be measured in lbs. | 12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month) |
| Measure | Description | Time Frame |
|---|---|---|
| Caloric Intake | Caloric intake will be measured via the Automated Self Administered 24-hour Dietary Assessment Tool (ASA-24), which is a public-access, freely available (through the National Cancer Institute), web-based tool to obtain high-quality dietary intake data with minimal bias. | 12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month) |
| Measure | Description | Time Frame |
|---|---|---|
| Mechanisms of Action (Exploratory) - Acceptance of food-related internal experiences | Proposed mediators of treatment outcome will be assessed via self-report questionnaires. Acceptance of food-related internal experiences will be measured with the Food-Related Acceptance and Action Questionnaire (FAAQ). The FAAQ is made up of 10 items that are each rated on a seven-point Likert scale (i.e., 1=never true and 7=always true). The minimum score on this scale is a 10 and the maximum score on this scale is a 70. Higher scores generally indicate greater acceptance of motivations to eat. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David B Sarwer, PhD | Contact | 215-707-8632 | dsarwer@temple.edu | |
| Sarah R Fischbach, MPH | Contact | 215-707-8633 | sarah.fischbach@temple.edu |
| Name | Affiliation | Role |
|---|---|---|
| David B Sarwer, PhD | Temple University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University | Recruiting | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32487284 | Background | Hales CM, Carroll MD, Fryar CD, Ogden CL. Prevalence of Obesity and Severe Obesity Among Adults: United States, 2017-2018. NCHS Data Brief. 2020 Feb;(360):1-8. | |
| 14711062 | Background | Bray GA. Risks of obesity. Endocrinol Metab Clin North Am. 2003 Dec;32(4):787-804, viii. doi: 10.1016/s0889-8529(03)00067-7. |
| Label | URL |
|---|---|
| The Valued Living Questionnaire: Defining and measuring valued action within a behavioral framework | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 18, 2024 | Jul 9, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Eating Behavior - Cognitive Constraint | Eating Behavior will be measured via The Eating Inventory, which measures three factors related to eating behavior: 1) cognitive restraint, 2) disinhibition, and 3) hunger. The Eating Inventory (also known as the three factor eating questionnaire) is separated into two parts. The first part consists of 36 questions and the second part consists of 15 questions. Part 1 allocates one point for each item (1-36). One point is given for each item on the Likert scale for Part 2 (i.e., 1 point given for "rarely" and three points given for "usually"). It is difficult to quantify a better or worse outcome here. Typically, higher scores in the cognitive constraint item, indicate greater conscious control over eating behavior. | 12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month) |
| Eating Behavior - Disinhibition | Eating Behavior will be measured via The Eating Inventory, which measures three factors related to eating behavior: 1) cognitive restraint, 2) disinhibition, and 3) hunger. The Eating Inventory (also known as the three factor eating questionnaire) is separated into two parts. The first part consists of 36 questions and the second part consists of 15 questions. Part 1 allocates one point for each item (1-36). One point is given for each item on the Likert scale for Part 2 (i.e., 1 point given for "rarely" and three points given for "usually"). It is difficult to quantify a better or worse outcome here. Typically, higher scores in Disinhibition signify a greater tendency to overeat or lose control over eating behavior. | 12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month) |
| Eating Behavior - Hunger | Eating Behavior will be measured via The Eating Inventory, which measures three factors related to eating behavior: 1) cognitive restraint, 2) disinhibition, and 3) hunger. The Eating Inventory (also known as the three factor eating questionnaire) is separated into two parts. The first part consists of 36 questions and the second part consists of 15 questions. Part 1 allocates one point for each item (1-36). One point is given for each item on the Likert scale for Part 2 (i.e., 1 point given for "rarely" and three points given for "usually"). It is difficult to quantify a better or worse outcome here. Typically, a higher score in Hunger indicates greater subjective feelings of hunger and appetite. | 12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month) |
| Physical Activity | Objectively measured physical activity outcomes will be minutes of moderate to vigorous physical activity accumulated overall and in bouts of 10 minutes or longer as assessed by the activPAL. The activPAL is a wireless multi-sensor monitor worn on the thigh. This technology has been shown to accurately measure time engaged in physical activity intensity categories. Participants will wear the activPAL for 7 days at all assessment points. | 12 Months Overall (intervals of 7 days at baseline, 3 Month, 6 Month, 12 Month) |
| Weight-Related Medical Comorbidities - Number of participants with hypertension | Hypertension will be measured by participants undergoing a blood pressure check via blood pressure cuff. | 12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month) |
| Weight-Related Medical Comorbidities - Number of participants with diabetes | Diabetes will be measured by participants undergoing a blood draw to evaluate blood glucose and HbA1c (after a 12 hour fast). | 12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month) |
| Weight-Related Medical Comorbidities - Number of participants with hypercholesterolemia | Hypercholesterolemia will be measured by participants undergoing a blood draw to evaluate cholesterol levels and triglycerides (after a 12 hour fast). | 12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month) |
| Weight-Related Medical Comorbidities - Number of participants with hyperlipidemia | Hyperlipidemia will be measured by participants undergoing a blood draw to evaluate cholesterol levels and triglycerides (after a 12 hour fast). | 12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month) |
| 12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month) |
| Mechanisms of Action (Exploratory) - Mindfulness | Proposed mediators of treatment outcome will be assessed via self-report questionnaires. Acceptance The Philadelphia Mindfulness Scale (PHLMS) will be used to assess mindfulness. The PHLMS is a 20-question survey, where respondents rank choices on a 5 item Likert scale (1=Never and 5=Very often). Items on the PHLMS cover various aspects of mindfulness, including attention to present-moment experiences, awareness of thoughts and feelings, and the ability to maintain a non-judgmental and accepting stance toward one's experiences. The minimum value on this scale is 20 and the maximum value is 100. Typically, a higher score indicates greater levels of mindfulness. | 12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month) |
| Mechanisms of Action (Exploratory) - Defusion | Proposed mediators of treatment outcome will be assessed via self-report questionnaires. Defusion will be measured with the Drexel Defusion Scale (DDS), a self-report measure assessing the extent of the ability to defuse from different internal experiences. The DDS is a 12-item questionnaire that is scored on a 6 level Likert scale (0=Not at all, 5=Very often). The minimum value on this scale is 0, while the maximum value on this scale is 60. Higher scores tend to indicate greater cognitive defusion (the ability to observe thoughts without getting entangled), while lower scores indicate greater cognitive fusion (being entangled with thoughts). | 12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month) |
| Mechanisms of Action (Exploratory) - Values clarity | Proposed mediators of treatment outcome will be assessed via self-report questionnaires. Values clarity will be measured with the Valued Living Questionnaire (VLQ). The VLQ consists of two parts. Part 1 asks respondents to rank life domains on a scale of 1-10, indicating their level of importance, and Part 2 asks respondents to rank consistency of actions with life values on a scale of 1-10. The VLQ is scored as a composite, and the mean composite score is ~61. Overall, it can be useful to look at consistent to see if an individual's actions are consistent with their values, it can be useful to view domains that are the most top-ranked, and it can be useful to get an overall picture of an individual's sense of fulfillment. In general, a high composite score would indicate that an individual places high value on their identified life domains and reports high consistency between their values and actions. | 12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month) |
| Mechanisms of Action (Exploratory) - Depressive symptoms | Proposed mediators of treatment outcome will be assessed via self-report questionnaires. The Patient Health Questionnaire-9 (PHQ-9) will be used to assess depressive symptoms. The PHQ-9 consists of 9 items that are ranked on a 4-point Likert scale (0=Not at all, 3=Nearly every day). The minimum value on this scale is a 0 and the maximum value on this scale is 27. Generally, higher scores indicate more severe depressive symptoms. | 12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month) |
| Mechanisms of Action (Exploratory) - Anxiety | Proposed mediators of treatment outcome will be assessed via self-report questionnaires. The Generalized Anxiety Disorder-7 (GAD-7) will be used to assess symptoms of anxiety. The GAD-7 consists of 7 items that are ranked on a 4-point Likert scale (0=Not at all, 3=Nearly every day). The minimum value on this scale is a 0 and the maximum value on this scale is 21. Generally, higher scores indicate more severe anxiety symptoms. | 12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month) |
| Mechanisms of Action (Exploratory) - Internal states | Levels of hunger and food cravings will be measured via ratings on a 5-point Likert-scale (1 - "disagree strongly" to 5 - "agree strongly") in response to the questions "Please rate the extent to which you agree with the following statement: I am craving food" and "Please rate the extent to which you agree with the following statement: I am hungry." Ratings of >4 will be classified as high levels of hunger and food cravings.This previously used method will be adapted to measure urges to overeat (i.e., "Please rate the extent to which you agree with the following statement: I am having the urge to overeat."). The Negative Affect scale will be used to measure negative affect, as adapted from the Positive and Negative Affect Scale (PANAS). | 12 Months Overall (intervals of 7 days at baseline, 3 Month, 6 Month, 12 Month) |
| Mechanisms of Action (Exploratory) - Maladaptive eating behaviors | Loss of control eating will be assessed via responses to the following questions rated on a 5-point Likert scale (1 - "not at all" to 5 - "extremely"): "While you were eating, to what extent did you feel…" - 1) "…a sense of loss of control," 2) "…that you could not resist eating?", 3) "…that you could not stop eating once you started," and 4) "…driven or compelled to eat?" For emotional eating, questions will include "While you were eating, to what extent did you…" 1) "…comfort yourself with food," and 2) "… overeat when you were stressed, angry, frustrated, upset, or anxious." For grazing, the following question will be asked in regard to eating episodes: "While you were eating, to what extent did you eat small or modest amounts of food in a repetitive and unplanned manner." Maladaptive eating behaviors will be considered present when a rating of >3 (i.e., "moderately") is made on at least one of the questions. | 12 Months Overall (intervals of 7 days at baseline, 3 Month, 6 Month, 12 Month) |
| Temple University | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| The Drexel defusion scale | View source |
| Eating Inventory Manual | View source |
| ASA24 | View source |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |