RemI for Post-Bariatric Surgery Weight Regain

Obesity Clinical Trial

Official title:

Evaluation of a Remotely-Delivered Behavioral Intervention for Post-Bariatric Surgery Weight Regain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06292936
• Other study ID #: 30692
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 4, 2024
• Est. completion date: April 1, 2028

Study information

• Verified date: February 2024
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

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 Control.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 1, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Men and women

• Ages 18-70 years old

• Weight regain of at least 5% from lowest postoperative weight

• Underwent gastric bypass or sleeve gastrectomy within 6 to 48 months prior to enrollment

• Ability to give consent

• Ability to speak, write, and understand English

Exclusion Criteria:

• Long-term treatment with oral steroids

• Current use of weight loss medication (OTC or prescription)

• Current pregnancy or plan to become pregnant within 12 months

• Psychiatric hospitalization in the past 6 months

• Documented or self-reported psychiatric diagnosis that would interfere with adherence to the study protocol or acute suicidality

• Self-report of alcohol or substance abuse within the past 12 months

• Current, self-reported use of tobacco products

• Weight loss > 10 lbs in the past 3 month

• History of more than one bariatric procedure

• Inability to walk at least one city block without assistance

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity

Intervention

Behavioral:
• Acceptance-Based Behavioral Intervention
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).

Locations

Country	Name	City	State
United States	Rush University	Chicago	Illinois
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	Rush University

Country where clinical trial is conducted

United States, 

References & Publications (79)

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Weineland S, Arvidsson D, Kakoulidis TP, Dahl J. Acceptance and commitment therapy for bariatric surgery patients, a pilot RCT. Obes Res Clin Pract. 2012 Jan-Mar;6(1):e1-e90. doi: 10.1016/j.orcp.2011.04.004. — View Citation

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* Note: There are 79 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   ASA24
•   Eating Inventory Manual
•   The Drexel defusion scale