RemI for Post-Bariatric Surgery Weight Regain

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTemple University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Men and women

Ages 18-70 years old

Weight regain of at least 5% from lowest postoperative weight

Body mass index (BMI) 25 or above

Disqualifiers

Long-term treatment with oral steroids

Current use of weight loss medication (OTC or prescription)

Current pregnancy, plan to become pregnant within 12 months, lactation within the past 6 months

Psychiatric hospitalization in the past 6 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Acceptance-Based Behavioral InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)

Secondary outcomes

1

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.

Time frame
12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)
2

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.

Time frame
12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)
3

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.

Time frame
12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)
4

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.

Time frame
12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)

Other outcomes

1

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.

Time frame
12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)
2

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.

Time frame
12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)
3

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).

Time frame
12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)
4

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.

Time frame
12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)

Sponsors and contacts

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Temple University

Lead sponsor

Rush University

Collaborator