Feasibility and Preliminary Efficacy of Support Figure Attendance at Bariatric Patients' Clinical Visits

Study Overview
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Brief Summary
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The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy for the inclusion of support figures and romantic partners throughout the bariatric surgery process, from pre-surgery to two months post-surgery. This will be done using a four-arm randomized controlled trial (RCT). Using simple randomization, female patients in romantic relationships will be randomized into partner attended (PA) groups and treatment as usual (PA-TU) groups; patients (female or male) not in romantic relationships will be randomized into support figure attended (SFA) and SFA-TU groups. The goals of this study are to provide preliminary evidence for including support figures/partners in patients' routine BS healthcare visits, including the subsequent impact on post-surgery patient and support figure/partner behavior change and weight loss, relationship outcomes, and exploration of barriers to support figure/partner involvement. Aim 1: To assess the feasibility and acceptability of support figure/partner involvement for BS patients. Feasibility will be assessed throughout the study by attendance at the four pre-surgery classes and the clinic visit assessment time points. Perceived fiscal and time involved in the study will be assessed. Acceptability will be assessed from patient and support figure/partner interviews regarding the barriers and benefits to attendance, and alternative mediums to engage support figures/partners. Aim 2: To evaluate the effect of support figure/partner attendance (SFA, PA arms) on patient weight loss, behavior change, and relationship outcomes from T1-T4. Estimates of effect size and variance in patient weight loss and behavior change will be collected from T1-T4 for comparison of the SFA/PA and SFA-TU/PA-TU arms.

Detailed Description
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The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy for the inclusion of support figures and romantic partners throughout the bariatric surgery process, from pre-surgery to two months post-surgery. This will be done using a four-arm randomized controlled trial (RCT). Using simple randomization, female patients in romantic relationships will be randomized into partner attended (PA) groups and treatment as usual (PA-TU) groups; patients (female or male) not in romantic relationships will be randomized into support figure attended (SFA) and SFA-TU groups. The goals of this study are to provide preliminary evidence for including support figures/partners in patients' routine BS healthcare visits, including the subsequent impact on post-surgery patient and support figure/partner behavior change and weight loss, relationship outcomes, and exploration of barriers to support figure/partner involvement. Inclusion criteria for the PA arm requires patients be pre-surgery and registered for pre-surgery classes, identify as female, and in a romantic relationship with a cohabitating partner/spouse for at least 6 months. Inclusion criteria for the SFA arm requires patients be pre-surgery and registered for pre-surgery classes, and not be in a cohabitating romantic relationships. Known terminal illness diagnosis excludes patients and support figure/partner participation. The recruitment goal is 110 dyads in all four arms of the study (SFA, SFA-TU, PA, PA-TU). Patients in all arms will receive routine care, which includes four pre-surgery classes and routine clinical visits. Support figures/partners of patients in the SFA and PA arms will be requested to attend the four pre-surgery classes with the patient and the three clinical visits; patients in the SFA-TU and PA-TU arms will attend individually. Assessments will be completed by patients and support figures/partners (all four arms) at the first pre-surgery class (T1) and routine clinical visits: the pre-surgery appointment (T2), two-weeks post-surgery appointment (T3), and at the two-months post-surgery appointment (T4). Aim 1: To assess the feasibility and acceptability of support figure/partner involvement for BS patients. Feasibility will be assessed throughout the study by attendance at the four pre-surgery classes and the clinic visit assessment time points. Perceived fiscal and time involved in the study will be assessed. Acceptability will be assessed from patient and support figure/partner interviews regarding the barriers and benefits to attendance, and alternative mediums to engage support figures/partners. Aim 2: To evaluate the effect of support figure/partner attendance (SFA, PA arms) on patient weight loss, behavior change, and relationship outcomes from T1-T4. Estimates of effect size and variance in patient weight loss and behavior change will be collected from T1-T4 for comparison of the SFA/PA and SFA-TU/PA-TU arms. Hypothesis. Patients in the SFA and PA arms will experience increased weight loss, physical activity frequency, and higher compliance with post-surgery dietary recommendations compared to patients in the SFA-TU and PA-TU arms at T4. Sub-aim 2.1. To evaluate the effect of attendance on support figure/partner weight status. Support figures and partners will complete measures of weight status at the same time points as the patient. Because it is largely unknown if support figures/partners could benefit from intervention with the patient, or if support figures/partners' weight status is similar to the patients, we will explore support figures/partners' weight status and if their weight status changes from T1 to T4. Sub-aim 2.2. To determine the preliminary effect of attendance on relationship outcomes. Patients and support figures/partners will complete self-report measures of relationship quality (PA-only), attachment security (PA-only), family functioning, and perceived social support from T1-T4 to determine the effect of attendance on patient and support figure/partners' perspectives of relationship outcomes.

Official Title
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Feasibility and Preliminary Efficacy of Support Figure Attendance at Bariatric Patients' Clinical Visits

Conditions
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Obesity, Morbid, Bariatric Surgery Candidate, Diet Habit, Behavior, Social, Physical Activity

Intervention / Treatment
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* Behavioral: Attendance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in all arms must be ≥18 years-old, seeking bariatric surgery, speak and read/write English Partners and support figures must be ≥18 years old, speak and read/write English, and have no prior history of BS Partners in the PA and PA-TAU arms must be in a romantic relationship and cohabitate with the patient for at least 6 months Exclusion Criteria: No known terminal health diagnosis (i.e., Cancer) In the PA and PA-TAU arms, no known domestic violence or abuse between partners

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A four-arm randomized controlled trial (RCT) using simple randomization will randomize female patients in romantic relationships into partner attended (PA) groups and treatment as usual (PA-TU) groups; patients (female or male) not in romantic relationships will be randomized into support figure attended (SFA) and SFA-TU groups. Patients in all arms will receive routine care. Support figures/partners of patients in the SFA and PA arms will be requested to attend the four pre-surgery classes with the patient and the three clinical visits; patients in the SFA-TU and PA-TU arms will attend individually. Assessments will be completed by patients and support figures/partners (all four arms) at the first pre-surgery class (T1) and routine clinical visits: the pre-surgery appointment (T2), two-weeks post-surgery appointment (T3), and at the two-months post-surgery appointment (T4). The study will follow all groups for roughly six months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Support Figure Attended (SFA)<br>Using simple randomization patients (female or male) not in romantic relationships will be randomized into support figure attended (SFA) and SFA-TU groups. Patients in all arms will receive routine care, which includes four pre-surgery classes and routine clinical visits. Support figures in the SFA arm will be requested to attend the four pre-surgery classes with the patient and the three clinical visits. The intervention is support figure attendance. Assessments will be completed by patients and support figures at the first pre-surgery class (T1) and routine clinical visits: the pre-surgery appointment (T2), two-weeks post-surgery appointment (T3), and at the two-months post-surgery appointment (T4). | Behavioral: Attendance<br>* The SFA and PA arms will be instructed to attend pre-surgery classes and clinical visits with the patients.<br>|
| No Intervention: SFA - Treatment as Usual (SFA-TAU)<br>Using simple randomization patients (female or male) not in romantic relationships will be randomized into support figure attended (SFA) and SFA-TU groups. Patients in all arms will receive routine care, which includes four pre-surgery classes and routine clinical visits. Support figures in the SFA-TU arm will not be requested to attend the four pre-surgery classes with the patient and the three clinical visits- patients will attend alone. Assessments will be completed by patients and support figures at the first pre-surgery class (T1) and routine clinical visits: the pre-surgery appointment (T2), two-weeks post-surgery appointment (T3), and at the two-months post-surgery appointment (T4). | |
| Experimental: Partner Attended (PA)<br>Using simple randomization female patients in cohabiting romantic relationships for at least 6 months will be randomized into partner attended (PA) and PA-TU groups. Patients in all arms will receive routine care, which includes four pre-surgery classes and routine clinical visits. Partners in the PA arm will be requested to attend the four pre-surgery classes with the patient and the three clinical visits. The intervention is partner attendance. Assessments will be completed by patients and partners at the first pre-surgery class (T1) and routine clinical visits: the pre-surgery appointment (T2), two-weeks post-surgery appointment (T3), and at the two-months post-surgery appointment (T4). | Behavioral: Attendance<br>* The SFA and PA arms will be instructed to attend pre-surgery classes and clinical visits with the patients.<br>|
| No Intervention: PA - Treatment as Usual (PA-TAU)<br>Using simple randomization female patients in cohabiting romantic relationships for at least 6 months will be randomized into partner attended (PA) and PA-TU groups. Patients in all arms will receive routine care, which includes four pre-surgery classes and routine clinical visits. Partners in the PA-TU arm will not be requested to attend the four pre-surgery classes with the patient and the three clinical visits- patients will attend alone. Assessments will be completed by patients and partners at the first pre-surgery class (T1) and routine clinical visits: the pre-surgery appointment (T2), two-weeks post-surgery appointment (T3), and at the two-months post-surgery appointment (T4). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Excess Weight Loss (%EWL, Patient) | [(T1 weight in lbs) - (Follow up (T2-T4) Weight)] / [(TI Weight) - (Ideal Weight)] | 6 months, 4 time points | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary Compliance (Patient) | Trained dieticians will conduct oral 24-hour recalls with patients and rate as (0) not compliant or (1) compliant. Ratings are based on the American Society of Metabolic Bariatric Surgery (ASMBS) surgery guidelines. | 6 months, 4 time points | 
| Physical Activity (Patient) | Scale Name: Bouchard's Physical Activity Record. Items 1-9 are totaled to assess physical activity intensity, ranging from 24-96, where higher scores indicate higher intensity of activity throughout the day. | 6 months, 4 time points | 
| Relationship Quality (Patient and Partner) | Scale Name: Abbreviated Dyadic Assessment Scale (ADAS). There are 7 items to assess relationship quality on a continuous scale from 0-35, where higher scores indicate higher relationship quality. Items are scored on a 0-5 scale for items 1-6, and 0-6 scale for item 7. | 6 months, 4 time points | 
| Perceived Social Support for Behavior Change (Patient and Partner/Support Figure) | Scale Name: Social Support for Eating Habits and Exercise. There are 23 items scored on a continuous scale ranging from 23-115 to assess perceived social support for behavior change, where higher scores indicate higher perceived support. Each item is scored on a scale ranging from 1-5. There are four subscales 1) encouragement of eating habits (items: 1-5); 2) discouragement of eating habits (6-10); and 3) family participation in exercise (items 11-16, 20-23); and 4) punishment for exercise (items: 17-19). | 6 months, 4 time points | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric Surgery, Obesity, Social Support, Health Behavior