Gaining Optimism After Weight Loss Surgery (GOALS) I

Study Overview
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Brief Summary
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This study examines the feasibility, acceptability, and preliminary impact of an adapted positive psychology-motivational interviewing (PP-MI) intervention for physical activity among patients who have recently undergone bariatric surgery.

Detailed Description
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This study will test a positive psychology-motivational interviewing (PP-MI) intervention for physical activity promotion in patients who have had bariatric surgery within the past 6-12 months. The investigators will enroll 12 participants. Study participation includes attending three study visits (two at baseline, one after the intervention) and receiving a 10-week physical activity intervention that includes once-weekly phone calls, a written manual, and a Fitbit activity tracker. Primary outcomes are feasibility and acceptability of the intervention and study procedures. Secondary outcomes include pre-post changes in physical activity and other psychological, behavioral, and physiological outcomes.

Official Title
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Gaining Optimism After Weight Loss Surgery (GOALS) I: Proof-of-Concept Trial of a Positive Psychology-based Intervention to Increase Physical Activity After Bariatric Surgery

Conditions
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Bariatric Surgery

Intervention / Treatment
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* Behavioral: Positive Psychology-Motivational Interviewing Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (age 18+) History of bariatric surgery (gastric bypass or sleeve gastrectomy) at one of two academic medical centers within the past 6-12 months Interest in increasing physical activity Low physical activity, defined as <200 minutes/week self-reported moderate- to-vigorous physical activity Access to telephone for study sessions Able to read and speak English Exclusion Criteria: Cognitive deficits precluding participation or informed consent Illness likely to lead to death in the next 6 months Inability to be physically active (e.g., severe arthritis) Participation in another program targeting physical activity besides their standard offerings at the surgery center.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive Psychology-Motivational Interviewing Intervention<br>Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics. | Behavioral: Positive Psychology-Motivational Interviewing Intervention<br>* Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Intervention Sessions Completed | Feasibility will be measured by examining the number of completed intervention sessions. The intervention will be considered feasible if at least 7/10 sessions are completed, on average. | 10 weeks | 
| Ease and Utility of Intervention Sessions | Acceptability will be measured with ratings of ease and utility after each exercise, measured on a 10-point Likert scale (1=very difficult/not at all helpful, 10=very easy/very helpful). The intervention will be considered acceptable if average ease and utility ratings are at least 7/10. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Moderate to Vigorous Physical Activity (MVPA) | We will use ActiGraph GT3X-BT accelerometers to objectively measure physical activity for 1 week at each assessment. MVPA will be measured in minutes/week. | Baseline and 10-Week Follow-Up | 
| Change in Steps | Measured by Actigraph accelerometer, in number of steps per day. | Baseline and 10-Week Follow-Up | 
| Change in Light Physical Activity | Measured by Actigraph accelerometer, in minutes per week. | Baseline and 10-Week Follow-Up | 
| Change in Sedentary Time | Measured by Actigraph accelerometer, in minutes per day. | Baseline and 10-Week Follow-Up | 
| Change in Optimism | The Life Orientation Test-Revised (LOT-R) is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Higher scores indicate higher levels of optimism. | Baseline and 10-Week Follow-Up | 
| Change in Depressive Symptoms | The Hospital Anxiety and Depression Scale (HADS)-depression subscale will be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Higher scores indicate higher levels of depression. | Baseline and 10-Week Follow-Up | 
| Change in Anxiety | The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale will be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Higher scores indicate higher levels of anxiety. | Baseline and 10-Week Follow-Up | 
| Change in Motivation to Change | The University of Rhode Island Change Assessment (URICA) is a well-validated, 32-item measure that will be used to assess motivation to change. Higher scores indicate higher motivation to change. Scores range from -2 to 14. | Baseline and 10-Week Follow-Up | 
| Change in Exercise Identity | The Exercise Identity Scale (EIS) is a well-validated, 9-item measure that will be used to assess the extent to which exercise contributes to one's role-identity (Range: 9-63). Higher scores indicate stronger exercise identity. | Baseline and 10-Week Follow-Up | 
| Change in General Self-Efficacy | Self-efficacy will be measured using the General Self Efficacy scale (GSE), a validated measure of self-efficacy, given its links to improved adherence. Higher scores indicate greater self-efficacy. Possible scores range from 10-40. | Baseline and 10-Week Follow-Up | 
| Change in Exercise-specific Self-efficacy | Exercise-specific self-efficacy will be measured by the Self-Efficacy for Exercise scale (SEE), a validated scale which assesses self-efficacy for exercise (Range: 0-90). Higher scores indicate higher self-efficacy. | Baseline and 10-Week Follow-Up | 
| Change in Internalized Weight Bias | The Weight Bias Internalization Scale - Modified (WBIS-M) is a well-validated, 11-item measure that will be used to measure internalized weight bias (Range: 11-77). Higher scores indicate greater internalized weight bias. | Baseline and 10-Week Follow-Up | 
| Change in Body Image | Body image will be assessed using the Multidimensional Body-Self Relations Questionnaire (MBSRQ) Appearance Evaluation subscale. Higher scores indicate better body image and possible scores range from 1-5. | Baseline and 10-Week Follow-Up | 
| Change in Bariatric Surgery-specific Diet and Vitamin Adherence | The Bariatric Surgery Self-Management Questionnaire (BSSQ) is a validated measure that will be used to assess adherence to diet and vitamin recommendations after bariatric surgery. Higher scores indicate better adherence to diet and vitamin recommendations. Possible scores range from 0-66. | Baseline and 10-Week Follow-Up | 
| Change in Self-Reported Physical Activity | The International Physical Activity Questionnaire (IPAQ) - Short Form is a well-validated 7-day physical activity recall assessment for physical activity. Activity will be measured by the number of minutes per day of moderate or greater activity per week. | Baseline and 10-Week Follow-Up | 
| Change in Body Weight | Body weight (in pounds) will be measured on a calibrated scale. | Baseline and 10-Week Follow-Up | 
| Change in Waist Circumference (in Centimeters) | Waist circumference will be measured by a nurse. | Baseline and 10-Week Follow-Up | 
| Change in Systolic Blood Pressure | Blood pressure will be measured by a nurse in mmHG. | Baseline and 10-Week Follow-Up | 
| Change in Aerobic Capacity and Endurance | The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. | Baseline and 10-Week Follow-Up | 
| Change in Social Support for Exercise | The Social Support and Exercise Survey is a 13-item validated measure that assesses social support for exercising from family and friends over the past 3 months. Scores range from 20 to 200, with higher scores indicating more social support. | Baseline and 10-Week Follow-Up | 
| Change in Social Support for Eating Habits - Encouragement Subscale | The Social Support and Eating Habits Survey encouragement subscale is a 5-item validated measure that assesses social support for healthy eating from family and friends over the past 3 months. Scores range from 10 to 80, with higher scores indicating more social support. | Baseline and 10-Week Follow-Up | 
| Change in Body Composition | The measurement of body fat in relation to lean body mass will be measured using bio-electrical impedance. | Baseline and 10-Week Follow-Up | 
| Change in A1C | Hemoglobin A1C will be measured via blood draw. A higher percentage means higher blood glucose values. | Baseline and 10-Week Follow-Up | 
| Change in High-density Lipoprotein (HDL) | HDL will be measured via blood draw. Higher levels of HDL in the blood means better absorption and clearing of cholesterol. | Baseline and 10-Week Follow-Up | 
| Change in Inflammation | C-reactive protein will be measured via blood draw as a measure of inflammation in mg/dL. | Baseline and 10-Week Follow-Up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positive Psychology, Motivational Interviewing, Physical Activity