Gaining Optimism After Weight Loss Surgery (GOALS) II: Randomized Controlled Trial of a Positive Psychology-based Intervention to Increase Physical Activity After Bariatric Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 58
- Locations
- 2
- Primary Endpoint
- Ease and utility of intervention sessions
Study Overview
Brief Summary
This randomized controlled trial 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 compared to an enhanced usual care control.
Detailed Description
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 compared to an enhanced usual care control. The investigators will enroll and randomize 58 participants. Study participation includes attending four study visits (two at baseline, one at 10 weeks, and one at 24 weeks). Participants will be randomized either to a 10-week physical activity intervention that includes once-weekly phone calls, a written manual, and a Fitbit activity tracker, or provision of the Fitbit alone. Primary outcomes include the feasibility and acceptability of the intervention. Secondary outcomes include changes in physical activity and other psychological, behavioral, and physiological outcomes at 10 and 24 weeks compared to the control.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
A research assistant blinded to study condition will conduct follow-up assessment visits.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Severe psychiatric condition limiting ability to participate (e.g., psychosis, active substance use disorder)
Outcomes
Primary Outcomes
Ease and utility of intervention sessions
Time Frame: 10 weeks
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.
Number of intervention sessions completed
Time Frame: 10 weeks
Feasibility will be measured by examining the number of completed intervention sessions for individuals randomized to the PP-MI intervention. The intervention will be considered feasible if at least 7/10 sessions are completed, on average.
Secondary Outcomes
- Change in Depressive symptoms(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Steps(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Light Physical Activity(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Anxiety(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Motivation to change(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Exercise Identity(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Self-Reported Physical Activity(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Body weight(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in A1C(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Positive Affect(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Optimism(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Exercise-specific Self-efficacy(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Blood pressure (millimeters of mercury)(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Social support for exercise(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Body composition(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Physical activity enjoyment(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Sedentary Time(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Negative Affect(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Body Image(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Aerobic capacity and endurance(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Social support for eating habits(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Waist circumference (in centimeters)(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Lipids(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Inflammation(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Moderate to Vigorous Physical Activity (MVPA)(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in General Self-Efficacy(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Internalized Weight Bias(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Bariatric Surgery-specific Diet and Vitamin Adherence(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
Investigators
Emily Feig, Ph.D.
Instructor in Psychology
Massachusetts General Hospital