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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Number of Intervention Sessions Completed
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
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.
Arms & Interventions
Positive Psychology-Motivational Interviewing Intervention
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.
Intervention: Positive Psychology-Motivational Interviewing Intervention (Behavioral)
Outcomes
Primary Outcomes
Number of Intervention Sessions Completed
Time Frame: 10 weeks
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.
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.
Secondary Outcomes
- Change in Systolic Blood Pressure(Baseline and 10-Week Follow-Up)
- Change in Motivation to Change(Baseline and 10-Week Follow-Up)
- Change in Exercise-specific Self-efficacy(Baseline and 10-Week Follow-Up)
- Change in Steps(Baseline and 10-Week Follow-Up)
- Change in Internalized Weight Bias(Baseline and 10-Week Follow-Up)
- Change in Light Physical Activity(Baseline and 10-Week Follow-Up)
- Change in Moderate to Vigorous Physical Activity (MVPA)(Baseline and 10-Week Follow-Up)
- Change in Sedentary Time(Baseline and 10-Week Follow-Up)
- Change in Optimism(Baseline and 10-Week Follow-Up)
- Change in Depressive Symptoms(Baseline and 10-Week Follow-Up)
- Change in Anxiety(Baseline and 10-Week Follow-Up)
- Change in General Self-Efficacy(Baseline and 10-Week Follow-Up)
- Change in Body Image(Baseline and 10-Week Follow-Up)
- Change in Waist Circumference (in Centimeters)(Baseline and 10-Week Follow-Up)
- Change in Body Composition(Baseline and 10-Week Follow-Up)
- Change in A1C(Baseline and 10-Week Follow-Up)
- Change in Exercise Identity(Baseline and 10-Week Follow-Up)
- Change in Aerobic Capacity and Endurance(Baseline and 10-Week Follow-Up)
- Change in High-density Lipoprotein (HDL)(Baseline and 10-Week Follow-Up)
- Change in Inflammation(Baseline and 10-Week Follow-Up)
- Change in Bariatric Surgery-specific Diet and Vitamin Adherence(Baseline and 10-Week Follow-Up)
- Change in Body Weight(Baseline and 10-Week Follow-Up)
- Change in Social Support for Eating Habits - Encouragement Subscale(Baseline and 10-Week Follow-Up)
- Change in Self-Reported Physical Activity(Baseline and 10-Week Follow-Up)
- Change in Social Support for Exercise(Baseline and 10-Week Follow-Up)
Investigators
Emily Feig, Ph.D.
Instructor in Psychology
Massachusetts General Hospital