Clinical trial NCT04868032: Gaining Optimism After Weight Loss Surgery (GOALS) II
Official title: Gaining Optimism After Weight Loss Surgery (GOALS) II: Randomized Controlled Trial of a Positive Psychology-based Intervention to Increase Physical Activity After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery
Keywords: Positive Psychology
Motivational Interviewing
Physical Activity
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-04-30
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of intervention sessions completed
timeFrame: 10 weeks
measure: Ease and utility of intervention sessions
timeFrame: 10 weeks
Secondary outcomes:
measure: Change in Moderate to Vigorous Physical Activity (MVPA)
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Steps
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Light Physical Activity
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Sedentary Time
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Positive Affect
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Negative Affect
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Optimism
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Depressive symptoms
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Anxiety
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Motivation to change
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Exercise Identity
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in General Self-Efficacy
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Exercise-specific Self-efficacy
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Internalized Weight Bias
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Body Image
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Bariatric Surgery-specific Diet and Vitamin Adherence
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Self-Reported Physical Activity
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Body weight
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Waist circumference (in centimeters)
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Blood pressure (millimeters of mercury)
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Aerobic capacity and endurance
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Social support for exercise
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Social support for eating habits
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Body composition
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in A1C
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Lipids
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Inflammation
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
measure: Change in Physical activity enjoyment
timeFrame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Emily H Feig, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feig EH, Harnedy LE, Thorndike AN, Psaros C, Healy BC, Huffman JC. A Positive Emotion-Focused Intervention to Increase Physical Activity After Bariatric Surgery: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Oct 6;11(10):e39856. doi: 10.2196/39856.