Clinical trial NCT04867902: Gaining Optimism After Weight Loss Surgery (GOALS) I
Official title: 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
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: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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 and 10-Week Follow-Up
measure: Change in Steps
timeFrame: Baseline and 10-Week Follow-Up
measure: Change in Light Physical Activity
timeFrame: Baseline and 10-Week Follow-Up
measure: Change in Sedentary Time
timeFrame: Baseline and 10-Week Follow-Up
measure: Change in Optimism
timeFrame: Baseline and 10-Week Follow-Up
measure: Change in Depressive Symptoms
timeFrame: Baseline and 10-Week Follow-Up
measure: Change in Anxiety
timeFrame: Baseline and 10-Week Follow-Up
measure: Change in Motivation to Change
timeFrame: Baseline and 10-Week Follow-Up
measure: Change in Exercise Identity
timeFrame: Baseline and 10-Week Follow-Up
measure: Change in General Self-Efficacy
timeFrame: Baseline and 10-Week Follow-Up
measure: Change in Exercise-specific Self-efficacy
timeFrame: Baseline and 10-Week Follow-Up
measure: Change in Internalized Weight Bias
timeFrame: Baseline and 10-Week Follow-Up
measure: Change in Body Image
timeFrame: Baseline and 10-Week Follow-Up
measure: Change in Bariatric Surgery-specific Diet and Vitamin Adherence
timeFrame: Baseline and 10-Week Follow-Up
measure: Change in Self-Reported Physical Activity
timeFrame: Baseline and 10-Week Follow-Up
measure: Change in Body Weight
timeFrame: Baseline and 10-Week Follow-Up
measure: Change in Waist Circumference (in Centimeters)
timeFrame: Baseline and 10-Week Follow-Up
measure: Change in Systolic Blood Pressure
timeFrame: Baseline and 10-Week Follow-Up
measure: Change in Aerobic Capacity and Endurance
timeFrame: Baseline and 10-Week Follow-Up
measure: Change in Social Support for Exercise
timeFrame: Baseline and 10-Week Follow-Up
measure: Change in Social Support for Eating Habits - Encouragement Subscale
timeFrame: Baseline and 10-Week Follow-Up
measure: Change in Body Composition
timeFrame: Baseline and 10-Week Follow-Up
measure: Change in A1C
timeFrame: Baseline and 10-Week Follow-Up
measure: Change in High-density Lipoprotein (HDL)
timeFrame: Baseline and 10-Week Follow-Up
measure: Change in Inflammation
timeFrame: Baseline and 10-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: