Gaining Optimism After Weight Loss Surgery (GOALS) II

Mass General Brigham

Status: Enrolling

Conditions: Bariatric Surgery

Treatments: Behavioral: Positive Psychology-Motivational Interviewing; Behavioral: Physical Activity Education Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04868032

2021P001006b

5K23HL148017 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

Positive Psychology-Motivational Interviewing Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Positive Psychology-Motivational Interviewing

Physical Activity Education Control

Active Comparator group

Description:

Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.

Treatment:

Behavioral: Physical Activity Education Control