Gaining Optimism After Weight Loss Surgery (GOALS) II (GOALS)

  • STATUS
    Recruiting
  • End date
    Jul 1, 2024
  • participants needed
    58
  • sponsor
    Massachusetts General Hospital
Updated on 4 October 2022

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.

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.

Details
Condition Bariatric Surgery
Treatment Positive Psychology-Motivational Interviewing, Physical Activity Education Control
Clinical Study IdentifierNCT04868032
SponsorMassachusetts General Hospital
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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 moderateto -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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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