Gaining Optimism After Weight Loss Surgery (GOALS) II

NCT04868032 | Completed Results DMC

• 2 other identifiers: 2021P001006b5K23HL148017
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery

Keywords

Positive Psychology; Motivational Interviewing; Physical Activity

Outcome Measures

Primary Outcomes (2)

• Number of Intervention Sessions Completed

  Feasibility will be measured by examining the number of completed intervention sessions for individuals randomized to the PP-MI intervention. The intervention will be considered feasible if at least 7/10 sessions are completed, on average.

  10 weeks

• Intervention Acceptability

  After each of the 10 weekly intervention sessions, participants will rate that week's PP and goal-setting topics on how easy they were to complete and how helpful they were. Ratings will be measured on a 10-point Likert scale (1=very difficult/not at all helpful, 10=very easy/very helpful). Ratings for each category (e.g., ease of PP exercises) will be averaged across the 10 sessions to calculate a single value for that participant. The intervention will be considered acceptable if average ease and utility ratings are at least 7/10.

  10 weeks

Secondary Outcomes (24)

• Change in Moderate to Vigorous Physical Activity (MVPA)

  Baseline, 10-Week Follow-Up, 24-Week Follow-Up

• Change in Steps

  Baseline, 10-Week Follow-Up, 24-Week Follow-Up

• Change in Light Physical Activity

  Baseline, 10-Week Follow-Up, 24-Week Follow-Up

• Change in Positive Affect

  Baseline, 10-Week Follow-Up, 24-Week Follow-Up

• Change in Optimism

  Baseline, 10-Week Follow-Up, 24-Week Follow-Up

Study Arms (2)

Positive Psychology-Motivational Interviewing Intervention

EXPERIMENTAL

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.

Behavioral: Positive Psychology-Motivational Interviewing

Physical Activity Education Control

ACTIVE COMPARATOR

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.

Behavioral: Physical Activity Education Control

Interventions

Positive Psychology-Motivational Interviewing BEHAVIORAL

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.

Positive Psychology-Motivational Interviewing Intervention

Physical Activity Education Control BEHAVIORAL

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.

Physical Activity Education Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 36201380 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Emily Feig
• Organization: Massachusetts General Hospital

efeig@mgh.harvard.edu

617-724-9140

Study Officials

• Emily H Feig, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A research assistant blinded to study condition will conduct follow-up assessment visits.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Psychology

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: April 30, 2021
• Study Start: July 1, 2022
• Primary Completion: February 3, 2025
• Study Completion: June 3, 2025
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)