Gaining Optimism After Weight Loss Surgery (GOALS) II

Bariatric Surgery Clinical Trial

— GOALS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04868032
• Other study ID #: 2021P001006b
• Secondary ID: 5K23HL148017
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: June 3, 2025

Study information

• Verified date: April 2024
• Source: Massachusetts General Hospital
• Contact: Emily H Feig, PhD
• Phone: 617-724-9140
• Email: efeig[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: June 3, 2025
• Est. primary completion date: June 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bariatric Surgery
• Weight Loss

Intervention

Behavioral:
• Positive Psychology-Motivational Interviewing
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.
• Physical Activity Education Control
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Ease and utility of intervention sessions	Acceptability will be measured with ratings of ease and utility after each exercise, measured on a 10-point Likert scale (1=very difficult/not at all helpful, 10=very easy/very helpful). The intervention will be considered acceptable if average ease and utility ratings are at least 7/10.	10 weeks
Secondary	Change in Moderate to Vigorous Physical Activity (MVPA)	We will use ActiGraph GT3X-BT accelerometers to objectively measure physical activity for 1 week at each assessment. MVPA will be measured in minutes/day.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Steps	Measured by Actigraph accelerometer, in number of steps per day.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Light Physical Activity	Measured by Actigraph accelerometer, in minutes per day.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Sedentary Time	Measured by Actigraph accelerometer, in minutes per day.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Positive Affect	The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect (Range: 10-50). Higher scores indicate higher levels of positive affect.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Negative Affect	The negative affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure negative affect (Range: 10-50). Higher scores indicate higher levels of negative affect.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Optimism	The Life Orientation Test-Revised (LOT-R) is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Higher scores indicate higher levels of optimism.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Depressive symptoms	The Hospital Anxiety and Depression Scale (HADS)-depression subscale will be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Higher scores indicate higher levels of depression.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Anxiety	The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale will be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Higher scores indicate higher levels of anxiety.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Motivation to change	The University of Rhode Island Change Assessment (URICA) is a well-validated, 32-item measure that will be used to assess motivation to change. Higher scores indicate higher motivation to change.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Exercise Identity	The Exercise Identity Scale (EIS) is a well-validated, 9-item measure that will be used to assess exercise identity (Range: 9-63). Higher scores indicate stronger exercise identity.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in General Self-Efficacy	Self-efficacy will be measured using the General Self Efficacy scale (GSE), a validated measure of self-efficacy, given its links to improved adherence. Higher scores indicate greater self-efficacy.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Exercise-specific Self-efficacy	Exercise-specific self-efficacy will be measured by the Self-Efficacy for Exercise scale (SEE), a validated scale which assesses self-efficacy for exercise (Range: 0-90). Higher scores indicate higher self-efficacy.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Internalized Weight Bias	The Weight Bias Internalization Scale - Modified (WBIS-M) is a well-validated, 11-item measure that will be used to measure internalized weight bias (Range: 11-77). Higher scores indicate greater internalized weight bias.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Body Image	Body image will be assessed using the Multidimensional Body-Self Relations Questionnaire (MBSRQ). Higher scores indicate better body image.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Bariatric Surgery-specific Diet and Vitamin Adherence	The Bariatric Surgery Self-Management Questionnaire (BSSQ) is a validated measure that will be used to assess adherence to diet and vitamin recommendations after bariatric surgery. Higher scores indicate better adherence to diet and vitamin recommendations.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Self-Reported Physical Activity	The International Physical Activity Questionnaire (IPAQ) - Short Form is a well-validated 7-day physical activity recall assessment for physical activity. Activity will be measured by the number of MET-minutes of moderate or greater activity per week.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Body weight	Body weight (in kilograms) will be measured on a calibrated scale.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Waist circumference (in centimeters)	Waist circumference will be measured by a nurse.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Blood pressure (millimeters of mercury)	Blood pressure will be measured by a nurse.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Aerobic capacity and endurance	The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Social support for exercise	The Social Support and Exercise Survey is a 13-item validated measure that assesses social support for exercising from family and friends over the past 3 months. Scores range from 13 to 104, with higher scores indicating more social support.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Social support for eating habits	The Social Support and Eating Habits Survey is a 10-item validated measure that assesses social support for healthy eating from family and friends over the past 3 months. Scores range from 10 to 80, with higher scores indicating more social support.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Body composition	The measurement of body fat in relation to lean body mass will be measured using bio-electrical impedance.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in A1C	Hemoglobin A1C will be measured via blood draw.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Lipids	Lipids will be measured via blood draw.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Inflammation	C-reactive protein will be measured via blood draw as a measure of inflammation.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Secondary	Change in Physical activity enjoyment	Self-efficacy will be measured using the Physical Activity Enjoyment Scale (PACES), a validated measure of enjoyment during exercise. Higher scores indicate greater enjoyment during exercise.	Baseline, 10-Week Follow-Up, 24-Week Follow-Up