Gaining Optimism After Weight Loss Surgery (GOALS) I

Bariatric Surgery Clinical Trial

— GOALS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04867902
• Other study ID #: 2021P001006a
• Secondary ID: 5K23HL148017
• Status: Completed
• Phase: N/A
• Start date: June 29, 2021
• Est. completion date: June 22, 2022

Study information

• Verified date: August 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 22, 2022
• Est. primary completion date: June 22, 2022
• 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.

Related Conditions & MeSH terms

• Bariatric Surgery
• Weight Loss

Intervention

Behavioral:
• Positive Psychology-Motivational Interviewing Intervention
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.

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. 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/week.	Baseline and 10-Week Follow-Up
Secondary	Change in Steps	Measured by Actigraph accelerometer, in number of steps per day.	Baseline and 10-Week Follow-Up
Secondary	Change in Light Physical Activity	Measured by Actigraph accelerometer, in minutes per week.	Baseline and 10-Week Follow-Up
Secondary	Change in Sedentary Time	Measured by Actigraph accelerometer, in minutes per day.	Baseline and 10-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 and 10-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 and 10-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 and 10-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. Scores range from -2 to 14.	Baseline and 10-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 the extent to which exercise contributes to one's role-identity (Range: 9-63). Higher scores indicate stronger exercise identity.	Baseline and 10-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. Possible scores range from 10-40.	Baseline and 10-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 and 10-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 and 10-Week Follow-Up
Secondary	Change in Body Image	Body image will be assessed using the Multidimensional Body-Self Relations Questionnaire (MBSRQ) Appearance Evaluation subscale. Higher scores indicate better body image and possible scores range from 1-5.	Baseline and 10-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. Possible scores range from 0-66.	Baseline and 10-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 minutes per day of moderate or greater activity per week.	Baseline and 10-Week Follow-Up
Secondary	Change in Body Weight	Body weight (in pounds) will be measured on a calibrated scale.	Baseline and 10-Week Follow-Up
Secondary	Change in Waist Circumference (in Centimeters)	Waist circumference will be measured by a nurse.	Baseline and 10-Week Follow-Up
Secondary	Change in Systolic Blood Pressure	Blood pressure will be measured by a nurse in mmHG.	Baseline and 10-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 and 10-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 20 to 200, with higher scores indicating more social support.	Baseline and 10-Week Follow-Up
Secondary	Change in Social Support for Eating Habits - Encouragement Subscale	The Social Support and Eating Habits Survey encouragement subscale is a 5-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 and 10-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 and 10-Week Follow-Up
Secondary	Change in A1C	Hemoglobin A1C will be measured via blood draw. A higher percentage means higher blood glucose values.	Baseline and 10-Week Follow-Up
Secondary	Change in High-density Lipoprotein (HDL)	HDL will be measured via blood draw. Higher levels of HDL in the blood means better absorption and clearing of cholesterol.	Baseline and 10-Week Follow-Up
Secondary	Change in Inflammation	C-reactive protein will be measured via blood draw as a measure of inflammation in mg/dL.	Baseline and 10-Week Follow-Up