Gaining Optimism After Weight Loss Surgery (GOALS) I

Not Applicable

Completed

Conditions: Bariatric Surgery

Interventions: Behavioral: Positive Psychology-Motivational Interviewing Intervention

Registration Number: NCT04867902

Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed 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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 12

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Positive Psychology-Motivational Interviewing Intervention	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.

Primary Outcome Measures

Name	Time	Method
Number of Intervention Sessions Completed	10 weeks	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.
Ease and Utility of Intervention Sessions	10 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Motivation to Change	Baseline and 10-Week Follow-Up	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.
Change in Exercise-specific Self-efficacy	Baseline and 10-Week Follow-Up	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.
Change in Steps	Baseline and 10-Week Follow-Up	Measured by Actigraph accelerometer, in number of steps per day.
Change in Internalized Weight Bias	Baseline and 10-Week Follow-Up	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.
Change in Systolic Blood Pressure	Baseline and 10-Week Follow-Up	Blood pressure will be measured by a nurse in mmHG.
Change in Light Physical Activity	Baseline and 10-Week Follow-Up	Measured by Actigraph accelerometer, in minutes per week.
Change in Moderate to Vigorous Physical Activity (MVPA)	Baseline and 10-Week Follow-Up	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.
Change in Sedentary Time	Baseline and 10-Week Follow-Up	Measured by Actigraph accelerometer, in minutes per day.
Change in Optimism	Baseline and 10-Week Follow-Up	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.
Change in Depressive Symptoms	Baseline and 10-Week Follow-Up	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.
Change in Anxiety	Baseline and 10-Week Follow-Up	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.
Change in General Self-Efficacy	Baseline and 10-Week Follow-Up	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.
Change in Body Image	Baseline and 10-Week Follow-Up	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.
Change in Waist Circumference (in Centimeters)	Baseline and 10-Week Follow-Up	Waist circumference will be measured by a nurse.
Change in Body Composition	Baseline and 10-Week Follow-Up	The measurement of body fat in relation to lean body mass will be measured using bio-electrical impedance.
Change in A1C	Baseline and 10-Week Follow-Up	Hemoglobin A1C will be measured via blood draw. A higher percentage means higher blood glucose values.
Change in Exercise Identity	Baseline and 10-Week Follow-Up	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.
Change in Aerobic Capacity and Endurance	Baseline and 10-Week Follow-Up	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.
Change in High-density Lipoprotein (HDL)	Baseline and 10-Week Follow-Up	HDL will be measured via blood draw. Higher levels of HDL in the blood means better absorption and clearing of cholesterol.
Change in Inflammation	Baseline and 10-Week Follow-Up	C-reactive protein will be measured via blood draw as a measure of inflammation in mg/dL.
Change in Bariatric Surgery-specific Diet and Vitamin Adherence	Baseline and 10-Week Follow-Up	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.
Change in Body Weight	Baseline and 10-Week Follow-Up	Body weight (in pounds) will be measured on a calibrated scale.
Change in Social Support for Eating Habits - Encouragement Subscale	Baseline and 10-Week Follow-Up	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.
Change in Self-Reported Physical Activity	Baseline and 10-Week Follow-Up	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.
Change in Social Support for Exercise	Baseline and 10-Week Follow-Up	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.