Gaining Optimism After Weight Loss Surgery (GOALS) II
- Conditions
- Bariatric Surgery
- Interventions
- Behavioral: Positive Psychology-Motivational InterviewingBehavioral: Physical Activity Education Control
- Registration Number
- NCT04868032
- Lead Sponsor
- Massachusetts General Hospital
- 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.
- 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 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 58
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Positive Psychology-Motivational Interviewing Intervention 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 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.
- Primary Outcome Measures
Name Time Method 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.
Number of intervention sessions completed 10 weeks 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.
- Secondary Outcome Measures
Name Time Method Change in Depressive symptoms Baseline, 10-Week Follow-Up, 24-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 Internalized Weight Bias Baseline, 10-Week Follow-Up, 24-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 Steps Baseline, 10-Week Follow-Up, 24-Week Follow-Up Measured by Actigraph accelerometer, in number of steps per day.
Change in Light Physical Activity Baseline, 10-Week Follow-Up, 24-Week Follow-Up Measured by Actigraph accelerometer, in minutes per day.
Change in Anxiety Baseline, 10-Week Follow-Up, 24-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 Motivation to change Baseline, 10-Week Follow-Up, 24-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.
Change in Exercise Identity Baseline, 10-Week Follow-Up, 24-Week Follow-Up 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.
Change in Self-Reported Physical Activity Baseline, 10-Week Follow-Up, 24-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 MET-minutes of moderate or greater activity per week.
Change in Body weight Baseline, 10-Week Follow-Up, 24-Week Follow-Up Body weight (in kilograms) will be measured on a calibrated scale.
Change in A1C Baseline, 10-Week Follow-Up, 24-Week Follow-Up Hemoglobin A1C will be measured via blood draw.
Change in Positive Affect Baseline, 10-Week Follow-Up, 24-Week Follow-Up 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.
Change in Optimism Baseline, 10-Week Follow-Up, 24-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 Exercise-specific Self-efficacy Baseline, 10-Week Follow-Up, 24-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 Blood pressure (millimeters of mercury) Baseline, 10-Week Follow-Up, 24-Week Follow-Up Blood pressure will be measured by a nurse.
Change in Social support for exercise Baseline, 10-Week Follow-Up, 24-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 13 to 104, with higher scores indicating more social support.
Change in Body composition Baseline, 10-Week Follow-Up, 24-Week Follow-Up The measurement of body fat in relation to lean body mass will be measured using bio-electrical impedance.
Change in Physical activity enjoyment Baseline, 10-Week Follow-Up, 24-Week Follow-Up 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.
Change in Sedentary Time Baseline, 10-Week Follow-Up, 24-Week Follow-Up Measured by Actigraph accelerometer, in minutes per day.
Change in Negative Affect Baseline, 10-Week Follow-Up, 24-Week Follow-Up 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.
Change in Body Image Baseline, 10-Week Follow-Up, 24-Week Follow-Up Body image will be assessed using the Multidimensional Body-Self Relations Questionnaire (MBSRQ). Higher scores indicate better body image.
Change in Bariatric Surgery-specific Diet and Vitamin Adherence Baseline, 10-Week Follow-Up, 24-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.
Change in Aerobic capacity and endurance Baseline, 10-Week Follow-Up, 24-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 Social support for eating habits Baseline, 10-Week Follow-Up, 24-Week Follow-Up 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.
Change in Moderate to Vigorous Physical Activity (MVPA) Baseline, 10-Week Follow-Up, 24-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/day.
Change in General Self-Efficacy Baseline, 10-Week Follow-Up, 24-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.
Change in Waist circumference (in centimeters) Baseline, 10-Week Follow-Up, 24-Week Follow-Up Waist circumference will be measured by a nurse.
Change in Lipids Baseline, 10-Week Follow-Up, 24-Week Follow-Up Lipids will be measured via blood draw.
Change in Inflammation Baseline, 10-Week Follow-Up, 24-Week Follow-Up C-reactive protein will be measured via blood draw as a measure of inflammation.
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States