Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT04868032
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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.
Time frame: 10 weeks
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.
Time frame: 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/week.
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Measured by Actigraph accelerometer, in number of steps per day.
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Measured by Actigraph accelerometer, in minutes per day.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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. The range for total scores is 10-40 with higher scores indicate greater self-efficacy. Mean total scores are reported.
Time frame: 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.
Time frame: 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: 1-7). Higher scores indicate greater internalized weight bias.
Time frame: 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. The range of scores is 0-66 with higher scores indicating better adherence to diet and vitamin recommendations. Mean total scores are reported.
Time frame: 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.
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Body mass index (kilograms/meters squared) will be calculated with body weight and height measured on a calibrated scale.
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Blood pressure will be measured by a nurse.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Hemoglobin A1C will be measured via blood draw.
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Lipids (HDL, LDL, Triglyceride) will be measured via blood draw.
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
C-reactive protein will be measured via blood draw as a measure of inflammation.
Time frame: 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. The range of total scores is 18-126 with higher scores indicating greater enjoyment during exercise. Mean total scores are reported.
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Blood pressure will be measured by a nurse.
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Lipids (HDL, LDL, Triglyceride) will be measured via blood draw.
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Lipids (HDL, LDL, Triglyceride) will be measured via blood draw.
Massachusetts General Hospital
Other
Gaining Optimism After Weight Loss Surgery (GOALS) II: Randomized Controlled Trial of a Positive Psychology-based Intervention to Increase Physical Activity After Bariatric Surgery
Acronym: GOALS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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