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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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.
Massachusetts General Hospital
Boston, Massachusetts, United States
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.
Time frame: 10 weeks
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.
Time frame: 10 weeks
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.
Time frame: Baseline and 10-Week Follow-Up
Change in Steps
Measured by Actigraph accelerometer, in number of steps per day.
Time frame: Baseline and 10-Week Follow-Up
Change in Light Physical Activity
Measured by Actigraph accelerometer, in minutes per week.
Time frame: Baseline and 10-Week Follow-Up
Change in Sedentary Time
Measured by Actigraph accelerometer, in minutes per day.
Time frame: Baseline and 10-Week Follow-Up
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.
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Time frame: Baseline and 10-Week Follow-Up
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.
Time frame: Baseline and 10-Week Follow-Up
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.
Time frame: Baseline and 10-Week Follow-Up
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.
Time frame: Baseline and 10-Week Follow-Up
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.
Time frame: Baseline and 10-Week Follow-Up
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.
Time frame: Baseline and 10-Week Follow-Up
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.
Time frame: Baseline and 10-Week Follow-Up
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.
Time frame: Baseline and 10-Week Follow-Up
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.
Time frame: Baseline and 10-Week Follow-Up
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.
Time frame: Baseline and 10-Week Follow-Up
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.
Time frame: Baseline and 10-Week Follow-Up
Change in Body Weight
Body weight (in pounds) will be measured on a calibrated scale.
Time frame: Baseline and 10-Week Follow-Up
Change in Waist Circumference (in Centimeters)
Waist circumference will be measured by a nurse.
Time frame: Baseline and 10-Week Follow-Up
Change in Systolic Blood Pressure
Blood pressure will be measured by a nurse in mmHG.
Time frame: Baseline and 10-Week Follow-Up
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.
Time frame: Baseline and 10-Week Follow-Up
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.
Time frame: Baseline and 10-Week Follow-Up
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.
Time frame: Baseline and 10-Week Follow-Up
Change in Body Composition
The measurement of body fat in relation to lean body mass will be measured using bio-electrical impedance.
Time frame: Baseline and 10-Week Follow-Up
Change in A1C
Hemoglobin A1C will be measured via blood draw. A higher percentage means higher blood glucose values.
Time frame: Baseline and 10-Week Follow-Up
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.
Time frame: Baseline and 10-Week Follow-Up
Change in Inflammation
C-reactive protein will be measured via blood draw as a measure of inflammation in mg/dL.
Time frame: Baseline and 10-Week Follow-Up