Bariatric Surgery
Conditions
Keywords
Positive Psychology, Motivational Interviewing, Physical Activity
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.
Interventions
BEHAVIORALPositive 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.
BEHAVIORALPhysical 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.
Sponsors
Massachusetts General Hospital
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
A research assistant blinded to study condition will conduct follow-up assessment visits.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. * Severe psychiatric condition limiting ability to participate (e.g., psychosis, active substance use disorder)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Intervention Acceptability | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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/week. |
| 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 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 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 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 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 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. The range for total scores is 10-40 with higher scores indicate greater self-efficacy. Mean total scores are reported. |
| 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 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: 1-7). Higher scores indicate greater internalized weight bias. |
| 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. The range of scores is 0-66 with higher scores indicating better adherence to diet and vitamin recommendations. Mean total scores are reported. |
| 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 Mass Index | 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. |
| Change in Systolic Blood Pressure (Millimeters of Mercury) | Baseline, 10-Week Follow-Up, 24-Week Follow-Up | Blood pressure will be measured by a nurse. |
| 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 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 A1C | Baseline, 10-Week Follow-Up, 24-Week Follow-Up | Hemoglobin A1C will be measured via blood draw. |
| Change in HDL Cholesterol | Baseline, 10-Week Follow-Up, 24-Week Follow-Up | Lipids (HDL, LDL, Triglyceride) 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. |
| 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. The range of total scores is 18-126 with higher scores indicating greater enjoyment during exercise. Mean total scores are reported. |
| Change in Diastolic Blood Pressure (Millimeters of Mercury) | Baseline, 10-Week Follow-Up, 24-Week Follow-Up | Blood pressure will be measured by a nurse. |
| Change in LDL Cholesterol | Baseline, 10-Week Follow-Up, 24-Week Follow-Up | Lipids (HDL, LDL, Triglyceride) will be measured via blood draw. |
| Change in Triglycerides | Baseline, 10-Week Follow-Up, 24-Week Follow-Up | Lipids (HDL, LDL, Triglyceride) will be measured via blood draw. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREmily H Feig, PhD
Massachusetts General Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 43.34 years STANDARD_DEVIATION 10.14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 35 Participants |
| Region of Enrollment United States | 58 Participants |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 29 | 0 / 29 |
| other Total, other adverse events | 1 / 29 | 3 / 29 |
| serious Total, serious adverse events | 2 / 29 | 0 / 29 |
Outcome results
None listed