Gaining Optimism After Weight Loss Surgery (GOALS) II: Randomized Controlled Trial of a Positive Psychology-based Intervention to Increase Physical Activity After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Number of Intervention Sessions Completed
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
A research assistant blinded to study condition will conduct follow-up assessment visits.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Positive Psychology-Motivational Interviewing (Behavioral)
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.
干预措施: Physical Activity Education Control (Behavioral)
结局指标
主要结局
Number of Intervention Sessions Completed
时间窗: 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
时间窗: 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.
次要结局
- Change in Moderate to Vigorous Physical Activity (MVPA)(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in General Self-Efficacy(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Internalized Weight Bias(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Bariatric Surgery-specific Diet and Vitamin Adherence(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Steps(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Light Physical Activity(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Anxiety(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Exercise Identity(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Self-Reported Physical Activity(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in A1C(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Positive Affect(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Optimism(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Exercise-specific Self-efficacy(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Inflammation(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in HDL Cholesterol(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Depressive Symptoms(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Body Mass Index(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Systolic Blood Pressure (Millimeters of Mercury)(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Aerobic Capacity and Endurance(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Body Composition(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Physical Activity Enjoyment(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Diastolic Blood Pressure (Millimeters of Mercury)(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in LDL Cholesterol(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
- Change in Triglycerides(Baseline, 10-Week Follow-Up, 24-Week Follow-Up)
研究者
Emily Feig, Ph.D.
Instructor in Psychology
Massachusetts General Hospital