Comparison of Two Approaches for Improving Long-term Weight Loss Among Individuals With Severe Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Recruitment feasibility will be assessed by the number of participants screened and enrolled
研究概览
简要总结
The purpose of this study is to examine the feasibility of two approaches for improving long-term weight loss success among individuals with severe obesity. All participants will receive a 15-week, standard behavioral weight loss program followed by either 8 weeks of a mindfulness self-compassion intervention or 8 weeks of a nutrition and cooking education intervention (determined via randomization procedures). Assessments of weight, physical activity, and other weight-related and psychosocial factors will occur at baseline, 4 months, 6 months, and 9 months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years
- •BMI between 40 - 55 kg/m2
- •Score high on internalized weight bias
排除标准
- •Presence of any condition that would limit one's ability to exercise (i.e., orthopedic limitations)
- •Recent weight loss (≥15 pounds within the past 6 months)
- •History of bariatric surgery
- •Current or recent enrollment (completed <1 year ago) in a weight loss program at the Weight Control and Diabetes Research Center
- •Currently taking any weight loss or other medication that could alter one's metabolism
- •Women who are pregnant, planning on becoming pregnant in the next 6 months, or those pregnant within the past 6 months
- •Serious psychiatric disorder (e.g., psychosis, major depression, suicidality) -
- •Participants with a history of diabetes or heart disease will be considered for this study only if their heart disease or diabetes is well controlled, and physician consent will be required.
研究组 & 干预措施
Weight loss and self-compassion
Participants will receive a 15-week behavioral weight loss program which teaches strategies for changing diet and exercise behaviors. This will consist of a combination of group and individual sessions. Group classes will be delivered remotely via a video-conferencing platform. This will be followed by an 8-week mindfulness-based self-compassion program which combines the skills of mindfulness and self-compassion as a means for improving emotional resilience, well-being, and weight control.
干预措施: Behavioral weight loss program (Behavioral)
Weight loss and self-compassion
Participants will receive a 15-week behavioral weight loss program which teaches strategies for changing diet and exercise behaviors. This will consist of a combination of group and individual sessions. Group classes will be delivered remotely via a video-conferencing platform. This will be followed by an 8-week mindfulness-based self-compassion program which combines the skills of mindfulness and self-compassion as a means for improving emotional resilience, well-being, and weight control.
干预措施: Self-compassion (Behavioral)
Weight loss and nutrition/cooking education
Participants will receive a 15-week behavioral weight loss program which teaches strategies for changing diet and exercise behaviors. This will consist of a combination of group and individual sessions. Group classes will be delivered remotely via a video-conferencing platform. This will be followed by an 8-week nutrition and cooking education program which will provide basic nutrition knowledge and cooking skills for healthy eating.
干预措施: Behavioral weight loss program (Behavioral)
Weight loss and nutrition/cooking education
Participants will receive a 15-week behavioral weight loss program which teaches strategies for changing diet and exercise behaviors. This will consist of a combination of group and individual sessions. Group classes will be delivered remotely via a video-conferencing platform. This will be followed by an 8-week nutrition and cooking education program which will provide basic nutrition knowledge and cooking skills for healthy eating.
干预措施: Nutrition and cooking education (Behavioral)
结局指标
主要结局
Recruitment feasibility will be assessed by the number of participants screened and enrolled
时间窗: At the end of the study, up to 9 months post-baseline
Recruitment feasibility will be assessed by the number of participants screened and enrolled
Session attendance will be assessed by calculating the overall session attendance (# of sessions completed/# of sessions possible).
时间窗: 6 months
The feasibility of the intervention will be assessed by calculating the overall session attendance
Acceptability of the intervention (retention) will be determined by the percentage of participants completing the 9-month assessment visit
时间窗: 9 months
Acceptability of the intervention (retention) will be determined by the percentage of participants completing the 9-month assessment visit
次要结局
- Percent weight change at 6 months(6 months after study enrollment)
- Percent weight change at 9 months(9 months after study enrollment)
研究者
Jessica Unick
Assistant Professor (Research)
The Miriam Hospital