Reducing Obesity Using Social Ties (ROBUST): Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Number of intervention participants who have at least one social network member engage in the study
研究概览
简要总结
This trial aims to test the feasibility and acceptability of addressing interpersonal barriers to weight-related behavior change. Specifically, the study will test if, by including up to two friends, family members, or co-workers in a lifestyle intervention for weight loss, the person enrolled in the study loses more weight than someone whose friends, family members, or co-workers were not invited to participate.
详细描述
The investigators will evaluate whether the ROBUST intervention not only addresses individual-level behaviors (i.e., healthy eating, increased physical activity) but also:
- reduces social undermining as well as changes perceived health norms by activating communal coping - a behavioral process that involves thinking, communicating, and acting as if a health risk (i.e., Type 2 diabetes) is shared; and
- dampens the harmful effects of increased interpersonal conflict on weight by teaching participants how to induce a positive affect and self-affirming mindset
Participants in the control arm will receive the same number of lifestyle sessions as those randomized to the social network intervention.
Participants will:
- Be randomly assigned to either the study group, which is asked to invite up to two friends or family members to join them at three coaching sessions, or the group that does not invite anyone.
- Receive 15 coaching sessions over 24 weeks.
- Complete an online questionnaire about eating and physical activity habits, confidence in developing healthier habits, mood, and health habits of twelve of their closest friends and family members.
- Complete a 3-day weekly food log and wear a provided Fitbit for at least 9 hours daily.
- The invited friends and family members will also be asked to complete a brief questionnaire about their eating and physical activity habits when they start and end the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Index Participant:
- •Black race or Hispanic ethnicity
- •Male or Female 18 years of age or older
- •Calculated BMI > 30kg/m2 from objectively measured height and weight by study staff
- •Access & willingness to use program food intake app via home computer or a smartphone
- •Ability to identify at least one adult social network member who will participate in the study
- •Social Network Member:
- •Male or Female 18 years of age or older
- •Access to the internet or a smartphone
排除标准
- •Index Participant:
- •Active enrollment in a weight-loss program, use of weight-loss medications, or planning weight-loss surgery
- •Advanced medical illness, dementia, hospitalization, injury, or pregnancy that inhibits regular physical activity
- •Contraindications to exercise based on the Physical Activity Readiness Questionnaire or lack of clearance from a health care provider
- •Unresolved Food insecurity
- •Speaks a language other than English or Spanish
- •Social Network Member:
- •Speaks a language other than English or Spanish
研究组 & 干预措施
Social Network Intervention
Participants will complete 3 communication skills sessions with their social network members during weeks 3, 5, and 15.
干预措施: Social Network Intervention (Behavioral)
Individual Lifestyle Intervention
Participants will complete standard diabetes prevention program (DPP) based health coaching sessions during weeks 3, 5, and 15.
干预措施: Individual Lifestyle Intervention (Behavioral)
Social Network Member
Social Network Members will complete 3 communication skills sessions with the social network intervention participant during weeks 3, 5, and 15.
干预措施: Social Network Member (Other)
结局指标
主要结局
Number of intervention participants who have at least one social network member engage in the study
时间窗: End of Study (24 weeks)
Number of participants who have attended at least 75 percent of the behavioral coaching sessions
时间窗: End of study (24 weeks)
Number of participants and social network members combined who complete the final study assessment
时间窗: End of Study (24 Weeks)
次要结局
- Change in median Fitbit wear time in minutes(Weekly up to 24 weeks)
- Change in positive communication and problem solving as measured by the McMaster Family Assessment Device (FAD) Questionnaire(Baseline, End of Study (24 weeks))
- Change in weight related social norms(Baseline, End of Study (24 weeks))
- Change in median number of days that the Fitbit is worn(Weekly up to 24 weeks)
- Change in total caloric amounts on three-day food record(Weekly up to 24 weeks)