Micro-Clinic Obesity and Metabolic Risk Prevention Program: A Randomized-Control Trial of a Social-Network Based Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 494
- 试验地点
- 1
- 主要终点
- Weight
研究概览
简要总结
The purpose of this randomized trial is to study the efficacy of a novel social propagation intervention which integrates social network induction with health education for weight and metabolic control among patients with type 2 diabetes, BMI of 25-30+, and cardiovascular disease. The intervention takes place in the form of a community health program, where participants who enroll in this program will be asked if they would like to take part in the study to evaluate its efficacy. Thus, the investigators will study the efficacy of social networks in propagating changes in lifestyle factors for diabetes and chronic disease management
详细描述
The potential to harness the propagating power of social networks for chronic disease treatment and management, such as for diabetes and obesity, is an emerging area in epidemiology and clinical research. Social induction for disease management has been effectively leveraged for disease management, but we have not carefully disaggregated of different layers and modalities of social network effects in this context. This study will test and demonstrate this through a novel randomized trial.
The randomized design is comprised of 2 arms. 1) Intervention Group: This arm takes part in a 10-month (9-month for Phase 2, cycles 1 and 2) diabetes, weight, and cardiovascular disease education and management program in combination with the microclinic social support model. A microclinic is a support group of 2-6 individuals from the same social network who learn how to manage their disease together. 2) Control Group: This is a control arm with observational parallel assessments of metabolic and lifestyle risk factors alone (implemented in Phase 1 and 2, cycles 1 and 2). Each arm will take part in a 6-month follow-up. The investigators also aim to study the intervention effects of social networks in improving lifestyle risk factors on a small sample of Phase 1 controls in a repeated measures design. Observational controls with 7 repeated measures in Phase 1 (pre-intervention) will receive the 9-month diabetes, weight, and cardiovascular disease education and management program with microclinic social support model condensed in a 4-6 months program. The controls in this cycle will also receive 17 medical screenings during the intervention, and 6-month follow-up (post-intervention).
Aim 1- (Phase 1 and 2, Cycles 1 & 2)
To evaluate the efficacy of the microclinic intervention group versus observational control in improving lifestyle factors and metabolic outcome.
Aim 2- (Phase 2, Cycle 3)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Must be enrolled in our community health program.
- •Over the age of 18
- •BMI of 30 or higher, or
- •BMI of 25 or higher AND must be diagnosed with at least one additional risk factor 1) type 2 diabetes, 2) high blood pressure, and/or 3) high cholesterol
- •For those who will be participating in the cross-over sub-sample, they must have previously participated in Phase 1 as subject of the control group, or
排除标准
- •Patients who are not enrolled in the our community health education program (applies to Phase 1 only)
- •Are not able to provide informed consent for themselves
- •Under the age of 18
- •Has undergone weight loss surgery
- •Pregnant women*
研究组 & 干预措施
Microclinic Social Network Program
Subjects will be receiving a 10/9-month Microclinic Diabetes Education Program (Team Up 4 Health) and 6 months of follow up. In the intervention these subjects will engage in the Microclinic Program support groups. The intervention program consists of 25 event sessions. Sessions are offered weekly the first month, and biweekly thereafter.
干预措施: Microclinic Diabetes Education Program (Behavioral)
Active Controls
Individuals will receive screening by clinical staff. Control group subjects are offered standard of care from local health department, but will not participate in program activities, other than offered option to join open-community health events.
干预措施: Control (Behavioral)
结局指标
主要结局
Weight
时间窗: From baseline until end of intervention period (9-10 months), and 6 months post-intervention
Change in weight over time
次要结局
- Blood pressure(From baseline until end of intervention period (9-10 months), and 6 months post-intervention)
- HDL(From baseline until end of intervention period (9-10 months), and 6 months post-intervention)
- Hemoglobin A1c (%, HbA1c)(From baseline until end of intervention period (9-10 months), and 6 months post-intervention)
- Waist circumference(From baseline until end of intervention period (9-10 months), and 6 months post-intervention)