Microclinic Social Network Behavioral Health Trial for Obesity and Metabolic Risk Factor Control in Jordan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 914
- 试验地点
- 3
- 主要终点
- Longitudinal change in body weight across all trial arms, over entire study
研究概览
简要总结
This 3-armed randomized controlled trial aims to evaluate the effectiveness of The Microclinic Behavioral Health Program in improving obesity and diabetes risk factors through a behavioral intervention program structured to enhance and promote social-network interactions and social support. The full version of the Microclinic Behavioral Health Program (Full MCP) with program-activated social-network interactions-with shared access to diabetes education, technology, and group support to promote weight and metabolic control through diet, exercise, medication adherence, and blood pressure management. Participants play a role in the collective effort to combat diabetes and solidifying self-management behavioral skills through peer-monitoring and encouragement of lifestyle behaviors. The study may yield valuable information on the impact of social support and social network interactions for enhancing body weight and blood sugar control. We compare the full MCP intervention, to a basic MCP intervention with more limited classroom interaction, and to an parallel monitoring control arm. And we aim to understand how metabolic changes over time relate to the cross-propagation of health behaviors between persons in social networks.
This Microclinic Behavioral Health Program was established in collaboration with the Royal Health Awareness Society (RHAS) and the Jordanian Ministry of Health (MoH).
详细描述
I. Objectives
Because social network-based programs have shown promise as a viable public health intervention strategy, we designed the MCP program to leverage existing social relationships to propagate positive health behaviors in efforts to prevent and manage obesity and diabetes. We conduct a trial to examine the effectiveness of the Microclinic Behavioral Health Program via 3 arm trial in Jordan of a 6 month intervention with 2 years followup.
Furthermore, we aim to uncover the social mechanism of the intervention -- notably to define the pathways through which the social network behavioral health program worked by partitioning the different social network processes of direct causal induction (i.e. change catalyzed by a social network) from homophilly (i.e. where social networks are formed based on similar health behaviors), and confounding (i.e. correlation with exogenous shared variable). Notably, we seek to determine the presence of the amplification of metabolic changes over time due to the cross-propagation of health behaviors between persons in a social network.
II. Study Design
Randomized Control Study: This study is a randomized control study of adults (>= 18 years old) with Type 2 diabetes mellitus, pre-diabetes, or at risk for diabetes, who will be randomly assigned to an intervention group consisting of the Microclinic Behavioral Health Enhanced Program (Group A), a group who will receive the Microclinic Behavioral Health Basic Program without the social network components (Group B) , and controls receiving standard care and risk factor monitoring (Group C).
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
- •diagnosed with type 2 diabetes, pre-diabetes, or 'at-risk for diabetes' (defined below)
- •live in the catchment area of the study
- •provide informed consent to participate.
排除标准
- •participants who are not diagnosed with type 2 diabetes, pre-diabetes, or 'at-risk for diabetes'
- •are not able to provide informed consent due to mental illness
- •women who are pregnant.
- •Pregnant women may participate in consultation with their physician. However, data related to their participation in the trial will not be included in data analysis.
- •'At-risk of diabetes' is defined as either: a) having a history of diabetes in close family AND being overweight/obese, or b) having a family history of diabetes AND having either high BP or high serum cholesterol.
结局指标
主要结局
Longitudinal change in body weight across all trial arms, over entire study
时间窗: Overall change across baseline, to 6 months, to 2 years
Change in body weight from baseline, a joint test of differences across all trial arms
Longitudinal change in glycosylated hemoglobin (HbA1c) across all trial arms, over entire study
时间窗: Overall change across baseline, to 6 months, to 2 years
Change in HbA1c from baseline, a joint test of differences across all trial arms
Longitudinal change in fasting blood glucose across all trial arms, over entire study
时间窗: Overall change across baseline, to 6 months, to 2 years
Change in fasting blood glucose from baseline, a joint test of differences across all trial arms
Longitudinal change in blood pressure across all trial arms, over entire study
时间窗: Overall change across baseline, to 6 months, to 2 years
Change in mean arterial pressure (indexed from systolic and diastolic blood pressure) from baseline, a joint test of differences across all trial arms. mean arterial pressure was calculated using the clinical formula MAP=(SBP + (2\*DBP))/3)
Temporally investigate the causal induction of cascading changes in body weight between follow-ups on subsequent weight changes in other participants.
时间窗: Change from each session (weekly, biweekly, triweekly), on each subsequent session, during 6 month intervention period.
Using time intervals between follow-ups analyzed as separate induction timeframe windows, we estimate how weight loss observed in a previous time window predicts body weight change in subsequent followup intervals of the other participants.
次要结局
- Relative changes in body weight between individual trial arms(Change from baseline, at 6 months, at 2 years)
- Relative changes in HbA1c between individual trial arms(Change from baseline, at 6 months, at 2 years)
- Relative changes in blood pressure between individual trial arms(Change from baseline, at 6 months, at 2 years)
- Relative changes in fasting glucose between individual trial arms(Change from baseline, at 6 months, at 2 years)