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临床试验/NCT02175537
NCT02175537已完成不适用

Microclinic Social Induction Pilot Intervention for Diabetes and Obesity Management in Qatar

Microclinic International1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Waist circumference

研究概览

简要总结

The purpose of the study is to pilot-phase test the effectiveness of the microclinic social induction model and its effects on behavioral and metabolic outcomes in different levels of social and familial relationships in Qatar. The investigators novel microclinic model is based on the principle that both healthy and unhealthy behaviors spread through preexisting social networks. A microclinic is a small group of approximately 2-8 friends or family members who are taught to modify their own behaviors as well as the behaviors of those around them, with a particular focus on the four "M's": Meals, Movement, Monitoring, and Medication. More than social support groups or peer-to-peer interventions, the microclinic model is unique in its focus on the long-term propagation of healthy behaviors throughout a participant's entire social network. Qatar is uniquely positioned (with its central geographic location in the Gulf region and its leadership in science and education) to spearhead a regional intervention focused on managing and preventing diabetes in the Gulf region.

详细描述

This pilot study, "Microclinic Social Induction Intervention for Diabetes and Obesity Management in Qatar," is a two-arm randomized controlled trial of a 7-week condensed intervention to evaluate the efficacy of the microclinic social induction model on propagating lifestyle changes and in improving glycemic and metabolic control in Doha, Qatar.

The microclinic social induction model leverages different levels of social and familial relationships to positively influence behaviors relating to diabetes and other metabolic conditions through small treatment units called 'microclinic groups,' consisting of 2-8 peers and family members of the same social network. The intervention model brings microclinic groups to a larger classroom network (~25 people/class) where each class shares access to a culturally salient diabetes educational curriculum and group support to promote health behavior changes such as improvement in diet, exercise, medication adherence, and blood pressure management to then influence better glycemic and metabolic control.

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

入选标准

  • Over 18 years old
  • Mentally competent
  • Body Mass Index of 30 or higher
  • Body Mass Index of 25 or higher and self-reported pre-diabetes or type II diabetes

排除标准

  • They do not meet the above criteria
  • They are pregnant
  • They have significant medical complications that prevent them from making changes to diet or level of physical activity.

结局指标

主要结局

Waist circumference

时间窗: Baseline, 4th-week midpoint, 7th-week final

Weight

时间窗: Weekly measurements between baseline and end of trial after 7 weeks

Change in body weight (and BMI)

HbA1c

时间窗: Baseline, end of trial after 7 weeks

Change in HbA1c from baseline to end of 7-week pilot phase.

次要结局

  • Blood Pressure(Baseline, 4th-week midpoint, 7th-week final)
  • Health Profile Survey(Baseline, end of trial after 7 weeks.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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