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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Behavioral Lifestyle Change, Social Change, Diabetes Mellitus, Type II, Overweight and Obesity, Hypertension

Intervention / Treatment
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* Behavioral: Microclinic Social Induction Diabetes and Obesity Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microclinic social induction training<br>BMI of 30 and over; or BMI of 25 and over and self-reported pre-diabetes or type II diabetes will receive the Microclinic Social Induction Diabetes and Obesity Program. The intervention is a training on diabetes self-management, disease monitoring, diabetes prevention, prevention of complications, health behavior change, and social network supports in order to improve chronic disease risk factors. | Behavioral: Microclinic Social Induction Diabetes and Obesity Program<br>* Microclinics consist of 2-8 individuals from pre-existing social networks (friends, relatives, coworkers, neighbors, etc) that voluntarily participate in ongoing education and medical monitoring from local health care professionals, learning and practicing diabetes management strategies, sharing much-needed medical supplies, and exchanging social support.<br>|
| No Intervention: Controls<br>Receiving no intervention but parallel primary and secondary outcome measures as intervention study arm | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Change in body weight (and BMI) | Weekly measurements between baseline and end of trial after 7 weeks | 
| HbA1c | Change in HbA1c from baseline to end of 7-week pilot phase. | Baseline, end of trial after 7 weeks | 
| Waist circumference |  | Baseline, 4th-week midpoint, 7th-week final | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Systolic and diastolic blood pressure changes | Baseline, 4th-week midpoint, 7th-week final | 
| Health Profile Survey | Change in overall health seeking and health maintenance behaviors. | Baseline, end of trial after 7 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type II, Disease management, Obesity, Social Network, Chronic disease, Prevention and control, Education