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

December 18, 2014 updated by: Microclinic International
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Qatar
      • Doha, Qatar
        • Qatar Diabetes Association

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microclinic social induction training
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
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.
No Intervention: Controls
Receiving no intervention but parallel primary and secondary outcome measures as intervention study arm

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social Network Relationships
Time Frame: Baseline, end of trial after 7 weeks.
Changes in degree of interpersonal health support relationships as assess on Social Network Matrix instrument
Baseline, end of trial after 7 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Microclinic International

Collaborators

Harvard School of Public Health (HSPH)
Qatar University
Qatar Foundation
Qatar Diabetes Association
Qatar Supreme Council of Health

Investigators

  • Principal Investigator: Daniel Zoughbie, DPhil, Microclinic International
  • Principal Investigator: Eric L Ding, PhD, Harvard School of Public Health (HSPH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

June 18, 2014

First Submitted That Met QC Criteria

June 25, 2014

First Posted (Estimate)

June 26, 2014

Study Record Updates

Last Update Posted (Estimate)

December 19, 2014

Last Update Submitted That Met QC Criteria

December 18, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPRP2014-2017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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