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

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ClinicalTrials.gov Identifier: NCT02175537
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : December 19, 2014
Sponsor:
Collaborators:
Qatar University
Qatar Foundation
Qatar Diabetes Association
Qatar Supreme Council of Health
Harvard School of Public Health
Information provided by (Responsible Party):
Microclinic International

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type II Overweight and Obesity Hypertension Behavioral Lifestyle Change Social Change Behavioral: Microclinic Social Induction Diabetes and Obesity Program Not Applicable

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  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Microclinic Social Induction Pilot Intervention for Diabetes and Obesity Management in Qatar
Study Start Date : June 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

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



Primary Outcome Measures :
  1. Weight [ Time Frame: Weekly measurements between baseline and end of trial after 7 weeks ]
    Change in body weight (and BMI)

  2. HbA1c [ Time Frame: Baseline, end of trial after 7 weeks ]
    Change in HbA1c from baseline to end of 7-week pilot phase.

  3. Waist circumference [ Time Frame: Baseline, 4th-week midpoint, 7th-week final ]

Secondary Outcome Measures :
  1. Blood Pressure [ Time Frame: Baseline, 4th-week midpoint, 7th-week final ]
    Systolic and diastolic blood pressure changes

  2. Health Profile Survey [ Time Frame: Baseline, end of trial after 7 weeks. ]
    Change in overall health seeking and health maintenance behaviors.


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175537


Locations
Qatar
Qatar Diabetes Association
Doha, Qatar
Sponsors and Collaborators
Microclinic International
Qatar University
Qatar Foundation
Qatar Diabetes Association
Qatar Supreme Council of Health
Harvard School of Public Health
Investigators
Principal Investigator: Eric L Ding, PhD Harvard School of Public Health
Principal Investigator: Daniel Zoughbie, DPhil Microclinic International

Additional Information:
Responsible Party: Microclinic International
ClinicalTrials.gov Identifier: NCT02175537     History of Changes
Other Study ID Numbers: NPRP2014-2017
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014

Keywords provided by Microclinic International:
Diabetes Mellitus, Type II
Disease management
Obesity
Social Network
Chronic disease
Prevention and control
Education

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Overweight
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms