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

Primary Purpose

Diabetes Mellitus, Type II, Overweight and Obesity, Hypertension

Status
Completed
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
Microclinic Social Induction Diabetes and Obesity Program
Sponsored by
Microclinic International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type II focused on measuring Diabetes Mellitus, Type II, Disease management, Obesity, Social Network, Chronic disease, Prevention and control, Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Qatar Diabetes Association

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Microclinic social induction training

Controls

Arm Description

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.

Receiving no intervention but parallel primary and secondary outcome measures as intervention study arm

Outcomes

Primary Outcome Measures

Weight
Change in body weight (and BMI)
HbA1c
Change in HbA1c from baseline to end of 7-week pilot phase.
Waist circumference

Secondary Outcome Measures

Blood Pressure
Systolic and diastolic blood pressure changes
Health Profile Survey
Change in overall health seeking and health maintenance behaviors.

Full Information

First Posted
June 18, 2014
Last Updated
December 18, 2014
Sponsor
Microclinic International
Collaborators
Qatar University, Qatar Foundation, Qatar Diabetes Association, Qatar Supreme Council of Health, Harvard School of Public Health (HSPH)
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1. Study Identification

Unique Protocol Identification Number
NCT02175537
Brief Title
Microclinic Social Induction Pilot Intervention for Diabetes and Obesity Management in Qatar
Official Title
Microclinic Social Induction Pilot Intervention for Diabetes and Obesity Management in Qatar
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Microclinic International
Collaborators
Qatar University, Qatar Foundation, Qatar Diabetes Association, Qatar Supreme Council of Health, Harvard School of Public Health (HSPH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type II, Overweight and Obesity, Hypertension, Behavioral Lifestyle Change, Social Change
Keywords
Diabetes Mellitus, Type II, Disease management, Obesity, Social Network, Chronic disease, Prevention and control, Education

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Microclinic social induction training
Arm Type
Experimental
Arm Description
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.
Arm Title
Controls
Arm Type
No Intervention
Arm Description
Receiving no intervention but parallel primary and secondary outcome measures as intervention study arm
Intervention Type
Behavioral
Intervention Name(s)
Microclinic Social Induction Diabetes and Obesity Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight
Description
Change in body weight (and BMI)
Time Frame
Weekly measurements between baseline and end of trial after 7 weeks
Title
HbA1c
Description
Change in HbA1c from baseline to end of 7-week pilot phase.
Time Frame
Baseline, end of trial after 7 weeks
Title
Waist circumference
Time Frame
Baseline, 4th-week midpoint, 7th-week final
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
Systolic and diastolic blood pressure changes
Time Frame
Baseline, 4th-week midpoint, 7th-week final
Title
Health Profile Survey
Description
Change in overall health seeking and health maintenance behaviors.
Time Frame
Baseline, end of trial after 7 weeks.
Other Pre-specified Outcome Measures:
Title
Social Network Relationships
Description
Changes in degree of interpersonal health support relationships as assess on Social Network Matrix instrument
Time Frame
Baseline, end of trial after 7 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric L Ding, PhD
Organizational Affiliation
Harvard School of Public Health (HSPH)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Zoughbie, DPhil
Organizational Affiliation
Microclinic International
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qatar Diabetes Association
City
Doha
Country
Qatar

12. IPD Sharing Statement

Links:
URL
http://www.microclinics.org/
Description
Related info on Microclinic International

Learn more about this trial

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

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