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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02175537
• Other study ID #: NPRP2014-2017
• Status: Completed
• Phase: N/A
• First received: June 18, 2014
• Last updated: December 18, 2014
• Start date: June 2014
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: Microclinic International
• Contact: n/a
• Is FDA regulated: No
• Health authority: Qatar University: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Behavioral Lifestyle Change
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II
• Hypertension
• Obesity
• Overweight and Obesity
• Social Change

Intervention

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.

Locations

Country	Name	City	State
Qatar	Qatar Diabetes Association	Doha

Sponsors (6)

Lead Sponsor	Collaborator
Microclinic International	Harvard School of Public Health, Qatar Diabetes Association, Qatar Foundation, Qatar Supreme Council of Health, Qatar University

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Social Network Relationships	Changes in degree of interpersonal health support relationships as assess on Social Network Matrix instrument	Baseline, end of trial after 7 weeks.	No
Primary	Weight	Change in body weight (and BMI)	Weekly measurements between baseline and end of trial after 7 weeks	No
Primary	HbA1c	Change in HbA1c from baseline to end of 7-week pilot phase.	Baseline, end of trial after 7 weeks	No
Primary	Waist circumference		Baseline, 4th-week midpoint, 7th-week final	No
Secondary	Blood Pressure	Systolic and diastolic blood pressure changes	Baseline, 4th-week midpoint, 7th-week final	No
Secondary	Health Profile Survey	Change in overall health seeking and health maintenance behaviors.	Baseline, end of trial after 7 weeks.	No

External Links

•   Related info on Microclinic International