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

NCT02175537 | Completed

• 1 other identifier: NPRP2014-2017
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Blood Pressure

  Baseline, 4th-week midpoint, 7th-week final

• Health Profile Survey

  Baseline, end of trial after 7 weeks.

Other Outcomes (1)

• Social Network Relationships

  Baseline, end of trial after 7 weeks.

Study Arms (2)

Microclinic social induction training

EXPERIMENTAL

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

Controls

NO INTERVENTION

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

Interventions

Microclinic Social Induction Diabetes and Obesity Program BEHAVIORAL

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.

Microclinic social induction training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Microclinic International: lead
• Qatar University: collaborator
• Qatar Foundation: collaborator
• Qatar Diabetes Association: collaborator
• Qatar Supreme Council of Health: collaborator
• Harvard School of Public Health (HSPH): collaborator

Study Sites (1)

Qatar Diabetes Association

Doha, Qatar

Location

Related Links

• Related info on Microclinic International

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity; Hypertension; Chronic Disease

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes

Study Officials

• Eric L Ding, PhD

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

• Daniel Zoughbie, DPhil

  Microclinic International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: June 26, 2014
• Study Start: June 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 19, 2014

Record last verified: 2014-12

Locations

QA (1)