Clinical trial NCT02175537: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Microclinic International
Sponsor class: OTHER
Collaborators: name: Qatar University
name: Qatar Foundation
name: Qatar Diabetes Association
name: Qatar Supreme Council of Health
name: Harvard School of Public Health (HSPH)
First posted: 2014-06-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Weight
timeFrame: Weekly measurements between baseline and end of trial after 7 weeks
measure: HbA1c
timeFrame: Baseline, end of trial after 7 weeks
measure: Waist circumference
timeFrame: Baseline, 4th-week midpoint, 7th-week final
Secondary outcomes:
measure: Blood Pressure
timeFrame: Baseline, 4th-week midpoint, 7th-week final
measure: Health Profile Survey
timeFrame: Baseline, end of trial after 7 weeks.
Other outcomes:
measure: Social Network Relationships
timeFrame: Baseline, end of trial after 7 weeks.
Locations:
city: Doha
country: Qatar
facility: Qatar Diabetes Association
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Eric L Ding, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Microclinic International
name: Daniel Zoughbie, DPhil
role: PRINCIPAL_INVESTIGATOR
References: