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Completed

NCT Number: NCT02175537

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Microclinic International

Other

Collaborators

  • Harvard School of Public Health (HSPH)
  • Qatar Diabetes Association
  • Qatar Foundation
  • Qatar Supreme Council of Health
  • Qatar University

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 26, 2014
Registry last updated
Dec 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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