Micro-Clinic Obesity and Metabolic Risk Prevention Program
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|ClinicalTrials.gov Identifier: NCT01651065|
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : March 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type II Heart Disease Obesity Hypertension Dyslipidemia||Behavioral: Microclinic Diabetes Education Program Behavioral: Control||Not Applicable|
The potential to harness the propagating power of social networks for chronic disease treatment and management, such as for diabetes and obesity, is an emerging area in epidemiology and clinical research. Social induction for disease management has been effectively leveraged for disease management, but we have not carefully disaggregated of different layers and modalities of social network effects in this context. This study will test and demonstrate this through a novel randomized trial.
The randomized design is comprised of 2 arms. 1) Intervention Group: This arm takes part in a 10-month (9-month for Phase 2, cycles 1 and 2) diabetes, weight, and cardiovascular disease education and management program in combination with the microclinic social support model. A microclinic is a support group of 2-6 individuals from the same social network who learn how to manage their disease together. 2) Control Group: This is a control arm with observational parallel assessments of metabolic and lifestyle risk factors alone (implemented in Phase 1 and 2, cycles 1 and 2). Each arm will take part in a 6-month follow-up. The investigators also aim to study the intervention effects of social networks in improving lifestyle risk factors on a small sample of Phase 1 controls in a repeated measures design. Observational controls with 7 repeated measures in Phase 1 (pre-intervention) will receive the 9-month diabetes, weight, and cardiovascular disease education and management program with microclinic social support model condensed in a 4-6 months program. The controls in this cycle will also receive 17 medical screenings during the intervention, and 6-month follow-up (post-intervention).
Aim 1- (Phase 1 and 2, Cycles 1 & 2)
To evaluate the efficacy of the microclinic intervention group versus observational control in improving lifestyle factors and metabolic outcome.
Aim 2— (Phase 2, Cycle 3)
To examine the effect of the microclinic intervention by comparing pre- and post measures among those who were first controls in Phase 1 and then participated in the microclinic intervention Phase 2, Cycle 3.
AIM 3— (Phases 1 & 2, cycles 1, 2, and 3)
To differentiate the modalities of social network effects: direct causal induction versus homophilly, and to determine the extent of long-term temporal cross-propagating effects between-persons in a microclinic group.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||919 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Micro-Clinic Obesity and Metabolic Risk Prevention Program: A Randomized-Control Trial of a Social-Network Based Intervention|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Microclinics Group A
Subjects will be receiving a 10/9-month Microclinic Diabetes Education Program (Team Up 4 Health) and 6 months of follow up. In the intervention these subjects will engage in the Microclinic Program support groups. The intervention program consists of 25 event sessions. Sessions are offered weekly the first month, and biweekly thereafter.
Behavioral: Microclinic Diabetes Education Program
The microclinic intervention leverages different levels of social networks to positively influence behaviors relating to diabetes and other metabolic conditions through small treatment units called, 'microclinic groups (MC),' consisting of 2-6 friends and family members of the same social network, which lead to a larger network of 'classes' and cohorts.
The program provides MC subjects with shared access to health education and group support to promote glycemic and metabolic control through diet, exercise, and treatment adherence. MC members play a role in the collective effort to combat diabetes and solidifying self-management behavioral skills through peer-monitoring and encouragement of lifestyle behaviors.
Placebo Comparator: Group C Controls
Individuals will receive screening by clinical staff. Control group subjects will receive clinic screenings only; they will not participate in program activities.
- Weight [ Time Frame: Seven collected time points from baseline until final session at 10/9 months ]Change in weight overtime
- Waist circumference [ Time Frame: Seven collected time points from baseline until final session at 10/9 months ]Change in waist measurement overtime
- Blood pressure [ Time Frame: Seven collected time points from baseline until final session at 10/9 months ]Change in systolic/diastolic blood pressure overtime
- HDL [ Time Frame: Seven collected time points from baseline until final session at 10/9 months ]Change in HDL overtime
- Hemoglobin A1c (%, HbA1c) [ Time Frame: Seven collected time points from baseline until final session at 10/9 months ]Change in HbA1c overtime
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651065
|United States, Kentucky|
|Bell County Health Department|
|Pineville, Kentucky, United States, 40977|
|Principal Investigator:||Daniel E Zoughbie, D.Phil.||Microclinic International|
|Principal Investigator:||Eric L Ding, Sc.D.||Harvard School of Public Health|