Micro-Clinic Obesity and Metabolic Risk Prevention Program

Micro-Clinic Obesity and Metabolic Risk Prevention Program: A Randomized-Control Trial of a Social-Network Based Intervention

The purpose of this randomized trial is to study the efficacy of a novel social propagation intervention which integrates social network induction with health education for weight and metabolic control among patients with type 2 diabetes, BMI of 25-30+, and cardiovascular disease. The intervention takes place in the form of a community health program, where participants who enroll in this program will be asked if they would like to take part in the study to evaluate its efficacy. Thus, the investigators will study the efficacy of social networks in propagating changes in lifestyle factors for diabetes and chronic disease management

Study Overview

• Status: Completed
• Conditions: Hypertension; Obesity; Dyslipidemia; Heart Disease; Diabetes Mellitus, Type II
• Intervention / Treatment: Behavioral: Control; Behavioral: Microclinic Diabetes Education Program

Detailed Description

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
• Enrollment (Actual): 494
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Pineville, Kentucky, United States, 40977
      • Bell County Health Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Must be enrolled in our community health program.
• Over the age of 18
• BMI of 30 or higher, or
• BMI of 25 or higher AND must be diagnosed with at least one additional risk factor 1) type 2 diabetes, 2) high blood pressure, and/or 3) high cholesterol
• For those who will be participating in the cross-over sub-sample, they must have previously participated in Phase 1 as subject of the control group, or

Exclusion Criteria:

• Patients who are not enrolled in the our community health education program (applies to Phase 1 only)
• Are not able to provide informed consent for themselves
• Under the age of 18
• Has undergone weight loss surgery
• Pregnant women*

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microclinic Social Network Program; 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.
Active Comparator: Active Controls; Individuals will receive screening by clinical staff. Control group subjects are offered standard of care from local health department, but will not participate in program activities, other than offered option to join open-community health events.	Behavioral: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Change in weight over time	From baseline until end of intervention period (9-10 months), and 6 months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist circumference	Change in waist measurement over time	From baseline until end of intervention period (9-10 months), and 6 months post-intervention
Blood pressure	Change in systolic/diastolic blood pressure over time	From baseline until end of intervention period (9-10 months), and 6 months post-intervention
HDL	Change in HDL over time	From baseline until end of intervention period (9-10 months), and 6 months post-intervention
Hemoglobin A1c (%, HbA1c)	Change in HbA1c over time	From baseline until end of intervention period (9-10 months), and 6 months post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social network induction and clustering	Investigate the magnitude of social network-driven clustering (via hierarchal multilevel analysis) on the longitudinal trajectories of body mass, lipids, and HbA1c changes. Specifically, assess the relative magnitude of intraclass correlation of microclinics, classroom, cohort, and geographic neighborhoods.	From baseline to end of intervention period (9-10 months)
Temporally investigate the causal induction of cascading changes in body weight between follow-ups on subsequent weight changes in other participants.	Using time intervals between follow-ups analyzed as separate induction timeframe windows, we estimate how weight loss observed in a previous time window predicts body weight change in subsequent followup intervals of the other participants.	Change from each regularly scheduled classroom session, on each subsequent session, during intervention period.

Collaborators and Investigators

• Sponsor: Microclinic International
• Collaborators: Bell County Department of Health, Kentucky
• Investigators: Principal Investigator: Daniel E Zoughbie, D.Phil., Microclinic International; Principal Investigator: Eric L Ding, Sc.D., New England Complex Systems Institute

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: July 24, 2012
• First Submitted That Met QC Criteria: July 24, 2012
• First Posted (Estimated): July 26, 2012

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Lipid Metabolism Disorders; Heart Diseases; Diabetes Mellitus, Type 2; Obesity; Dyslipidemias
• Other Study ID Numbers: 20110766