Micro-Clinic Obesity and Metabolic Risk Prevention Program

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651065
• Other study ID #: 20110766
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: December 2014

Study information

• Verified date: February 2024
• Source: Microclinic International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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*

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II
• Dyslipidemia
• Dyslipidemias
• Heart Disease
• Heart Diseases
• Hypertension
• Obesity

Intervention

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.
• Control

Locations

Country	Name	City	State
United States	Bell County Health Department	Pineville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Microclinic International	Bell County Department of Health, Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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.
Primary	Weight	Change in weight over time	From baseline until end of intervention period (9-10 months), and 6 months post-intervention
Secondary	Waist circumference	Change in waist measurement over time	From baseline until end of intervention period (9-10 months), and 6 months post-intervention
Secondary	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
Secondary	HDL	Change in HDL over time	From baseline until end of intervention period (9-10 months), and 6 months post-intervention
Secondary	Hemoglobin A1c (%, HbA1c)	Change in HbA1c over time	From baseline until end of intervention period (9-10 months), and 6 months post-intervention

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