Micro-Clinic Obesity and Metabolic Risk Prevention Program

NCT ID: NCT01651065

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 494 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2014-12-31

Brief 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

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.

Conditions

Diabetes Mellitus, Type II; Heart Disease; Obesity; Hypertension; Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Microclinic Diabetes Education Program

Intervention Type: BEHAVIORAL

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 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.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: BEHAVIORAL

Interventions

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.

Intervention Type: BEHAVIORAL

Control

Intervention Type: BEHAVIORAL

Eligibility Criteria

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*

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bell County Department of Health, Kentucky

UNKNOWN

Sponsor Role: collaborator

Microclinic International

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel E Zoughbie, D.Phil.

Role: PRINCIPAL_INVESTIGATOR

Microclinic International

Eric L Ding, Sc.D.

Role: PRINCIPAL_INVESTIGATOR

New England Complex Systems Institute

Locations

Bell County Health Department

Pineville, Kentucky, United States

Countries

United States

References

Ding EL, Watson KT, Makarechi L, James Ng TL, Huddleston D, Bui N, Tsai LL, Zoughbie DE. Social Induction via a Social Behavioral Intervention on Changes in Metabolic Risk Factors: A Randomized Controlled Trial in Rural Appalachia, United States. Mayo Clin Proc. 2024 Jul;99(7):1058-1077. doi: 10.1016/j.mayocp.2023.11.023.

Reference Type: DERIVED

PMID: 38960495 (View on PubMed)

Other Identifiers

20110766

Identifier Type: -

Identifier Source: org_study_id