Micro-Clinic Obesity and Metabolic Risk Prevention Program
1 other identifier
interventional
494
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 24, 2012
CompletedFirst Posted
Study publicly available on registry
July 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 7, 2024
February 1, 2024
3.5 years
July 24, 2012
February 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Weight
Change in weight over time
From baseline until end of intervention period (9-10 months), and 6 months post-intervention
Secondary Outcomes (4)
Waist circumference
From baseline until end of intervention period (9-10 months), and 6 months post-intervention
Blood pressure
From baseline until end of intervention period (9-10 months), and 6 months post-intervention
HDL
From baseline until end of intervention period (9-10 months), and 6 months post-intervention
Hemoglobin A1c (%, HbA1c)
From baseline until end of intervention period (9-10 months), and 6 months post-intervention
Other Outcomes (2)
Social network induction and clustering
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.
Change from each regularly scheduled classroom session, on each subsequent session, during intervention period.
Study Arms (2)
Microclinic Social Network Program
EXPERIMENTALSubjects 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.
Active Controls
ACTIVE COMPARATORIndividuals 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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\*
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bell County Health Department
Pineville, Kentucky, 40977, United States
Related Publications (1)
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.
PMID: 38960495DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel E Zoughbie, D.Phil.
Microclinic International
- PRINCIPAL INVESTIGATOR
Eric L Ding, Sc.D.
New England Complex Systems Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2012
First Posted
July 26, 2012
Study Start
June 1, 2011
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
February 7, 2024
Record last verified: 2024-02