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Micro-Clinic Obesity and Metabolic Risk Prevention Program

Primary Purpose

Diabetes Mellitus, Type II, Heart Disease, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Microclinic Diabetes Education Program
Control
Sponsored by
Microclinic International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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*

Sites / Locations

  • Bell County Health Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Microclinic Social Network Program

Active Controls

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Weight
Change in weight overtime

Secondary Outcome Measures

Waist circumference
Change in waist measurement overtime
Blood pressure
Change in systolic/diastolic blood pressure overtime
HDL
Change in HDL overtime
Hemoglobin A1c (%, HbA1c)
Change in HbA1c overtime

Full Information

First Posted
July 24, 2012
Last Updated
November 3, 2022
Sponsor
Microclinic International
Collaborators
Bell County Department of Health, Kentucky
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1. Study Identification

Unique Protocol Identification Number
NCT01651065
Brief Title
Micro-Clinic Obesity and Metabolic Risk Prevention Program
Official Title
Micro-Clinic Obesity and Metabolic Risk Prevention Program: A Randomized-Control Trial of a Social-Network Based Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Microclinic International
Collaborators
Bell County Department of Health, Kentucky

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type II, Heart Disease, Obesity, Hypertension, Dyslipidemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
494 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Microclinic Social Network Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Controls
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Microclinic Diabetes Education Program
Intervention Description
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
Intervention Name(s)
Control
Primary Outcome Measure Information:
Title
Weight
Description
Change in weight overtime
Time Frame
Seven collected time points from baseline until final session at 10/9 months, and 6 months post-intervention
Secondary Outcome Measure Information:
Title
Waist circumference
Description
Change in waist measurement overtime
Time Frame
Seven collected time points from baseline until final session at 10/9 months, and 6 months post-intervention
Title
Blood pressure
Description
Change in systolic/diastolic blood pressure overtime
Time Frame
Seven collected time points from baseline until final session at 10/9 months, and 6 months post-intervention
Title
HDL
Description
Change in HDL overtime
Time Frame
Seven collected time points from baseline until final session at 10/9 months, and 6 months post-intervention
Title
Hemoglobin A1c (%, HbA1c)
Description
Change in HbA1c overtime
Time Frame
Seven collected time points from baseline until final session at 10/9 months, and 6 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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*
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel E Zoughbie, D.Phil.
Organizational Affiliation
Microclinic International
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric L Ding, Sc.D.
Organizational Affiliation
New England Complex Systems Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bell County Health Department
City
Pineville
State/Province
Kentucky
ZIP/Postal Code
40977
Country
United States

12. IPD Sharing Statement

Links:
URL
http://microclinics.org
Description
Related Info

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Micro-Clinic Obesity and Metabolic Risk Prevention Program

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