Micro-Clinic Obesity and Metabolic Risk Prevention Program

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bell County Department of Health, Kentucky
Information provided by (Responsible Party):
Microclinic International
ClinicalTrials.gov Identifier:
NCT01651065
First received: July 24, 2012
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention
Diabetes Mellitus, Type II
Heart Disease
Obesity
Hypertension
Dyslipidemia
Behavioral: Microclinic Diabetes Education Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Micro-Clinic Obesity and Metabolic Risk Prevention Program: A Randomized-Control Trial of a Social-Network Based Intervention

Resource links provided by NLM:


Further study details as provided by Microclinic International:

Primary Outcome Measures:
  • Weight [ Time Frame: Seven collected time points from baseline until final session at 10/9 months ] [ Designated as safety issue: No ]
    Change in weight overtime


Secondary Outcome Measures:
  • Waist circumference [ Time Frame: Seven collected time points from baseline until final session at 10/9 months ] [ Designated as safety issue: No ]
    Change in waist measurement overtime

  • Blood pressure [ Time Frame: Seven collected time points from baseline until final session at 10/9 months ] [ Designated as safety issue: No ]
    Change in systolic/diastolic blood pressure overtime

  • HDL [ Time Frame: Seven collected time points from baseline until final session at 10/9 months ] [ Designated as safety issue: No ]
    Change in HDL overtime

  • Hemoglobin A1c (%, HbA1c) [ Time Frame: Seven collected time points from baseline until final session at 10/9 months ] [ Designated as safety issue: No ]
    Change in HbA1c overtime


Estimated Enrollment: 1100
Study Start Date: June 2011
Estimated Study Completion Date: December 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Microclinics Group A
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.

Placebo Comparator: Group C Controls
Individuals will receive screening by clinical staff. Control group subjects will receive clinic screenings only; they will not participate in program activities.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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*
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651065

Locations
United States, Kentucky
Bell County Health Department
Pineville, Kentucky, United States, 40977
Sponsors and Collaborators
Microclinic International
Bell County Department of Health, Kentucky
Investigators
Principal Investigator: Daniel E Zoughbie, D.Phil. Microclinic International
Principal Investigator: Eric L Ding, Sc.D. Harvard School of Public Health
  More Information

Additional Information:
No publications provided

Responsible Party: Microclinic International
ClinicalTrials.gov Identifier: NCT01651065     History of Changes
Other Study ID Numbers: 20110766
Study First Received: July 24, 2012
Last Updated: September 9, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Dyslipidemias
Heart Diseases
Hypertension
Obesity
Body Weight
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Lipid Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014