Clinical trial NCT01651065: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type II
Heart Disease
Obesity
Hypertension
Dyslipidemia
Lead sponsor: Microclinic International
Sponsor class: OTHER
Collaborators: name: Bell County Department of Health, Kentucky
First posted: 2012-07-26
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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\*

Primary outcomes:
measure: Weight
timeFrame: From baseline until end of intervention period (9-10 months), and 6 months post-intervention
Secondary outcomes:
measure: Waist circumference
timeFrame: From baseline until end of intervention period (9-10 months), and 6 months post-intervention
measure: Blood pressure
timeFrame: From baseline until end of intervention period (9-10 months), and 6 months post-intervention
measure: HDL
timeFrame: From baseline until end of intervention period (9-10 months), and 6 months post-intervention
measure: Hemoglobin A1c (%, HbA1c)
timeFrame: From baseline until end of intervention period (9-10 months), and 6 months post-intervention
Other outcomes:
measure: Social network induction and clustering
timeFrame: From baseline to end of intervention period (9-10 months)
measure: Temporally investigate the causal induction of cascading changes in body weight between follow-ups on subsequent weight changes in other participants.
timeFrame: Change from each regularly scheduled classroom session, on each subsequent session, during intervention period.
Locations:
city: Pineville
country: United States
facility: Bell County Health Department
state: Kentucky
Study officials:
affiliation: Microclinic International
name: Daniel E Zoughbie, D.Phil.
role: PRINCIPAL_INVESTIGATOR
affiliation: New England Complex Systems Institute
name: Eric L Ding, Sc.D.
role: PRINCIPAL_INVESTIGATOR
References: