Micro-Clinic Obesity and Metabolic Risk Prevention Program
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), High Cholesterol, Obesity Weight Loss, Peripheral Vascular Disease, Cardiology, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2011 |
| End Date: | December 2014 |
Micro-Clinic Obesity and Metabolic Risk Prevention Program: A Randomized-Control Trial of a Social-Network Based Intervention
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
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
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.
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.
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*
We found this trial at
1
site
Click here to add this to my saved trials
