Diabetes Mellitus, Type IINCT01651065
Micro-Clinic Obesity and Metabolic Risk Prevention Program
A study testing Microclinic Diabetes Education Program in people with Diabetes Mellitus, Type II and Heart Disease, run by Microclinic International at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type II, Heart Disease, Obesity
- What is being tested?
- Microclinic Diabetes Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 494 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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*
Trial locations and contacts
1 site in 1 country.
United States1 site
Bell County Health Department
Pineville, Kentucky, 40977
About this study
Official title: 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
Read the 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.
- Conditions
- Diabetes Mellitus, Type II, Heart Disease, Obesity, Hypertension, Dyslipidemia
- Being tested
- Microclinic Diabetes Education Program, Control
- Medical subject headings
- Diabetes Mellitus, Type 2, Heart Diseases, Obesity, Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microclinic Diabetes Education ProgramBehavioural
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.
ControlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Microclinic Social Network Program | Experimental | 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. Receives: Behavioral: Microclinic Diabetes Education Program |
| Active Controls | Active comparator | 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Change in weight over time
Measured: From baseline until end of intervention period (9-10 months), and 6 months post-intervention
Secondary outcomes (4)
Waist circumference
Change in waist measurement over time
Measured: From baseline until end of intervention period (9-10 months), and 6 months post-intervention
Blood pressure
Change in systolic/diastolic blood pressure over time
Measured: From baseline until end of intervention period (9-10 months), and 6 months post-intervention
HDL
Change in HDL over time
Measured: From baseline until end of intervention period (9-10 months), and 6 months post-intervention
Hemoglobin A1c (%, HbA1c)
Change in HbA1c over time
Measured: From baseline until end of intervention period (9-10 months), and 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startJun 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microclinic International
- Sponsor type
- University, hospital or other
- Collaborators
- Bell County Department of Health, Kentucky
- Responsible party
- Sponsor
- Investigators
- Daniel E Zoughbie, D.Phil., Principal investigator, Microclinic InternationalEric L Ding, Sc.D., Principal investigator, New England Complex Systems Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651065
- Sponsor's protocol ID
- 20110766
- Status last verified
- Feb 2024
- First submitted
- 24 Jul 2012
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38960495
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro-Clinic Obesity and Metabolic Risk Prevention Program: A Randomized-Control Trial of a Social-Network Based Intervention
- ClinicalTrials.gov ID
- NCT01651065
- Acronym / sponsor ID
- 20110766
- Conditions
- Diabetes Mellitus, Type II, Heart Disease, Obesity, Hypertension, Dyslipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- Microclinic InternationalUniversity, hospital or other
- Collaborators
- Bell County Department of Health, Kentucky
- Study start
- Jun 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microclinic Social Network Program | Experimental | Behavioral: Microclinic Diabetes Education ProgramSubjects 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 comparator | Behavioral: ControlIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microclinic Diabetes Education ProgramThe 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. | Behavioural | Microclinic Social Network Program |
| Control | Behavioural | Active Controls |
Primary outcome
Weight
Time frame: From baseline until end of intervention period (9-10 months), and 6 months post-intervention
Change in weight over time
4 secondary outcomes
Waist circumference
Time frame: From baseline until end of intervention period (9-10 months), and 6 months post-intervention
Blood pressure
Time frame: From baseline until end of intervention period (9-10 months), and 6 months post-intervention
HDL
Time frame: From baseline until end of intervention period (9-10 months), and 6 months post-intervention
Hemoglobin A1c (%, HbA1c)
Time frame: From baseline until end of intervention period (9-10 months), and 6 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Derived from this study: PubMed 38960495Ding 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel E Zoughbie, D.Phil. principal investigator
Microclinic International
Eric L Ding, Sc.D. principal investigator
New England Complex Systems Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microclinic Diabetes Education Program in people with Diabetes Mellitus, Type II and Heart Disease, run by Microclinic International at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: From baseline until end of intervention period (9-10 months), and 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01651065, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.