Diabetes Mellitus, Type 2NCT01818674
Microclinic Social Network Behavioral Health Trial in Jordan
A study testing Microclinic Behavioral Health Full Program (education curriculum in classroom setting, plus full social interaction program) and Microclinic Behavioral Health Basic Program (education-only in classroom setting; no structured social interactions) in people with Diabetes Mellitus, Type 2 and Obesity, run by Microclinic International at 3 sites in Jordan.
Trial summary
This 3-armed randomized controlled trial aims to evaluate the effectiveness of The Microclinic Behavioral Health Program in improving obesity and diabetes risk factors through a behavioral intervention program structured to enhance and promote social-network interactions and social support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity, Hypertension
- What is being tested?
- Microclinic Behavioral Health Full Program (education curriculum in classroom setting, plus full social interaction program) and Microclinic Behavioral Health Basic Program (education-only in classroom setting; no structured social interactions)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 914 participants
- Where
- 3 sitesJordan
- Study dates
- Jan 2012to Oct 2019
- 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
- diagnosed with type 2 diabetes, pre-diabetes, or 'at-risk for diabetes' (defined below)
- live in the catchment area of the study
- provide informed consent to participate.
Who cannot join
- participants who are not diagnosed with type 2 diabetes, pre-diabetes, or 'at-risk for diabetes'
- are not able to provide informed consent due to mental illness
- women who are pregnant.
- Pregnant women may participate in consultation with their physician. However, data related to their participation in the trial will not be included in data analysis.
- 'At-risk of diabetes' is defined as either: a) having a history of diabetes in close family AND being overweight/obese, or b) having a family history of diabetes AND having either high BP or high serum cholesterol.
Trial locations and contacts
3 sites in 1 country.
Jordan3 sites
Abu Nseir Ministry of Health Center
Amman
Kreibet Al Souq Ministry of Health Center
Amman
Naour Ministry of Health Center
Amman
About this study
Official title: Microclinic Social Network Behavioral Health Trial for Obesity and Metabolic Risk Factor Control in Jordan
This 3-armed randomized controlled trial aims to evaluate the effectiveness of The Microclinic Behavioral Health Program in improving obesity and diabetes risk factors through a behavioral intervention program structured to enhance and promote social-network interactions and social support. The full version of the Microclinic Behavioral Health Program (Full MCP) with program-activated social-network interactions-with shared access to diabetes education, technology, and group support to promote weight and metabolic control through diet, exercise, medication adherence, and blood pressure management. Participants play a role in the collective effort to combat diabetes and solidifying self-management behavioral skills through peer-monitoring and encouragement of lifestyle behaviors. The study may yield valuable information on the impact of social support and social network interactions for enhancing body weight and blood sugar control. We compare the full MCP intervention, to a basic MCP intervention with more limited classroom interaction, and to an parallel monitoring control arm. And we aim to understand how metabolic changes over time relate to the cross-propagation of health behaviors between persons in social networks.
This Microclinic Behavioral Health Program was established in collaboration with the Royal Health Awareness Society (RHAS) and the Jordanian Ministry of Health (MoH).
Read the detailed description
- Objectives
Because social network-based programs have shown promise as a viable public health intervention strategy, we designed the MCP program to leverage existing social relationships to propagate positive health behaviors in efforts to prevent and manage obesity and diabetes. We conduct a trial to examine the effectiveness of the Microclinic Behavioral Health Program via 3 arm trial in Jordan of a 6 month intervention with 2 years followup.
Furthermore, we aim to uncover the social mechanism of the intervention -- notably to define the pathways through which the social network behavioral health program worked by partitioning the different social network processes of direct causal induction (i.e. change catalyzed by a social network) from homophilly (i.e. where social networks are formed based on similar health behaviors), and confounding (i.e. correlation with exogenous shared variable). Notably, we seek to determine the presence of the amplification of metabolic changes over time due to the cross-propagation of health behaviors between persons in a social network.
II. Study Design
Randomized Control Study: This study is a randomized control study of adults (>= 18 years old) with Type 2 diabetes mellitus, pre-diabetes, or at risk for diabetes, who will be randomly assigned to an intervention group consisting of the Microclinic Behavioral Health Enhanced Program (Group A), a group who will receive the Microclinic Behavioral Health Basic Program without the social network components (Group B) , and controls receiving standard care and risk factor monitoring (Group C).
III. Study Procedures
- Participant Recruitment (1-3 months) The aim of recruitment is to inform individuals with diabetic, pre-diabetic, or at risk for diabetes in the community about the microclinic study, and encourage patients to participate. The recruitment process will consist of interconnected strategies including: 1) the distribution of posters and invitations in four catchment areas, and a broader media campaign, and 2) recruitment by nurses through clinics in two pilot locations around Amman.
Recruitment: Outreach strategies to recruit patients at risk for diabetes and with Type 2 diabetes include: a) The Royal Health Awareness Society will lead an outreach effort to spread the word about the Microclinic Social Network Behavioral Health Trial. The effort will involve distribution of posters and flyers in the public sphere, and, if possible, airing of radio or television spots. b) At the three assigned Ministry of Health local health centers, a Project Officer for each center will work with Project nurses trained in research, Institutional Review Board approved protocol, and data collection to recruit patients at risk for diabetes, pre-diabetes, and with type 2 diabetes to the Microclinic Social Network Behavioral Health Trial.
Potential participants, consisting of both local residents and refugees in Jordan will be contacted by phone or referred to the trial in person during their visit to local Jordan Ministry of Health centers and asked if they would be willing to participate.
Group A shall receive the 6 month Microclinic Behavioral Health Full Program, via trained Project Nurses, and a classroom curriculum that will increase the knowledge and skills in diabetes self-management and peer support and monitoring. The educational curriculum includes sessions on the causes of diabetes, prevention of complications, symptoms, self-management strategies, diet, exercise, but with emphasis on peer monitoring, social support, and structured social interactions. Each session is 2-3 hours.
Group B receiving a modified Microclinic Behavioral Health Basic Program that has the same educational curriculum and classroom setting, but a modified version that does not emphasize the importance of social support, without structured social interaction enhancing components. Group C receiving no intervention and therefore, standard care as the control group, with parallel measurement of risk factors (to alleviate monitoring bias).
A critical component of this project is the evaluation aimed at assessing the long term efficacy and sustainability of the Microclinic interventions in improving body weight and glucose in a resource limited setting over a 2 year time span. The program evaluation will collect demographic, medical history, clinical data, behavioral data from all participants during the 6 month main program as well as at 2 years after baseline.
- Conditions
- Diabetes Mellitus, Type 2, Obesity, Hypertension, Hyperglycemia, Blood Pressure, Hyperglycaemia (Diabetic)
- Being tested
- Microclinic Behavioral Health Full Program (education curriculum in classroom setting, plus full social interaction program), Microclinic Behavioral Health Basic Program (education-only in classroom setting; no structured social interactions)
- Keywords
- social network, microclinic, middle east, jordan, intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Hypertension, Hyperglycemia, Body Weight, Weight Loss, Body-Weight Trajectory, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microclinic Behavioral Health Full Program (education curriculum in classroom setting, plus full social interaction program)Behavioural
Also called Group A
A 6-month intervention program (sessions and educational materials) aims to increase knowledge and skills in diabetes self-management and peer support and monitoring. The curriculum include causes of diabetes, prevention of complications, symptoms, self-management strategies, diet, exercise, peer monitoring and support by trained Project nurses from MoH health centers, local physicians, and university professors. Each class will provide 2-3 hours of discussion to foster active class participation and engagement.
Microclinic Behavioral Health Basic Program (education-only in classroom setting; no structured social interactions)Behavioural
Also called Group B
This basic program (6 month) aims to increase participants knowledge about diabetes self-management, but without structured social interaction programming. While group classroom setting is still used for delivery of the educational curriculum, the education program in group B have no group-based or team-building activities, group goal setting, and classroom program is lecture style with more limited class participation and interaction.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Microclinic Behavioral Health Enhanced Program | Experimental | Group A received the Microclinic Behavioral Health Full Program (structured social interactions + fully interactive classroom education curriculum; parallel clinical screenings) Receives: Behavioral: Microclinic Behavioral Health Full Program (education curriculum in classroom setting, plus full social interaction program) |
| Group B - Microclinic Behavioral Health Basic Program | Experimental | Group B received the Microclinic Behavioral Health Basic Program (no social structured interactions; basic classroom education; parallel clinical screenings) Receives: Behavioral: Microclinic Behavioral Health Basic Program (education-only in classroom setting; no structured social interactions) |
| Group C - Controls with Parallel Monitoring | No intervention | Group C only received standard care, and only received parallel risk factor screening measurements; not participation in classroom or any social activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal change in body weight across all trial arms, over entire study
Change in body weight from baseline, a joint test of differences across all trial arms
Measured: Overall change across baseline, to 6 months, to 2 years
Longitudinal change in fasting blood glucose across all trial arms, over entire study
Change in fasting blood glucose from baseline, a joint test of differences across all trial arms
Measured: Overall change across baseline, to 6 months, to 2 years
Longitudinal change in glycosylated hemoglobin (HbA1c) across all trial arms, over entire study
Change in HbA1c from baseline, a joint test of differences across all trial arms
Measured: Overall change across baseline, to 6 months, to 2 years
Longitudinal change in blood pressure across all trial arms, over entire study
Change in mean arterial pressure (indexed from systolic and diastolic blood pressure) from baseline, a joint test of differences across all trial arms. mean arterial pressure was calculated using the clinical formula MAP=(SBP + (2*DBP))/3)
Measured: Overall change across baseline, to 6 months, to 2 years
Temporally investigate the causal induction of cascading changes in body weight between follow-ups on subsequent weight changes in other participants.
Using time intervals between follow-ups analyzed as separate induction timeframe windows, we estimate how weight loss observed in a previous time window predicts body weight change in subsequent followup intervals of the other participants.
Measured: Change from each session (weekly, biweekly, triweekly), on each subsequent session, during 6 month intervention period.
Secondary outcomes (4)
Relative changes in body weight between individual trial arms
Cross comparisons in longitudinal change in body weight between A vs. C, B vs. C, A vs. B.
Measured: Change from baseline, at 6 months, at 2 years
Relative changes in fasting glucose between individual trial arms
Cross comparisons in longitudinal change in fasting glucose between A vs. C, B vs. C, A vs. B.
Measured: Change from baseline, at 6 months, at 2 years
Relative changes in HbA1c between individual trial arms
Cross comparisons in longitudinal change in HbA1c between A vs. C, B vs. C, A vs. B.
Measured: Change from baseline, at 6 months, at 2 years
Relative changes in blood pressure between individual trial arms
Cross comparisons in longitudinal change in mean arterial pressure (indexed from systolic and diastolic blood pressure) between A vs. C, B vs. C, A vs. B. (mean arterial pressure was calculated using the clinical formula MAP=(SBP + (2*DBP))/3)
Measured: Change from baseline, at 6 months, at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startJan 2012
- Primary completionJun 2016
- Study completionOct 2019
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 2Studies 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
- 914 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microclinic International
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Health Awareness Society (RHAS), Ministry of Health Jordan
- 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
- NCT01818674
- Sponsor's protocol ID
- WDF2010-2014
- Status last verified
- Jan 2024
- First submitted
- 5 Mar 2013
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ding EL, Feigl AB, Watson KT, Ng TLJ, Makerechi L, Bui N, Ireifij A, Farraj R, Zoughbie DE. Social network enhanced behavioral interventions for diabetes and obesity: A 3 arm randomized trial with 2 years follow-up in Jordan. PLOS Glob Public Health. 2024 Mar 20;4(3):e0001514. doi: 10.1371/journal.pgph.0001514. eCollection 2024.
PubMed 38507441
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microclinic Social Network Behavioral Health Trial for Obesity and Metabolic Risk Factor Control in Jordan
- ClinicalTrials.gov ID
- NCT01818674
- Acronym / sponsor ID
- WDF2010-2014
- Conditions
- Diabetes Mellitus, Type 2, Obesity, Hypertension, Hyperglycemia, Blood Pressure, Hyperglycaemia (Diabetic)
- Keywords
- social network, microclinic, middle east, jordan, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 914 participants (actual)
- Lead sponsor
- Microclinic InternationalUniversity, hospital or other
- Collaborators
- Royal Health Awareness Society (RHAS), Ministry of Health Jordan
- Study start
- Jan 2012 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 26 Mar 2013 (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.
This 3-armed randomized controlled trial aims to evaluate the effectiveness of The Microclinic Behavioral Health Program in improving obesity and diabetes risk factors through a behavioral intervention program structured to enhance and promote social-network interactions and social support. The full version of the Microclinic Behavioral Health Program (Full MCP) with program-activated social-network interactions-with shared access to diabetes education, technology, and group support to promote weight and metabolic control through diet, exercise, medication adherence, and blood pressure management. Participants play a role in the collective effort to combat diabetes and solidifying self-management behavioral skills through peer-monitoring and encouragement of lifestyle behaviors. The study may yield valuable information on the impact of social support and social network interactions for enhancing body weight and blood sugar control. We compare the full MCP intervention, to a basic MCP intervention with more limited classroom interaction, and to an parallel monitoring control arm. And we aim to understand how metabolic changes over time relate to the cross-propagation of health behaviors between persons in social networks.
This Microclinic Behavioral Health Program was established in collaboration with the Royal Health Awareness Society (RHAS) and the Jordanian Ministry of Health (MoH).
Detailed description
- Objectives
Because social network-based programs have shown promise as a viable public health intervention strategy, we designed the MCP program to leverage existing social relationships to propagate positive health behaviors in efforts to prevent and manage obesity and diabetes. We conduct a trial to examine the effectiveness of the Microclinic Behavioral Health Program via 3 arm trial in Jordan of a 6 month intervention with 2 years followup.
Furthermore, we aim to uncover the social mechanism of the intervention -- notably to define the pathways through which the social network behavioral health program worked by partitioning the different social network processes of direct causal induction (i.e. change catalyzed by a social network) from homophilly (i.e. where social networks are formed based on similar health behaviors), and confounding (i.e. correlation with exogenous shared variable). Notably, we seek to determine the presence of the amplification of metabolic changes over time due to the cross-propagation of health behaviors between persons in a social network.
II. Study Design
Randomized Control Study: This study is a randomized control study of adults (>= 18 years old) with Type 2 diabetes mellitus, pre-diabetes, or at risk for diabetes, who will be randomly assigned to an intervention group consisting of the Microclinic Behavioral Health Enhanced Program (Group A), a group who will receive the Microclinic Behavioral Health Basic Program without the social network components (Group B) , and controls receiving standard care and risk factor monitoring (Group C).
III. Study Procedures
- Participant Recruitment (1-3 months) The aim of recruitment is to inform individuals with diabetic, pre-diabetic, or at risk for diabetes in the community about the microclinic study, and encourage patients to participate. The recruitment process will consist of interconnected strategies including: 1) the distribution of posters and invitations in four catchment areas, and a broader media campaign, and 2) recruitment by nurses through clinics in two pilot locations around Amman.
Recruitment: Outreach strategies to recruit patients at risk for diabetes and with Type 2 diabetes include: a) The Royal Health Awareness Society will lead an outreach effort to spread the word about the Microclinic Social Network Behavioral Health Trial. The effort will involve distribution of posters and flyers in the public sphere, and, if possible, airing of radio or television spots. b) At the three assigned Ministry of Health local health centers, a Project Officer for each center will work with Project nurses trained in research, Institutional Review Board approved protocol, and data collection to recruit patients at risk for diabetes, pre-diabetes, and with type 2 diabetes to the Microclinic Social Network Behavioral Health Trial.
Potential participants, consisting of both local residents and refugees in Jordan will be contacted by phone or referred to the trial in person during their visit to local Jordan Ministry of Health centers and asked if they would be willing to participate.
Group A shall receive the 6 month Microclinic Behavioral Health Full Program, via trained Project Nurses, and a classroom curriculum that will increase the knowledge and skills in diabetes self-management and peer support and monitoring. The educational curriculum includes sessions on the causes of diabetes, prevention of complications, symptoms, self-management strategies, diet, exercise, but with emphasis on peer monitoring, social support, and structured social interactions. Each session is 2-3 hours.
Group B receiving a modified Microclinic Behavioral Health Basic Program that has the same educational curriculum and classroom setting, but a modified version that does not emphasize the importance of social support, without structured social interaction enhancing components. Group C receiving no intervention and therefore, standard care as the control group, with parallel measurement of risk factors (to alleviate monitoring bias).
A critical component of this project is the evaluation aimed at assessing the long term efficacy and sustainability of the Microclinic interventions in improving body weight and glucose in a resource limited setting over a 2 year time span. The program evaluation will collect demographic, medical history, clinical data, behavioral data from all participants during the 6 month main program as well as at 2 years after baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A - Microclinic Behavioral Health Enhanced Program | Experimental | Behavioral: Microclinic Behavioral Health Full Program (education curriculum in classroom setting, plus full social interaction program)Group A received the Microclinic Behavioral Health Full Program (structured social interactions + fully interactive classroom education curriculum; parallel clinical screenings) |
| Group B - Microclinic Behavioral Health Basic Program | Experimental | Behavioral: Microclinic Behavioral Health Basic Program (education-only in classroom setting; no structured social interactions)Group B received the Microclinic Behavioral Health Basic Program (no social structured interactions; basic classroom education; parallel clinical screenings) |
| Group C - Controls with Parallel Monitoring | No intervention | –Group C only received standard care, and only received parallel risk factor screening measurements; not participation in classroom or any social activities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed with type 2 diabetes, pre-diabetes, or 'at-risk for diabetes' (defined below)
- live in the catchment area of the study
- provide informed consent to participate.
Key exclusion criteria (5 listed)
- participants who are not diagnosed with type 2 diabetes, pre-diabetes, or 'at-risk for diabetes'
- are not able to provide informed consent due to mental illness
- women who are pregnant.
- 'At-risk of diabetes' is defined as either: a) having a history of diabetes in close family AND being overweight/obese, or b) having a family history of diabetes AND having either high BP or high serum cholesterol.
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 Behavioral Health Full Program (education curriculum in classroom setting, plus full social interaction program)Also: Group AA 6-month intervention program (sessions and educational materials) aims to increase knowledge and skills in diabetes self-management and peer support and monitoring. The curriculum include causes of diabetes, prevention of complications, symptoms, self-management strategies, diet, exercise, peer monitoring and support by trained Project nurses from MoH health centers, local physicians, and university professors. Each class will provide 2-3 hours of discussion to foster active class participation and engagement. | Behavioural | Group A - Microclinic Behavioral Health Enhanced Program |
| Microclinic Behavioral Health Basic Program (education-only in classroom setting; no structured social interactions)Also: Group BThis basic program (6 month) aims to increase participants knowledge about diabetes self-management, but without structured social interaction programming. While group classroom setting is still used for delivery of the educational curriculum, the education program in group B have no group-based or team-building activities, group goal setting, and classroom program is lecture style with more limited class participation and interaction. | Behavioural | Group B - Microclinic Behavioral Health Basic Program |
Primary outcome
Longitudinal change in body weight across all trial arms, over entire study
Time frame: Overall change across baseline, to 6 months, to 2 years
Change in body weight from baseline, a joint test of differences across all trial arms
Longitudinal change in fasting blood glucose across all trial arms, over entire study
Time frame: Overall change across baseline, to 6 months, to 2 years
Change in fasting blood glucose from baseline, a joint test of differences across all trial arms
Longitudinal change in glycosylated hemoglobin (HbA1c) across all trial arms, over entire study
Time frame: Overall change across baseline, to 6 months, to 2 years
Change in HbA1c from baseline, a joint test of differences across all trial arms
Longitudinal change in blood pressure across all trial arms, over entire study
Time frame: Overall change across baseline, to 6 months, to 2 years
Change in mean arterial pressure (indexed from systolic and diastolic blood pressure) from baseline, a joint test of differences across all trial arms. mean arterial pressure was calculated using the clinical formula MAP=(SBP + (2*DBP))/3)
Temporally investigate the causal induction of cascading changes in body weight between follow-ups on subsequent weight changes in other participants.
Time frame: Change from each session (weekly, biweekly, triweekly), on each subsequent session, during 6 month intervention period.
Using time intervals between follow-ups analyzed as separate induction timeframe windows, we estimate how weight loss observed in a previous time window predicts body weight change in subsequent followup intervals of the other participants.
4 secondary outcomes
Relative changes in body weight between individual trial arms
Time frame: Change from baseline, at 6 months, at 2 years
Relative changes in fasting glucose between individual trial arms
Time frame: Change from baseline, at 6 months, at 2 years
Relative changes in HbA1c between individual trial arms
Time frame: Change from baseline, at 6 months, at 2 years
Relative changes in blood pressure between individual trial arms
Time frame: Change from baseline, at 6 months, at 2 years
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 1 Feb 2024.
- Derived from this study: PubMed 38507441Ding EL, Feigl AB, Watson KT, Ng TLJ, Makerechi L, Bui N, Ireifij A, Farraj R, Zoughbie DE. Social network enhanced behavioral interventions for diabetes and obesity: A 3 arm randomized trial with 2 years follow-up in Jordan. PLOS Glob Public Health. 2024 Mar 20;4(3):e0001514. doi: 10.1371/journal.pgph.0001514. eCollection 2024.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microclinic Behavioral Health Full Program (education curriculum in classroom setting, plus full social interaction program) and Microclinic Behavioral Health Basic Program (education-only in classroom setting; no structured social interactions) in people with Diabetes Mellitus, Type 2 and Obesity, run by Microclinic International at 3 sites in Jordan.
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 3 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 1 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 3 sites in Jordan. 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?
Longitudinal change in body weight across all trial arms, over entire study (time frame: Overall change across baseline, to 6 months, to 2 years). The study lists 5 primary outcomes in all. 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 NCT01818674, 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 1 Feb 2024.