Diabetes Mellitus, Type IINCT01596244
Jordan Diabetes Microclinic Project
A study testing Microclinic in people with Diabetes Mellitus, Type II, run by Microclinic International at 2 sites in Jordan.
Trial summary
The purpose of the study is to provide participants in economically depressed areas of Jordan essential knowledge, practical skills, and intimate support groups-called microclinics-for managing their diabetes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type II
- What is being tested?
- Microclinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 2 sitesJordan
- Study dates
- Apr 2008to Aug 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years old
- Mentally competent
- Have diabetes or pre-diabetes or brought a family member who was diabetic/pre-diabetic (Diabetes: Fasting blood glucose higher than 125 mg/dl; Pre-diabetes: Fasting blood glucose between 100 and 124 mg/dl.)
Who cannot join
- They do not meet the above criteria
- They are pregnant
- They have significant medical complications that prevent them from making changes to diet or level of physical activity.
Trial locations and contacts
2 sites in 1 country.
Jordan2 sites
Ein El-Basha Ministry of Health Center
Amman
Jabl Nasr Ministry of Health Center
Amman
About this study
Official title: Pilot and Expansion Project for the Jordan Diabetes Microclinic Project
The purpose of the study is to provide participants in economically depressed areas of Jordan essential knowledge, practical skills, and intimate support groups-called microclinics-for managing their diabetes. Microclinics consist of 2-8 individuals from pre-existing social networks (friends, relatives, coworkers, neighbors, etc) that voluntarily participate in ongoing education and medical monitoring from local health care professionals, learning and practicing diabetes management strategies, sharing much-needed medical supplies, and exchanging social support in the form of regular micro-clinic meetings.
Read the detailed description
The Global Microclinic Project seeks to empower people to prevent and manage diseases in economically depressed areas Jordan. The project seeks to more broadly link health education opportunities in the form of lectures and seminars with practical experience through workshops and hands-on learning, ultimately resulting in the creation of microclinics. Microclinics are intimate support groups of diabetic patients (2-8 per clinic) who meet in their homes and businesses in order to share the costs of maintaining medical monitoring equipment and supplies, come together to support one another in the management of diabetes, collectively utilize vital treatment options, and receive personalized screening, education and management tools from medical professionals.
The microclinics concept is ideal for the management of chronic disorders such as diabetes, a disease which requires ongoing education about diet and exercise and regular monitoring of health indices such as blood glucose levels and weight change. Indeed, the microclinics model has been established successfully in the West Bank specifically to combat diabetes. The goal here is to extend the model to Jordan and to establish microclinics in a collaborative effort with the Royal Health Awareness Society (RHAS) and the Jordanian Ministry of Health (MoH).
- Conditions
- Diabetes Mellitus, Type II
- Being tested
- Microclinic
- Keywords
- Diabetes Mellitus, Type II, Disease management, Chronic disease, Prevention and control, Education
- Medical subject headings
- Diabetes Mellitus, Type 2, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroclinicBehavioural
Microclinics consist of 2-8 individuals from pre-existing social networks (friends, relatives, coworkers, neighbors, etc) that voluntarily participate in ongoing education and medical monitoring from local health care professionals, learning and practicing diabetes management strategies, sharing much-needed medical supplies, and exchanging social support in the form of regular microclinic meetings.
| Study group | Role | What they receive |
|---|---|---|
| Microclinics training | Experimental | Diabetic, pre-diabetic, or those with family members who are diabetic/pre-diabetic who participated in a 4 month long intervention with a focus on disease management, health behavior change, and social network supports in order to improve chronic disease risk factors. Receives: Behavioral: Microclinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight (kg)
Change in weight overtime
Measured: Baseline, 4 months (intervention), and 12 months (post-intervention)
Secondary outcomes (3)
Fasting Blood Glucose (mg/dl)
Change in fasting blood glucose overtime
Measured: Baseline, 4 months, 12 months
Hemoglobin A1c (%, HBA1c)
Change in HBA1c overtime
Measured: Baseline, 4 months, 12 months
Body Mass Index (kg/m2)
Change in body mass index overtime
Measured: Baseline, 4 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startApr 2008
- Primary completionApr 2011
- Study completionAug 2012
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microclinic International
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health Jordan, Royal Health Awareness Society (RHAS), Jordan
- Responsible party
- Sponsor
- Investigators
- Daniel Zoughbie, DPhil, Principal investigator, Microclinic InternationalEric Ding, PhD, Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596244
- Sponsor's protocol ID
- WDF07-231
- Other IDs
- LT07-135
- Status last verified
- Nov 2012
- First submitted
- 9 May 2012
- Last updated
- 8 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Zoughbie DE, Ng TLJ, Thompson JY, Watson KT, Farraj R, Ding EL. Ramadan fasting and weight change trajectories: Time-varying association of weight during and after Ramadan in low-income and refugee populations. PLOS Glob Public Health. 2022 Oct 26;2(10):e0000371. doi: 10.1371/journal.pgph.0000371. eCollection 2022.
PubMed 36962504
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot and Expansion Project for the Jordan Diabetes Microclinic Project
- ClinicalTrials.gov ID
- NCT01596244
- Acronym / sponsor ID
- WDF07-231
- Conditions
- Diabetes Mellitus, Type II
- Keywords
- Diabetes Mellitus, Type II, Disease management, Chronic disease, Prevention and control, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- Microclinic InternationalUniversity, hospital or other
- Collaborators
- Ministry of Health Jordan, Royal Health Awareness Society (RHAS), Jordan
- Study start
- Apr 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 10 May 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 the study is to provide participants in economically depressed areas of Jordan essential knowledge, practical skills, and intimate support groups-called microclinics-for managing their diabetes. Microclinics consist of 2-8 individuals from pre-existing social networks (friends, relatives, coworkers, neighbors, etc) that voluntarily participate in ongoing education and medical monitoring from local health care professionals, learning and practicing diabetes management strategies, sharing much-needed medical supplies, and exchanging social support in the form of regular micro-clinic meetings.
Detailed description
The Global Microclinic Project seeks to empower people to prevent and manage diseases in economically depressed areas Jordan. The project seeks to more broadly link health education opportunities in the form of lectures and seminars with practical experience through workshops and hands-on learning, ultimately resulting in the creation of microclinics. Microclinics are intimate support groups of diabetic patients (2-8 per clinic) who meet in their homes and businesses in order to share the costs of maintaining medical monitoring equipment and supplies, come together to support one another in the management of diabetes, collectively utilize vital treatment options, and receive personalized screening, education and management tools from medical professionals.
The microclinics concept is ideal for the management of chronic disorders such as diabetes, a disease which requires ongoing education about diet and exercise and regular monitoring of health indices such as blood glucose levels and weight change. Indeed, the microclinics model has been established successfully in the West Bank specifically to combat diabetes. The goal here is to extend the model to Jordan and to establish microclinics in a collaborative effort with the Royal Health Awareness Society (RHAS) and the Jordanian Ministry of Health (MoH).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microclinics training | Experimental | Behavioral: MicroclinicDiabetic, pre-diabetic, or those with family members who are diabetic/pre-diabetic who participated in a 4 month long intervention with a focus on disease management, health behavior change, and social network supports in order to improve chronic disease risk factors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years old
- Mentally competent
- Have diabetes or pre-diabetes or brought a family member who was diabetic/pre-diabetic (Diabetes: Fasting blood glucose higher than 125 mg/dl; Pre-diabetes: Fasting blood glucose between 100 and 124 mg/dl.)
Key exclusion criteria (3 listed)
- They do not meet the above criteria
- They are pregnant
- They have significant medical complications that prevent them from making changes to diet or level of physical activity.
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 |
|---|---|---|
| MicroclinicMicroclinics consist of 2-8 individuals from pre-existing social networks (friends, relatives, coworkers, neighbors, etc) that voluntarily participate in ongoing education and medical monitoring from local health care professionals, learning and practicing diabetes management strategies, sharing much-needed medical supplies, and exchanging social support in the form of regular microclinic meetings. | Behavioural | Microclinics training |
Primary outcome
Weight (kg)
Time frame: Baseline, 4 months (intervention), and 12 months (post-intervention)
Change in weight overtime
3 secondary outcomes
Fasting Blood Glucose (mg/dl)
Time frame: Baseline, 4 months, 12 months
Hemoglobin A1c (%, HBA1c)
Time frame: Baseline, 4 months, 12 months
Body Mass Index (kg/m2)
Time frame: Baseline, 4 months, 12 months
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 8 Nov 2012.
- Derived from this study: PubMed 36962504Zoughbie DE, Ng TLJ, Thompson JY, Watson KT, Farraj R, Ding EL. Ramadan fasting and weight change trajectories: Time-varying association of weight during and after Ramadan in low-income and refugee populations. PLOS Glob Public Health. 2022 Oct 26;2(10):e0000371. doi: 10.1371/journal.pgph.0000371. eCollection 2022.
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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 Zoughbie, DPhil principal investigator
Microclinic International
Eric Ding, PhD principal investigator
Harvard University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microclinic in people with Diabetes Mellitus, Type II, run by Microclinic International at 2 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 3 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 8 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Weight (kg) (time frame: Baseline, 4 months (intervention), and 12 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 NCT01596244, 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 8 Nov 2012.