NCT01596244

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

November 8, 2012

Status Verified

November 1, 2012

Enrollment Period

3 years

First QC Date

May 9, 2012

Last Update Submit

November 7, 2012

Conditions

Diabetes Mellitus, Type II

Keywords

Diabetes Mellitus, Type IIDisease managementChronic diseasePrevention and controlEducation

Outcome Measures

Primary Outcomes (1)

  • Weight (kg)

    Change in weight overtime

    Baseline, 4 months (intervention), and 12 months (post-intervention)

Secondary Outcomes (3)

  • Fasting Blood Glucose (mg/dl)

    Baseline, 4 months, 12 months

  • Hemoglobin A1c (%, HBA1c)

    Baseline, 4 months, 12 months

  • Body Mass Index (kg/m2)

    Baseline, 4 months, 12 months

Study Arms (1)

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.

Behavioral: Microclinic

Interventions

MicroclinicBEHAVIORAL

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.

Microclinics training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ein El-Basha Ministry of Health Center

Amman, Jordan

Location

Jabl Nasr Ministry of Health Center

Amman, Jordan

Location

Related Publications (1)

  • 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.

    PMID: 36962504DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Chronic Disease

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Zoughbie, DPhil

    Microclinic International

    PRINCIPAL INVESTIGATOR

  • Eric Ding, PhD

    Harvard University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2012

First Posted

May 10, 2012

Study Start

April 1, 2008

Primary Completion

April 1, 2011

Study Completion

August 1, 2012

Last Updated

November 8, 2012

Record last verified: 2012-11

Locations

JO(2)