Overview

This trial is active, not recruiting.

Conditions diabetes mellitus, type 2, obesity
Treatments microclinic social network behavioral health program, modified microclinic behavioral health program without social network components (education curriculum only), risk factor measurement
Sponsor Microclinic International
Collaborator Royal Health Awareness Society (RHAS)
Start date January 2012
End date December 2015
Trial size 500 participants
Trial identifier NCT01818674, WDF2010-2014

Summary

The "Microclinic Social Network Behavioral Health Trial for Obesity and Metabolic Risk Factor Control in Jordan" spans 51 months and aims to test the effectiveness of the Microclinic Social Network Behavioral Health Program in influencing lifestyle behavioral risk factors to improve diabetes management that effect weight and metabolic outcomes through social networks. The Microclinic Social Network Behavioral Health Program provides microclinic (MC) groups—consisting of approximately 2-8 individuals from pre-existing social networks (friends, relatives, coworkers, neighbors, etc)—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. 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.

This Microclinic Social Network Behavioral Health Trial was established in collaboration with the Royal Health Awareness Society (RHAS) and the Jordanian Ministry of Health (MoH).

This objective of the Microclinic Social Network Behavioral Health Trial, the first randomized control study of its kind, is to test the effectiveness of the Microclinic Social Network Behavioral Health Program. The study will yield valuable information on the impact of social relationships with diabetes education on weight and metabolic control among individuals with type 2 diabetes.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The Microclinic Group A is the group receiving the Microclinic Social Network Behavioral Health Program in microclinic groups (groups of 2-8 friends or family members).
microclinic social network behavioral health program
An approximately 7-month participatory program (sessions and educational materials) that will 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 for ~28 participants.
risk factor measurement
Measurement of metabolic risk factors for obesity and diabetes as described by the primary and secondary outcomes
(Active Comparator)
The group B receives a modified Microclinic Behavioral Health Program without social network components (education curriculum only) as individuals in a class.
modified microclinic behavioral health program without social network components (education curriculum only)
This program will be provided to Group B and will increase participants knowledge about diabetes self-management. For the education program in group B there are no group-based or team-building activities, group goal setting, and class is pure lecture style with no class participation.
risk factor measurement
Measurement of metabolic risk factors for obesity and diabetes as described by the primary and secondary outcomes
(Other)
These are considered the control group who are receiving standard care. Subjects in this group will only have risk factor measurements obtained through clinic screenings only; they will not participate in program activities.
risk factor measurement
Measurement of metabolic risk factors for obesity and diabetes as described by the primary and secondary outcomes

Primary Outcomes

Measure
Change from baseline in obesity measures at the the end of the program
time frame: 4 months
Change from baseline in hyperglycemia measures at the end of the program
time frame: 4 months

Secondary Outcomes

Measure
Long-term change in obesity from baseline
time frame: 16 months and an average of 2 years from baseline
Long-term change in hyperglycemia measures from baseline
time frame: 16 months and an average of 2 years from baseline
Change from baseline in blood pressure at the end of program
time frame: 4 months
Long-term change in blood pressure from baseline
time frame: 16 months and average of two years after baseline
Change in the quality of social ties built during the program
time frame: 4 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - In order to be included, participants must meet the following criteria: 1) diagnosed with type 2 diabetes, pre-diabetes, or at risk for diabetes 2) are at least the age of 18, 3) live in the catchment area of the study, 4) seeds or individuals specifically recruited by the research team, and 5) provide informed consent to participate. Exclusion Criteria: - The following criteria excludes patients: 1) participants who are not diagnosed with type 2 diabetes, pre-diabetes, or at-risk for diabetes, 2) are not able to provide informed consent due to mental conditions, 3) participants under the age of 18 and 4) 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.

Additional Information

Official title Microclinic Social Network Behavioral Health Trial for Obesity and Metabolic Risk Factor Control in Jordan
Principal investigator Daniel Zoughbie, DPhil
Description I. Objectives 1. To assess the effectiveness of the Microclinic Social Network Behavioral Health Program, on biomedical, behavioral, knowledge, and psychosocial outcomes compared to patients receiving a modified Microclinic Behavioral Health Program without the social network components. 2. To assess the effectiveness of the Microclinic Social Network Behavioral Health Program, on biomedical, behavioral, knowledge, and psychosocial outcomes compared to patients receiving standard care. 3. To assess the impact of utilizing existing social networks in improving biomedical and behavioral outcomes. 4. To assess the long-term impact of Microclinic Social Network Behavioral Health Program on improving sustained clinical, behavioral, knowledge, and psychosocial outcomes. II. Study Design Randomized Control Study: This study is a randomized control study that will aim to recruit 500 female and male 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 (n=~300 as Group A), a group who will receive a modified Microclinic Behavioral Health Program without the social network components (n=~100 as Group B) , and controls receiving standard care (n=~100 as Group C). III. Study Procedures 1. 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. 1. Phase 1. Recruitment: Outreach strategies to recruit patients at risk for diabetes and with Type 2 diabetes include: - 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. - 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 will be contacted by phone or referred to the trial in person during their visit to the health center and asked if they would be willing to participate. 2. Phase 2. Randomization: Patients registering to participate in the trial will be entered into a sampling pool (n=~140 nodes - those originally recruited who then bring friends and family - per cohort) database that contains all the names of potential participants and unique identifying numbers for each person. Computer generated stratified randomization will occur on nodes to three study arms: a) Group A receiving the Microclinic Social Network Behavioral Health Program, b) Group B receiving a modified Microclinic Behavioral Health Program that has the same educational curriculum but without social network components and participants attend sessions as individuals, or c) Group C receiving no intervention and therefore, standard care as the control group. 3. Microclinic Groups: Microclinics are self-selected groups of family and friends who are diabetic, pre-diabetic, or at risk for diabetes and come to meet regularly to support one another in setting and meeting goals for improving their health, to learn tools for managing diabetes, and to share much-needed medical supplies and equipment. Only participants assigned to the group A will be asked to bring in friends and/or family members with Type 2 diabetes, pre-diabetes, or at risk for diabetes to participate in the Microclinic Social Network Behavioral Health Program together. In comparison, participants assigned to group B and group C will have data collected as individuals. 2. The Microclinic Social Network Behavioral Health Program (approximately 7 months) Only Group A will receive this program. Control group B will receive a modified version that contains the same educational curriculum but does not emphasize the importance of social support and social networks. Control group C will receive standard care and only be followed-up for parallel measurements in the same schedule. Group A participants receiving the Microclinic Social Network Behavioral Health Program will be followed by a trained Project Nurse and receive an approximately 7-month program (sessions and educational materials) that will increase the knowledge and skills in diabetes self-management and peer support and monitoring. The curriculum includes sessions on the 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 session will provide 2-3 hours of discussion to foster active class participation and engagement for ~28 participants. 3. Evaluation and Data Collection A critical component of this project is systematic data gathering, analysis, and evaluation aimed at assessing the short and long term efficacy, sustainability and feasibility of the Microclinic Social Network Behavioral Health Program. The program evaluation will collect demographic, socioeconomic, medical history, medical data, behavioral data, psychosocial data, and social network data from all participants during the program as well as post-program (up to 2 years after baseline). Participants are assigned an identification number during recruitment and all identifying participants characteristics are kept a secure computer database that is both firewalled and password protected.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Microclinic International.