Microclinic Social Network Behavioral Health Trial in Jordan

NCT01818674 | Completed

• 1 other identifier: WDF2010-2014
• Study Type: interventional
• Target: 914
• Locations: 1 country
• Sites: 3

Brief 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. 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).

Conditions

Diabetes Mellitus, Type 2; Obesity; Hypertension; Hyperglycemia; Blood Pressure; Hyperglycaemia (Diabetic); Body Weight; Weight Loss; Weight, Body; Weight Change Trajectory; Weight Change, Body; Weight Gain; Blood Pressure, High; Social Behavior; Behavior, Health; Lifestyle Risk Reduction; Lifestyle, Healthy; Diabetes; Diabetes Mellitus; Glucose, High Blood

Keywords

social network; microclinic; middle east; jordan; intervention

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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)

  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.

  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

  Change from baseline, at 6 months, at 2 years

• Relative changes in fasting glucose between individual trial arms

  Change from baseline, at 6 months, at 2 years

• Relative changes in HbA1c between individual trial arms

  Change from baseline, at 6 months, at 2 years

• Relative changes in blood pressure between individual trial arms

  Change from baseline, at 6 months, at 2 years

Study Arms (3)

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)

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)

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.

Interventions

Microclinic Behavioral Health Full Program (education curriculum in classroom setting, plus full social interaction program) BEHAVIORAL

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.

Also known as: Group A

Group A - Microclinic Behavioral Health Enhanced Program

Microclinic Behavioral Health Basic Program (education-only in classroom setting; no structured social interactions) BEHAVIORAL

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.

Also known as: Group B

Group B - Microclinic Behavioral Health Basic Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Microclinic International: lead
• Royal Health Awareness Society (RHAS): collaborator
• Jordanian Ministry of Health (MoH): collaborator

Study Sites (3)

Abu Nseir Ministry of Health Center

Amman, Jordan

Location

Kreibet Al Souq Ministry of Health Center

Amman, Jordan

Location

Naour Ministry of Health Center

Amman, Jordan

Location

Related Publications (1)

• 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.

  PMID: 38507441 DERIVED

Related Links

• Microclinic International homepage

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Hypertension; Hyperglycemia; Body Weight; Weight Loss; Body-Weight Trajectory; Body Weight Changes; Weight Gain; Social Behavior; Health Behavior; Risk Reduction Behavior; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Daniel E Zoughbie, D.Phil.

  Microclinic International

  PRINCIPAL INVESTIGATOR

• Eric L Ding, Sc.D.

  New England Complex Systems Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2013
• First Posted: March 26, 2013
• Study Start: January 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: October 1, 2019
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

JO (3)