Community-Based Lifestyle Intervention for Diabetes Prevention in Arab Women (CBLI)

April 23, 2023 updated by: Donna R Zwas, Hadassah Medical Organization

Community-Based Lifestyle and Leadership Intervention for Primary, Secondary, and Tertiary Prevention of Diabetes in Women in the Arab Community

Arab women present increased risk for diabetes, with a 70% greater risk for adult-onset diabetes and a significantly younger age at onset compared with Jewish Israelis. In fact, the rate of diabetes for Arab women in Jerusalem is 4 times higher compared with their Jewish counterparts. Group lifestyle interventions such as the Diabetes Prevention Program (DPP) have documented effectiveness in preventing diabetes; however, many fail to demonstrate outcome maintenance. We predict that integrating leadership skills training into the gold standard DPP would improve the long-term outcome maintenance.

Stage 1: A pre-post study design will be utilized, where all community participants will be exposed to intervention components. The sample was selected from pre-existing groups in the local community center, based on their leadership potential.

phase 2: The second stage of the trial will not include the leadership component, but instead it will incorporate resiliency training and it aims to evaluate the effect of increased resiliency on the main outcomes including improvement in healthy behaviors such as adherence to Mediterranean diet and as well as a reduction in sedentary lifestyle and increased engagement in physical activity. In addition, resiliency training is likely to improve the maintenance of these behaviors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to design, implement and evaluate a community based lifestyle intervention that integrates a leadership skills training for Palestinian women living in East Jerusalem.

Stage 1: A pre-post study design will be utilized, where all community participants will be exposed to intervention components. The sample was selected from pre-existing groups in the local community center, based on their leadership potential. The Community-Based Lifestyle Intervention (CBLI) was developed by integrating leadership skill training to the gold standard Diabetes Prevention Program (DPP). According to social cognitive theory, engaging in lay leadership can help maintain health behaviors by providing leaders with social support, behavioral reinforcement, outcome expectancies, reciprocal determinism, and building self-efficacy. Fostering social change and empowering individuals, mobilizing community members is also an effective, low cost method for widespread impact on health behavior and health outcomes within the members' community. This is particularly true for women and minority populations. All intervention components were adapted to the specific culture, language, gender, and religious sensitivities of Palestinian female society.

The program will consist of 22 sessions presented by multiple professionals (nutritionists, exercise trainers, health coaches, and psychotherapists). Session content includes Mediterranean diet education, social support, food tasting and cooking, goal setting, self-monitoring, planning, conscious eating, leadership and lay leader training, initiative-taking, group dynamics, project design, community needs assessment, and project evaluation. The study is implemented in partnership with local community centers.

It is hypothesized that Arab women who participate in this community intervention will have improved - and maintained- healthy eating behaviors (i.e. Mediterranean Diet), reduced unhealthy eating behaviors (i.e. Western diet), increased engagement in physical activity and reduced risk of obesity (weight, BMI).

The second stage of the trial will not include the leadership component, but instead it will incorporate resiliency training and it aims to evaluate the effect of increased resiliency on the main outcomes including improvement in healthy behaviors such as adherence to Mediterranean diet and as well as a reduction in sedentary lifestyle and increased engagement in physical activity. In addition, resiliency training is likely to improve the maintenance of these behaviors.

Resiliency can be defined as a personal trait that contributes to the individual's ability to recover from stressful events. It is the ability to achieve, retain, or regain a level of physical or emotional health after illness or loss (bounce back). This characteristic is also considered a protective strength against mental problems, and the ability to effectively adapt to changes and recover from stressful events. Psychological stress is associated with increased risk of non-communicable diseases pose the greatest burden to public health, including heart disease. Additionally, people experiencing psychosocial challenges like isolation and life stress, are found to be less physically active, which is considered an independent risk factor for heart disease. Therefore, effective interventions that aim to reduce stress and anxiety and improve social connectedness are potential means of preventing and managing chronic diseases.

The present study (stage 2) will employ a cluster-randomized trial in which community centers will be assigned to either intervention group or attention control group. The intervention group will receive the CBLI content curriculum (as described above) in addition to the resiliency training (hence CBLI+RT). The attention control group will receive the core curriculum of the CBLI (CBLI-) only without the resiliency training. The sessions of the resiliency training will be replaced with sessions on health topics that do not contribute to our outcome (increased resiliency).

All intervention components were adapted to the specific culture, language, gender, and religious sensitivities of Palestinian female society.

It is hypothesized that Arab women who participate in this community intervention will have improved - and maintained- healthy eating behaviors (i.e. Mediterranean Diet), reduced unhealthy eating behaviors (i.e. Western diet), increased engagement in physical activity and reduced risk of obesity (weight, BMI).

The integration of positive psychology which focuses on individual's strengths through the resiliency training in the second stage of this trial, is hypothesized to be associated with improving-and maintain- healthy behaviors such as healthy diet, increased engagement in physical activity, and reducing unhealthy behaviors such as the consumption of western diet.

The first group will be assigned as a pilot study. This group will not be randomized but will receive the CBLI+RT in order to develop a resiliency training manual to be implemented in the following groups that will be assigned to receive RT in addition to the CBLI core curriculum.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Jerusalem, Israel, 95822
        • Recruiting
        • Beit-Safafa community center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Over age 18
  • Able to commit to the intervention timetable

Exclusion Criteria:

  • Younger than age 18
  • Unable to commit to the intervention timetable
  • Were not pregnant with expected delivery during the intervention
  • Were suffering from other serious mental or physical illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention-HPP
Community participants will participate in a group-based lifestyle intervention based on the CDC Diabetes Prevention Program, and adapted to the Arabic language, Arab culture, Mediterranean Diet, and adapted to include empowerment, leadership and emotion regulation.
Behavioral: intervention-HPP
Lifestyle intervention with presentations by multiple professionals (nutritionists, exercise trainers, and psychotherapists), this intervention will include Mediterranean diet education, physical activity, social support, food tasting and cooking, goal setting,and women's health topics. In addition, there will be training in leadership skills, community interventions, community needs assessment, intervention planning and outcomes assessment.
Experimental: CBLI+RT
based on randomization, group that will be assigned to CBLI+RT will receive the CBLI curriculum (as described in the intervention-HPP arm) in addition to the resiliency training
Behavioral: Community based intervention with resilience training
Lifestyle intervention with presentations by multiple professionals (nutritionists, exercise trainers, and psychotherapists), this intervention will include Mediterranean diet education, physical activity, social support, food tasting and cooking, goal setting, and women's health topics. In addition, there will be content targeting resilience training including: positive emotions, cognitive flexibility, life meaning, and active coping strategies.
Experimental: Attention control (CBLI-)
The attention control group will receive the core curriculum of the CBLI (as described in the intervention-HPP arm) only without the resiliency training. The sessions of the resiliency training will be replaced with sessions on health topics that do not contribute to our outcome (increased resiliency) (i.e. breast cancer, osteoporosis)
Behavioral: Attention-control
Lifestyle intervention with presentations by multiple professionals (nutritionists, exercise trainers, and psychotherapists), this intervention will include Mediterranean diet education, physical activity, social support, food tasting and cooking, goal setting,and women's health topics
Experimental: Pilot
This group will not be randomized. The group will receive the CBLI content (as described in the intervention-HPP arm) in addition to the resiliency training. The aim of this pilot is to create a resiliency training manual to be implemented in the following groups that will be assigned to receive the CBLI+RT
Behavioral: Pilot
Lifestyle intervention with presentations by multiple professionals (nutritionists, exercise trainers, and psychotherapists), this intervention will include Mediterranean diet education, physical activity, social support, food tasting and cooking, goal setting, and women's health topics. In addition, there will be content targeting resilience training including: positive emotions, cognitive flexibility, life meaning, and active coping strategies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mediterranean Diet adherence
Time Frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Will be assessed through Panagiotakos' Mediterranean Diet score (an 11 item self-report measure of adherence to the Mediterranean food pattern) which was adapted to Israeli diet and the Arab culture. Items assessing potato and alcohol consumption were removed and an item assessing nut consumption was added
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in physical activity engagement
Time Frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Will be assessed through self report of minutes engaged in vigorous and moderate physical via questionnaires.
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Plasma levels of Hemoglobin A1c (HbA1c)
Time Frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
The participants will be referred to their national health insurance in order to conduct a blood test for plasma levels of Hemoglobin A1c (HbA1c)
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Plasma levels of total cholesterol
Time Frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
The participants will be referred to their national health insurance in order to conduct a blood test for plasma levels of total cholesterol
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Plasma levels of HDL
Time Frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
The participants will be referred to their national health insurance in order to conduct a blood test for plasma levels of HDL
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Plasma levels of LDL
Time Frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
The participants will be referred to their national health insurance in order to conduct a blood test for plasma levels of LDL
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Plasma levels of triglycerides
Time Frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
The participants will be referred to their national health insurance in order to conduct a blood test for plasma levels of triglycerides
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Body Mass Index (BMI)
Time Frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
BMI will be calculated by measuring weight and height for each participant.
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Blood Pressure (BP)
Time Frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Will be measured using standard procedures with an electronic BP apparatus and the recorded measurement is the average of 2 measurements taken in the seated position
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Cardiovascular Disease Knowledge
Time Frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Will be assessed through self report questionnaire based on the American Heart Association's knowledge survey items
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Stages of Change for targeted health behaviors
Time Frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Will be assessed through self report questionnaire
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Leadership Self-Efficacy
Time Frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Will be assessed through self report questionnaire
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Resilience
Time Frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Resilience will be measured through the validated 10 items Connor-Davidson Resilience Scale (CD-RISC-10)
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Sense of Coherence
Time Frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Sense of coherence will be measured through the Sense of Coherence 13-item scale
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Self-Rated health
Time Frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Self reported status of health will be measured using the Self-Rated health questionnaire
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Donna Zwas, MD, MPH, Hadassah University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2016

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

June 25, 2017

First Submitted That Met QC Criteria

November 30, 2017

First Posted (Actual)

December 2, 2017

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 23, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 123NDP-HMO-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

yes, to investigators with certified GCP upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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