Clinical trial NCT03358797: Community-Based Lifestyle Intervention for Diabetes Prevention in Arab Women
Official title: Community-Based Lifestyle and Leadership Intervention for Primary, Secondary, and Tertiary Prevention of Diabetes in Women in the Arab Community
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Health Behaviors
Keywords: Community-based Intervention
Lifestyle intervention
Diabetes prevention
Leadership
Resilience
Women's health
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stage 1: interventional, Pre - Post study, with quasi-experimental comparison group Stage 2: interventional, Pre - Post study, with cluster randomization (Pilot study to develop the resiliency training manual will be part of stage 2)
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Mediterranean Diet adherence
timeFrame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
measure: Change in physical activity engagement
timeFrame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Secondary outcomes:
measure: Change in Plasma levels of Hemoglobin A1c (HbA1c)
timeFrame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
measure: Change in Plasma levels of total cholesterol
timeFrame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
measure: Change in Plasma levels of HDL
timeFrame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
measure: Change in Plasma levels of LDL
timeFrame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
measure: Change in Plasma levels of triglycerides
timeFrame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
measure: Change in Blood Pressure (BP)
timeFrame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
measure: Change in Cardiovascular Disease Knowledge
timeFrame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
measure: Stages of Change for targeted health behaviors
timeFrame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
measure: Change in Leadership Self-Efficacy
timeFrame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
measure: Change in Resilience
timeFrame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
measure: Change in Sense of Coherence
timeFrame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
measure: Change in Self-Rated health
timeFrame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Beit-Safafa community center
Study officials:
affiliation: Hadassah University Medical Center
name: Donna Zwas, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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