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NCT Number: NCT03358797

Community-Based Lifestyle Intervention for Diabetes Prevention in Arab Women

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beit-Safafa community center

Jerusalem, 95822, Israel

Location status: Recruiting

Location contact

director of the center

CONTACT

[email protected]

02690717

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Attention-control

Behavioral

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

Community based intervention with resilience training

Behavioral

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.

intervention-HPP

Behavioral

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.

Pilot

Behavioral

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.

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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)

  12. 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

  13. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Donna Zwas, MD, MPH

CONTACT

[email protected]

+9722-677-9451

Nisreen Agbaria, RN, MSc

CONTACT

[email protected]

+972 52-966-8796

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

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

Acronym: CBLI

Important dates

Study start
2016
Primary completion
2025
Study completion
2026
First posted
Dec 2, 2017
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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