Community-Based Lifestyle and Leadership Intervention for Primary, Secondary, and Tertiary Prevention of Diabetes in Women in the Arab Community
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change in physical activity engagement
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Over age 18
- •Able to commit to the intervention timetable
排除标准
- •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
结局指标
主要结局
Change in physical activity engagement
时间窗: 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.
Change in Mediterranean Diet adherence
时间窗: 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
次要结局
- Change in Plasma levels of LDL(Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later))
- Change in Plasma levels of HDL(Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later))
- Change in 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 triglycerides(Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later))
- Change in Cardiovascular Disease Knowledge(Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later))
- Stages of Change for targeted health behaviors(Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later))
- Change in Plasma levels of total cholesterol(Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later))
- Change in Blood Pressure (BP)(Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later))
- Change in Body Mass Index (BMI)(Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later))
- Change in Resilience(Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later))
- Change in Leadership Self-Efficacy(Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later))
- Change in Sense of Coherence(Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later))
- Change in Self-Rated health(Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later))
研究者
Donna R Zwas
Director, Linda Joy Pollin Cardiovascular Wellness Center for Women
Hadassah Medical Organization