Community-Based Lifestyle Intervention for Primary and Secondary Prevention of Diabetes in Arab Women in East-Jerusalem

Study Overview
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Brief Summary
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Given the extremely high incidence of diabetes in Arab women and the current lack of interventions, all non-diabetic women can be considered at risk and warrant secondary prevention. Creating an effective community-based primary and secondary diabetes prevention program has the potential for nationwide reduction of health disparities for Arab women. The purpose of this study was to investigate the effectiveness of a lifestyle intervention in reducing risky health behaviors and thus reducing modifiable risk factors associated with diabetes and cardiovascular diseases, through dietary modification, adherence to healthy low-caloric, low-fat diet and engaging in physical activity.

Detailed Description
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Given the extremely high incidence of diabetes in Arab women and the current lack of interventions, all non-diabetic women can be considered at risk and warrant secondary prevention. The purpose of this study was to investigate the effectiveness of lifestyle intervention in reducing risky health behaviors and thus reducing modifiable risk factors associated with diabetes and cardiovascular diseases, through dietary modification, adherence to healthy low-caloric, low-fat diet and engaging in physical activity. Methods: The invistigators will conduct a quasi-experimental, pre-post intervention study between to investigate the effectiveness of community based intervention to change lifestyle habits and consequently reduce the modifiable risk factors for developing diabetes at all levels of prevention. All members of two targeted Arab women's community centers in East-Jerusalem will be invited to participate in the study. Potential participants will be interviewed for eligibility (over age 25, able to commit to the intervention timetable, and precluding pregnancy or serious mental and physical illness). Participants who will be included in the control group will not receive any intervention. The intervention group will be located in one community center in Zur-Baher neighborhood, and the control group will be located in one community center in the old city of Jerusalem. Data will be collected from both groups. Intervention: The Community-Based Lifestyle Intervention (CBLI) was developed based on the gold standard Diabetes Prevention Program (DPP) and adapting all intervention components to the specific culture, language, gender, and religious sensitivities of Palestinian female society. The intervention consisted of 20 weekly sessions and will be taught by professional facilitators (nutritionists, exercise trainers, health coaches, and psychotherapists). The DPP's lifestyle curriculum includes sessions on nutrition, physical activity, stress management skills, and self-monitoring and was culturally adapted, translated into Arabic, and gender tailored.

Official Title
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Community-Based Lifestyle Intervention for Primary and Secondary Prevention of Diabetes in Arab Women in East-Jerusalem, A Quasi-experimental Study.

Conditions
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Diabetes, Cardiovascular Diseases, Health Behavior

Intervention / Treatment
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* Behavioral: Healthy lifestyle intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 25 and above Able to commit to the program timetable Exclusion Criteria: Age younger than25 Unable to commit to the intervention timetable Pregnant with expected delivery during the intervention Women with serious mental or physical illness

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Quasi-experimental, pre-post study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention<br>38 women participated in the intervention group which was located in a community center in Zur-Baher neighborhood. The intervention consisted of 20 weekly sessions on nutrition, physical activity, stress management skills, and self-monitoring. All taught by professional facilitators (nutritionists, exercise trainers, health coaches, and psychotherapists). Baseline data was collected | Behavioral: Healthy lifestyle intervention<br>* 38 women participated in the intervention group which was located in a community center in Zur-Baher neighborhood. The intervention consisted of 20 weekly sessions on nutrition, physical activity, stress management skills, and self-monitoring. All taught by professional facilitators (nutritionists, exercise trainers, health coaches, and psychotherapists). Baseline data was collected<br>|
| No Intervention: Control<br>22 women participated in the control group. They were recruited from a community center in the old city of Jerusalem and did not receive any intervention. Baseline data was collected. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to Mediterranean diet | Adherence to Mediterranean Diet- Eating behaviors will be assessed through self-reported questionnaire adapted from the Attica study. The questions include an assessment of daily average consumption of whole grains, vegetables, fruits, legumes, and low-fat dairy products. The questionnaire includes also food items assessing the consumption of western diet including sweets, sweet drinks and salty snacks. These questions were adapted from the following study: A Western dietary pattern is associated with higher blood pressure in Iranian adolescents. European Journal of Nutrition 2017 Feb:56(1)399-408. | 6 months after intervention initiation | 
| Change in average daily steps- measured by Pedometer | The participants in the intervention group were given a pedometer and weekly step data were collected by the research team. | 6 months after intervention initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body Mass Index (BMI) | BMI will be calculated by measuring weight and height for each participant. weight will be measured in kilograms. Height was measured to the nearest 0.1 cm. Body Mass Index (BMI) will be calculated using the formula of weight in kg divided by height in m2 (kg/m2). | 6 months after intervention initiation | 
| Change in Plasma levels of Hemoglobin A1c (HbA1c) | measured using capillary whole blood obtained on finger stick, through a cartridge-based latex agglutination inhibition assay through finger stick on the Cobas B101 point of care device | 6 months after intervention initiation | 
| Change in Plasma levels of Glucose, HDL, LDL, triglycerides, and total cholesterol | The participants will be referred to their national health insurance in order to conduct a blood test for plasma levels of HDL, LDL, triglycerides, and total cholesterol | 6 months after intervention initiation | 
| Change in Blood pressure (BP) | 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 | 6 months after intervention initiation | 
| Change in Cardiovascular disease knowledge | Will be assessed through self report questionnaire based on the American Heart Association's knowledge survey items | 6 months after intervention initiation | 
| Change in Leadership self-efficacy scale | Leadership self-efficacy will be assessed through self report questionnaire. This questionnaire was adapted from a scale used in previous study by the Brookdale Institute in Israel, with similar objectives of empowering and promoting female lay health leaders in the community to advance women's health. The questionnaire consists of 9 items. Participants were asked to rate their level of confidence that they can perform the tasks defined by the leadership component objectives. Respondents select from a 4-point scale varying from 1 = a little confident to 4 = very confident. The sub-scales will be summed and average score will be calculated. higher values represent a better outcome. | 6 months after intervention initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community-based intervention, Arab women, East jerusalem, Diabetes prevention, Lifestyle intervention, Quasi-Experiment