Clinical trial NCT04143737: Community-Based Lifestyle Intervention for Primary and Secondary Prevention of Diabetes in Arab Women in East-Jerusalem
Official title: Community-Based Lifestyle Intervention for Primary and Secondary Prevention of Diabetes in Arab Women in East-Jerusalem, A Quasi-experimental Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Cardiovascular Diseases
Health Behavior
Keywords: Community-based intervention
Arab women
East jerusalem
Diabetes prevention
Lifestyle intervention
Quasi-Experiment
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental, pre-post study
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to Mediterranean diet
timeFrame: 6 months after intervention initiation
measure: Change in average daily steps- measured by Pedometer
timeFrame: 6 months after intervention initiation
Secondary outcomes:
measure: Change in body Mass Index (BMI)
timeFrame: 6 months after intervention initiation
measure: Change in Plasma levels of Hemoglobin A1c (HbA1c)
timeFrame: 6 months after intervention initiation
measure: Change in Plasma levels of Glucose, HDL, LDL, triglycerides, and total cholesterol
timeFrame: 6 months after intervention initiation
measure: Change in Blood pressure (BP)
timeFrame: 6 months after intervention initiation
measure: Change in Cardiovascular disease knowledge
timeFrame: 6 months after intervention initiation
measure: Change in Leadership self-efficacy scale
timeFrame: 6 months after intervention initiation
Other outcomes:
Locations:
Study officials:
References:
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citation: Kalter-Leibovici O, Chetrit A, Lubin F, Atamna A, Alpert G, Ziv A, Abu-Saad K, Murad H, Eilat-Adar S, Goldbourt U. Adult-onset diabetes among Arabs and Jews in Israel: a population-based study. Diabet Med. 2012 Jun;29(6):748-54. doi: 10.1111/j.1464-5491.2011.03516.x.
citation: Idilbi NM, Barhana M, Milman U, Carel RS. [Diabetes mellitus and cancer: the different expression of these diseases in Israeli Arabs and Jews]. Harefuah. 2012 Nov;151(11):625-8, 654. Hebrew.
citation: Panagiotakos DB, Chrysohoou C, Pitsavos C, Stefanadis C. Association between the prevalence of obesity and adherence to the Mediterranean diet: the ATTICA study. Nutrition. 2006 May;22(5):449-56. doi: 10.1016/j.nut.2005.11.004. Epub 2006 Feb 2.
citation: Hojhabrimanesh A, Akhlaghi M, Rahmani E, Amanat S, Atefi M, Najafi M, Hashemzadeh M, Salehi S, Faghih S. A Western dietary pattern is associated with higher blood pressure in Iranian adolescents. Eur J Nutr. 2017 Feb;56(1):399-408. doi: 10.1007/s00394-015-1090-z. Epub 2015 Nov 3.