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

NCT04143737 | Completed

• 1 other identifier: ZU456-HMO-CTIL
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes; Cardiovascular Diseases; Health Behavior

Keywords

Community-based intervention; Arab women; East jerusalem; Diabetes prevention; Lifestyle intervention; Quasi-Experiment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change in body Mass Index (BMI)

  6 months after intervention initiation

• Change in Plasma levels of Hemoglobin A1c (HbA1c)

  6 months after intervention initiation

• Change in Plasma levels of Glucose, HDL, LDL, triglycerides, and total cholesterol

  6 months after intervention initiation

• Change in Blood pressure (BP)

  6 months after intervention initiation

• Change in Cardiovascular disease knowledge

  6 months after intervention initiation

Study Arms (2)

Intervention

OTHER

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

Control

NO INTERVENTION

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.

Interventions

Healthy lifestyle intervention BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 25 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 25 and above
• Able to commit to the program timetable

You may not qualify if:

• Age younger than25
• Unable to commit to the intervention timetable
• Pregnant with expected delivery during the intervention
• Women with serious mental or physical illness

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Related Publications (9)

• Ackermann RT. Bridging the why and the how of clinical-community integration. Am J Prev Med. 2013 Oct;45(4):526-9. doi: 10.1016/j.amepre.2013.07.003. No abstract available.

  PMID: 24050431 BACKGROUND

• Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. doi: 10.2337/diacare.25.12.2165.

  PMID: 12453955 BACKGROUND

• Chiuve SE, Cook NR, Shay CM, Rexrode KM, Albert CM, Manson JE, Willett WC, Rimm EB. Lifestyle-based prediction model for the prevention of CVD: the Healthy Heart Score. J Am Heart Assoc. 2014 Nov 14;3(6):e000954. doi: 10.1161/JAHA.114.000954.

  PMID: 25398889 BACKGROUND

• Chan JC, Malik V, Jia W, Kadowaki T, Yajnik CS, Yoon KH, Hu FB. Diabetes in Asia: epidemiology, risk factors, and pathophysiology. JAMA. 2009 May 27;301(20):2129-40. doi: 10.1001/jama.2009.726.

  PMID: 19470990 BACKGROUND

• Fianu A, Bourse L, Naty N, Le Moullec N, Lepage B, Lang T, Favier F. Long-Term Effectiveness of a Lifestyle Intervention for the Primary Prevention of Type 2 Diabetes in a Low Socio-Economic Community--An Intervention Follow-Up Study on Reunion Island. PLoS One. 2016 Jan 5;11(1):e0146095. doi: 10.1371/journal.pone.0146095. eCollection 2016.

  PMID: 26731676 BACKGROUND

• 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.

  PMID: 22050554 BACKGROUND

• 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.

  PMID: 23367733 BACKGROUND

• 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.

  PMID: 16457990 BACKGROUND

• 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.

  PMID: 26534856 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases; Health Behavior

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Quasi-experimental, pre-post study

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: October 29, 2019
• Study Start: March 7, 2016
• Primary Completion: September 21, 2016
• Study Completion: January 17, 2017
• Last Updated: October 29, 2019

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Will be available with publication
• Access Criteria: GCP certification and review of appropriate research interest