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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04143737
Recruitment Status : Completed
First Posted : October 29, 2019
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE November 29, 2018
First Posted Date  ICMJE October 29, 2019
Last Update Posted Date October 29, 2019
Actual Study Start Date  ICMJE March 7, 2016
Actual Primary Completion Date September 21, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2019)
  • Adherence to Mediterranean diet [ Time Frame: 6 months after intervention initiation ]
    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.
  • Change in average daily steps- measured by Pedometer [ Time Frame: 6 months after intervention initiation ]
    The participants in the intervention group were given a pedometer and weekly step data were collected by the research team.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2019)
  • Change in body Mass Index (BMI) [ Time Frame: 6 months after intervention initiation ]
    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).
  • Change in Plasma levels of Hemoglobin A1c (HbA1c) [ Time Frame: 6 months after intervention initiation ]
    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
  • Change in Plasma levels of Glucose, HDL, LDL, triglycerides, and total cholesterol [ Time Frame: 6 months after intervention initiation ]
    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
  • Change in Blood pressure (BP) [ Time Frame: 6 months after intervention initiation ]
    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
  • Change in Cardiovascular disease knowledge [ Time Frame: 6 months after intervention initiation ]
    Will be assessed through self report questionnaire based on the American Heart Association's knowledge survey items
  • Change in Leadership self-efficacy scale [ Time Frame: 6 months after intervention initiation ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Community-Based Lifestyle Intervention for Primary and Secondary Prevention of Diabetes in Arab Women in East-Jerusalem
Official Title  ICMJE Community-Based Lifestyle Intervention for Primary and Secondary Prevention of Diabetes in Arab Women in East-Jerusalem, A Quasi-experimental Study.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Quasi-experimental, pre-post study
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Diabetes
  • Cardiovascular Diseases
  • Health Behavior
Intervention  ICMJE Behavioral: Healthy lifestyle intervention
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
Study Arms  ICMJE
  • Intervention
    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: Behavioral: Healthy lifestyle intervention
  • No Intervention: Control
    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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 27, 2019)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 17, 2017
Actual Primary Completion Date September 21, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04143737
Other Study ID Numbers  ICMJE ZU456-HMO-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Plan is to share de-identified IPD
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Will be available with publication
Access Criteria: GCP certification and review of appropriate research interest
Responsible Party Hadassah Medical Organization
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hadassah Medical Organization
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP