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Community-Based Lifestyle Intervention for Diabetes Prevention in Arab Women (CBLI)

Primary Purpose

Diabetes, Health Behaviors

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Attention-control
Community based intervention with resilience training
intervention-HPP
Pilot
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring Community-based Intervention, Lifestyle intervention, Diabetes prevention, Leadership, Resilience, Women's health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Over age 18
  • Able to commit to the intervention timetable

Exclusion Criteria:

  • 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

Sites / Locations

  • Beit-Safafa community centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

intervention-HPP

CBLI+RT

Attention control (CBLI-)

Pilot

Arm Description

Community participants will participate in a group-based lifestyle intervention based on the CDC Diabetes Prevention Program, and adapted to the Arabic language, Arab culture, Mediterranean Diet, and adapted to include empowerment, leadership and emotion regulation.

based on randomization, group that will be assigned to CBLI+RT will receive the CBLI curriculum (as described in the intervention-HPP arm) in addition to the resiliency training

The attention control group will receive the core curriculum of the CBLI (as described in the intervention-HPP arm) only without the resiliency training. The sessions of the resiliency training will be replaced with sessions on health topics that do not contribute to our outcome (increased resiliency) (i.e. breast cancer, osteoporosis)

This group will not be randomized. The group will receive the CBLI content (as described in the intervention-HPP arm) in addition to the resiliency training. The aim of this pilot is to create a resiliency training manual to be implemented in the following groups that will be assigned to receive the CBLI+RT

Outcomes

Primary Outcome Measures

Change in Mediterranean Diet adherence
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
Change in physical activity engagement
Will be assessed through self report of minutes engaged in vigorous and moderate physical via questionnaires.

Secondary Outcome Measures

Change in Plasma levels of Hemoglobin A1c (HbA1c)
The participants will be referred to their national health insurance in order to conduct a blood test for plasma levels of Hemoglobin A1c (HbA1c)
Change in Plasma levels of total cholesterol
The participants will be referred to their national health insurance in order to conduct a blood test for plasma levels of total cholesterol
Change in Plasma levels of HDL
The participants will be referred to their national health insurance in order to conduct a blood test for plasma levels of HDL
Change in Plasma levels of LDL
The participants will be referred to their national health insurance in order to conduct a blood test for plasma levels of LDL
Change in Plasma levels of triglycerides
The participants will be referred to their national health insurance in order to conduct a blood test for plasma levels of triglycerides
Change in Body Mass Index (BMI)
BMI will be calculated by measuring weight and height for each participant.
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
Change in Cardiovascular Disease Knowledge
Will be assessed through self report questionnaire based on the American Heart Association's knowledge survey items
Stages of Change for targeted health behaviors
Will be assessed through self report questionnaire
Change in Leadership Self-Efficacy
Will be assessed through self report questionnaire
Change in Resilience
Resilience will be measured through the validated 10 items Connor-Davidson Resilience Scale (CD-RISC-10)
Change in Sense of Coherence
Sense of coherence will be measured through the Sense of Coherence 13-item scale
Change in Self-Rated health
Self reported status of health will be measured using the Self-Rated health questionnaire

Full Information

First Posted
June 25, 2017
Last Updated
April 23, 2023
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT03358797
Brief Title
Community-Based Lifestyle Intervention for Diabetes Prevention in Arab Women
Acronym
CBLI
Official Title
Community-Based Lifestyle and Leadership Intervention for Primary, Secondary, and Tertiary Prevention of Diabetes in Women in the Arab Community
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 29, 2016 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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. Resiliency can be defined as a personal trait that contributes to the individual's ability to recover from stressful events. It is the ability to achieve, retain, or regain a level of physical or emotional health after illness or loss (bounce back). This characteristic is also considered a protective strength against mental problems, and the ability to effectively adapt to changes and recover from stressful events. Psychological stress is associated with increased risk of non-communicable diseases pose the greatest burden to public health, including heart disease. Additionally, people experiencing psychosocial challenges like isolation and life stress, are found to be less physically active, which is considered an independent risk factor for heart disease. Therefore, effective interventions that aim to reduce stress and anxiety and improve social connectedness are potential means of preventing and managing chronic diseases. The present study (stage 2) will employ a cluster-randomized trial in which community centers will be assigned to either intervention group or attention control group. The intervention group will receive the CBLI content curriculum (as described above) in addition to the resiliency training (hence CBLI+RT). The attention control group will receive the core curriculum of the CBLI (CBLI-) only without the resiliency training. The sessions of the resiliency training will be replaced with sessions on health topics that do not contribute to our outcome (increased resiliency). All intervention components were adapted to the specific culture, language, gender, and religious sensitivities of Palestinian female society. 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 integration of positive psychology which focuses on individual's strengths through the resiliency training in the second stage of this trial, is hypothesized to be associated with improving-and maintain- healthy behaviors such as healthy diet, increased engagement in physical activity, and reducing unhealthy behaviors such as the consumption of western diet. The first group will be assigned as a pilot study. This group will not be randomized but will receive the CBLI+RT in order to develop a resiliency training manual to be implemented in the following groups that will be assigned to receive RT in addition to the CBLI core curriculum.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Health Behaviors
Keywords
Community-based Intervention, Lifestyle intervention, Diabetes prevention, Leadership, Resilience, Women's health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Stage 1: interventional, Pre - Post study, with quasi-experimental comparison group Stage 2: interventional, Pre - Post study, with cluster randomization (Pilot study to develop the resiliency training manual will be part of stage 2)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention-HPP
Arm Type
Experimental
Arm Description
Community participants will participate in a group-based lifestyle intervention based on the CDC Diabetes Prevention Program, and adapted to the Arabic language, Arab culture, Mediterranean Diet, and adapted to include empowerment, leadership and emotion regulation.
Arm Title
CBLI+RT
Arm Type
Experimental
Arm Description
based on randomization, group that will be assigned to CBLI+RT will receive the CBLI curriculum (as described in the intervention-HPP arm) in addition to the resiliency training
Arm Title
Attention control (CBLI-)
Arm Type
Experimental
Arm Description
The attention control group will receive the core curriculum of the CBLI (as described in the intervention-HPP arm) only without the resiliency training. The sessions of the resiliency training will be replaced with sessions on health topics that do not contribute to our outcome (increased resiliency) (i.e. breast cancer, osteoporosis)
Arm Title
Pilot
Arm Type
Experimental
Arm Description
This group will not be randomized. The group will receive the CBLI content (as described in the intervention-HPP arm) in addition to the resiliency training. The aim of this pilot is to create a resiliency training manual to be implemented in the following groups that will be assigned to receive the CBLI+RT
Intervention Type
Behavioral
Intervention Name(s)
Attention-control
Intervention Description
Lifestyle intervention with presentations by multiple professionals (nutritionists, exercise trainers, and psychotherapists), this intervention will include Mediterranean diet education, physical activity, social support, food tasting and cooking, goal setting,and women's health topics
Intervention Type
Behavioral
Intervention Name(s)
Community based intervention with resilience training
Intervention Description
Lifestyle intervention with presentations by multiple professionals (nutritionists, exercise trainers, and psychotherapists), this intervention will include Mediterranean diet education, physical activity, social support, food tasting and cooking, goal setting, and women's health topics. In addition, there will be content targeting resilience training including: positive emotions, cognitive flexibility, life meaning, and active coping strategies.
Intervention Type
Behavioral
Intervention Name(s)
intervention-HPP
Intervention Description
Lifestyle intervention with presentations by multiple professionals (nutritionists, exercise trainers, and psychotherapists), this intervention will include Mediterranean diet education, physical activity, social support, food tasting and cooking, goal setting,and women's health topics. In addition, there will be training in leadership skills, community interventions, community needs assessment, intervention planning and outcomes assessment.
Intervention Type
Behavioral
Intervention Name(s)
Pilot
Intervention Description
Lifestyle intervention with presentations by multiple professionals (nutritionists, exercise trainers, and psychotherapists), this intervention will include Mediterranean diet education, physical activity, social support, food tasting and cooking, goal setting, and women's health topics. In addition, there will be content targeting resilience training including: positive emotions, cognitive flexibility, life meaning, and active coping strategies.
Primary Outcome Measure Information:
Title
Change in Mediterranean Diet adherence
Description
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
Time Frame
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Title
Change in physical activity engagement
Description
Will be assessed through self report of minutes engaged in vigorous and moderate physical via questionnaires.
Time Frame
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Secondary Outcome Measure Information:
Title
Change in Plasma levels of Hemoglobin A1c (HbA1c)
Description
The participants will be referred to their national health insurance in order to conduct a blood test for plasma levels of Hemoglobin A1c (HbA1c)
Time Frame
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Title
Change in Plasma levels of total cholesterol
Description
The participants will be referred to their national health insurance in order to conduct a blood test for plasma levels of total cholesterol
Time Frame
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Title
Change in Plasma levels of HDL
Description
The participants will be referred to their national health insurance in order to conduct a blood test for plasma levels of HDL
Time Frame
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Title
Change in Plasma levels of LDL
Description
The participants will be referred to their national health insurance in order to conduct a blood test for plasma levels of LDL
Time Frame
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Title
Change in Plasma levels of triglycerides
Description
The participants will be referred to their national health insurance in order to conduct a blood test for plasma levels of triglycerides
Time Frame
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Title
Change in Body Mass Index (BMI)
Description
BMI will be calculated by measuring weight and height for each participant.
Time Frame
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Title
Change in Blood Pressure (BP)
Description
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
Time Frame
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Title
Change in Cardiovascular Disease Knowledge
Description
Will be assessed through self report questionnaire based on the American Heart Association's knowledge survey items
Time Frame
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Title
Stages of Change for targeted health behaviors
Description
Will be assessed through self report questionnaire
Time Frame
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Title
Change in Leadership Self-Efficacy
Description
Will be assessed through self report questionnaire
Time Frame
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Title
Change in Resilience
Description
Resilience will be measured through the validated 10 items Connor-Davidson Resilience Scale (CD-RISC-10)
Time Frame
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Title
Change in Sense of Coherence
Description
Sense of coherence will be measured through the Sense of Coherence 13-item scale
Time Frame
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Title
Change in Self-Rated health
Description
Self reported status of health will be measured using the Self-Rated health questionnaire
Time Frame
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Over age 18 Able to commit to the intervention timetable Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nisreen Agbaria, RN, MSc
Phone
+972 52-966-8796
Email
nigbaria@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Donna Zwas, MD, MPH
Phone
+9722-677-9451
Email
dannaz@hadassah.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna Zwas, MD, MPH
Organizational Affiliation
Hadassah University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beit-Safafa community center
City
Jerusalem
ZIP/Postal Code
95822
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
director of the center
Phone
02690717
Email
beitzafa@matnasim.org.il

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
yes, to investigators with certified GCP upon request
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Community-Based Lifestyle Intervention for Diabetes Prevention in Arab Women

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