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Partners For Life: Off-line Health Promotion Program for Ultra-orthodox Jewish Women During the COVID-19 Pandemic

Primary Purpose

Health Behavior

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Partners for Life health behavior change program
Sponsored by
Donna R Zwas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Health Behavior

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Females aged 18-85, willingness to commit to participation in the lifestyle intervention and follow-up.

-

Exclusion Criteria: Pregnancy, history of schizophrenia, severe depression, untreated bipolar disorder, end-stage renal disease, type 1 diabetes, unstable angina, congestive heart failure, inability to participate in the group without assistance, dementia, inability to communicate in Hebrew.

Sites / Locations

  • Hadassah University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Health behavior change intervention

Arm Description

Participants will receive a pedometer, workbook, partner, and 15 weekly phone group meetings.

Outcomes

Primary Outcome Measures

Healthy Heart Score
The Healthy Heart Score is a lifestyle-based CVD prediction model that was developed using health data from 61,025 women in the Nurses' Health Study and 34,478 men in the Health Professionals Follow-up Study, who were free of chronic disease in 1986 and followed for CVD for up to 24 years. The Healthy Heart Score is based on the diet and lifestyle factors that include smoking, weight, exercise, and intake of alcohol, fruits and vegetables, whole grains, nuts, sugary beverages, and red and processed meat. On a prospective study, women with higher predicted CVD risk based on the Healthy Heart Score had an 18-fold higher risk of type 2 diabetes mellitus,5-fold higher risk of hypertension, and 3-fold higher risk of hypercholesterolemia during 20 years.
Eating Behavior
The Dutch Eating Behavior Questionnaire (DEBQ) is a measure of Restrained, External, and Emotional eating. This questionnaire has good internal consistency and factorial validity as well as predictive validity for food consumption.
Pedometer Steps
Pedometer steps (measured with the Omron pedometer Model HJ-320) will provide an objective measure of increased physical activity. Omron pedometers have been shown to demonstrate validity and reliability at various mounting positions in both healthy and overweight adults. Participants in all groups will be reminded to wear the pedometer for the week before each data collection point to assess average weekly step count. Intervention participants will also provide weekly step count data throughout the intervention. Measures will include average daily steps, as an objective measure of physical activity, and percentage change in steps, as an objective measure of change in physical activity level.
Energy Expenditure
The Ministry of Health (as well as the World Health Organization) recommends engaging in at least 150 minutes of moderate physical activity or 75 minutes of vigorous physical activity per week. Exercising at the level of 500 MET-minutes per week has been defined as the threshold for an average reduction of 20% to 30% in mortality risk and exercise may have comparatively increased benefits in women compared to men. Energy expenditure will be assessed by the self-administered Women's Health Initiative Physical Activity Questions (WHI-PAQ), measuring recreational physical activities. The Women's Health Initiative was a pivotal, prospective study of women's health, including the impact of health behavior on cardiovascular health54. The WHI PAQ has been validated compared to accelerometry and has been shown to be reliable. Metabolic equivalents (METs) will be calculated based on energy expenditure related to these activities using standardized classifications.

Secondary Outcome Measures

Emotion Regulation Skills
The Difficulties in Emotion Regulation Scale-16 (DERS-16) is a brief measure of emotion regulation difficulties. This scale demonstrates good internal consistency, test-retest reliability, as well as convergent and discriminant validity.
Body Mass Index (BMI)
Weight will be measured in kilograms using a standardized, calibrated scale and height will be measured using a standardized stadiometer. Weight loss in kilograms and percent weight loss will be calculated. BMI will be calculated by body weight /height2, and change in BMI will be calculated.

Full Information

First Posted
September 2, 2021
Last Updated
April 23, 2023
Sponsor
Donna R Zwas
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1. Study Identification

Unique Protocol Identification Number
NCT05135598
Brief Title
Partners For Life: Off-line Health Promotion Program for Ultra-orthodox Jewish Women During the COVID-19 Pandemic
Official Title
Partners For Life: Off-line Health Promotion Program for Ultra-orthodox Jewish Women During the COVID-19 Pandemic
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Donna R Zwas

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
The purpose of this study is to evaluate a unique culturally-tailored intervention aimed at increasing healthy eating and physical activity in Ultra-Orthodox Jewish women during the COVID-19 pandemic. Utilizing a pre-post study design, this intervention is based on the CDC's Diabetes Prevention Program (DPP) and integrates low-tech media, partner learning, group support, and practical workbook content.
Detailed Description
UOJ women in Israel have poorer health outcomes and sub-optimal health behaviors than their counterparts. Contributing factors to these disparities include poverty, limited access to information, and insufficient culturally-appropriate opportunities. COVID-19 has exacerbated this inequity, with reduced income, opportunities and time availability, as well as increased weight, social isolation, loss, stress and emotional issues. While COVID-19 brought these health issues to the forefront, they are ongoing - and currently overlooked. The purpose of this study is to evaluate a unique culturally-tailored intervention aimed at increasing healthy eating and physical activity in Ultra-Orthodox Jewish women during the COVID-19 pandemic. Utilizing a pre-post study design, this intervention is based on the CDC's Diabetes Prevention Program (DPP) and integrates low-tech media, partner learning, group support, and practical workbook content. Participants are recruited through an Ultra-orthodox Jewish continuing education institution for women and either register with a friend or are assigned a partner. Each woman receives a pedometer and workbook with information and skill-building worksheets to complete weekly in pairs (via phone or in person). All dyads will join weekly phone-based group meetings led by a group leader, to share challenges and successes as well as problem solve. It is hypothesized that this intervention will increase the targeted health behaviors as well as reduce weight in participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Behavior

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-post evaluation
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Health behavior change intervention
Arm Type
Experimental
Arm Description
Participants will receive a pedometer, workbook, partner, and 15 weekly phone group meetings.
Intervention Type
Other
Intervention Name(s)
Partners for Life health behavior change program
Intervention Description
A health behavior change intervention based on partner learning, utilizing low-tech media and a workbook.
Primary Outcome Measure Information:
Title
Healthy Heart Score
Description
The Healthy Heart Score is a lifestyle-based CVD prediction model that was developed using health data from 61,025 women in the Nurses' Health Study and 34,478 men in the Health Professionals Follow-up Study, who were free of chronic disease in 1986 and followed for CVD for up to 24 years. The Healthy Heart Score is based on the diet and lifestyle factors that include smoking, weight, exercise, and intake of alcohol, fruits and vegetables, whole grains, nuts, sugary beverages, and red and processed meat. On a prospective study, women with higher predicted CVD risk based on the Healthy Heart Score had an 18-fold higher risk of type 2 diabetes mellitus,5-fold higher risk of hypertension, and 3-fold higher risk of hypercholesterolemia during 20 years.
Time Frame
At intervention completion after 15 weeks
Title
Eating Behavior
Description
The Dutch Eating Behavior Questionnaire (DEBQ) is a measure of Restrained, External, and Emotional eating. This questionnaire has good internal consistency and factorial validity as well as predictive validity for food consumption.
Time Frame
At intervention completion after 15 weeks
Title
Pedometer Steps
Description
Pedometer steps (measured with the Omron pedometer Model HJ-320) will provide an objective measure of increased physical activity. Omron pedometers have been shown to demonstrate validity and reliability at various mounting positions in both healthy and overweight adults. Participants in all groups will be reminded to wear the pedometer for the week before each data collection point to assess average weekly step count. Intervention participants will also provide weekly step count data throughout the intervention. Measures will include average daily steps, as an objective measure of physical activity, and percentage change in steps, as an objective measure of change in physical activity level.
Time Frame
At intervention completion after 15 weeks
Title
Energy Expenditure
Description
The Ministry of Health (as well as the World Health Organization) recommends engaging in at least 150 minutes of moderate physical activity or 75 minutes of vigorous physical activity per week. Exercising at the level of 500 MET-minutes per week has been defined as the threshold for an average reduction of 20% to 30% in mortality risk and exercise may have comparatively increased benefits in women compared to men. Energy expenditure will be assessed by the self-administered Women's Health Initiative Physical Activity Questions (WHI-PAQ), measuring recreational physical activities. The Women's Health Initiative was a pivotal, prospective study of women's health, including the impact of health behavior on cardiovascular health54. The WHI PAQ has been validated compared to accelerometry and has been shown to be reliable. Metabolic equivalents (METs) will be calculated based on energy expenditure related to these activities using standardized classifications.
Time Frame
At intervention completion after 15 weeks
Secondary Outcome Measure Information:
Title
Emotion Regulation Skills
Description
The Difficulties in Emotion Regulation Scale-16 (DERS-16) is a brief measure of emotion regulation difficulties. This scale demonstrates good internal consistency, test-retest reliability, as well as convergent and discriminant validity.
Time Frame
At intervention completion after 15 weeks
Title
Body Mass Index (BMI)
Description
Weight will be measured in kilograms using a standardized, calibrated scale and height will be measured using a standardized stadiometer. Weight loss in kilograms and percent weight loss will be calculated. BMI will be calculated by body weight /height2, and change in BMI will be calculated.
Time Frame
At intervention completion after 15 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Individuals who self-represent as female will be eligible.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Females aged 18-85, willingness to commit to participation in the lifestyle intervention and follow-up. - Exclusion Criteria: Pregnancy, history of schizophrenia, severe depression, untreated bipolar disorder, end-stage renal disease, type 1 diabetes, unstable angina, congestive heart failure, inability to participate in the group without assistance, dementia, inability to communicate in Hebrew.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisheva Leiter, PhD
Phone
02-6779340
Email
elisheval@hadassah.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Lori Sloman, BS
Phone
02-6779451
Email
lori@hadassah.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna Zwas, MD
Organizational Affiliation
Hadassah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah University Medical Center
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisheva Leiter, PhD
Phone
02-6779340
Email
elisheval@hadassah.org.il

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26879459
Citation
Neamah HH, Sebert Kuhlmann AK, Tabak RG. Effectiveness of Program Modification Strategies of the Diabetes Prevention Program: A Systematic Review. Diabetes Educ. 2016 Apr;42(2):153-65. doi: 10.1177/0145721716630386. Epub 2016 Feb 15.
Results Reference
background
PubMed Identifier
25398889
Citation
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.
Results Reference
background

Learn more about this trial

Partners For Life: Off-line Health Promotion Program for Ultra-orthodox Jewish Women During the COVID-19 Pandemic

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