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

NCT05135598 | Unknown

• 1 other identifier: 2020123-HMO-CTIL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Behavior

Outcome Measures

Primary Outcomes (4)

• 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.

  At intervention completion after 15 weeks

• 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.

  At intervention completion after 15 weeks

• 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.

  At intervention completion after 15 weeks

• 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.

  At intervention completion after 15 weeks

Secondary Outcomes (2)

• Emotion Regulation Skills

  At intervention completion after 15 weeks

• Body Mass Index (BMI)

  At intervention completion after 15 weeks

Study Arms (1)

Health behavior change intervention

EXPERIMENTAL

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

Other: Partners for Life health behavior change program

Interventions

Partners for Life health behavior change program OTHER

A health behavior change intervention based on partner learning, utilizing low-tech media and a workbook.

Health behavior change intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Individuals who self-represent as female will be eligible.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Donna R Zwas: lead

Study Sites (1)

Hadassah University Medical Center

Jerusalem, Israel

RECRUITING

Related Publications (2)

• 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.

  PMID: 26879459 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

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Donna Zwas, MD

  Hadassah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisheva Leiter, PhD

CONTACT

02-6779340; elisheval@hadassah.org.il

Lori Sloman, BS

CONTACT

02-6779451; lori@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Pre-post evaluation

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: November 26, 2021
• Study Start: March 1, 2020
• Primary Completion: February 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)