Clinical trial NCT05135598: 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
Overall status: RECRUITING
Phase: NA
Conditions: Health Behavior
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post evaluation
Primary purpose: OTHER

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.

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

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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.

Primary outcomes:
measure: Healthy Heart Score
timeFrame: At intervention completion after 15 weeks
measure: Eating Behavior
timeFrame: At intervention completion after 15 weeks
measure: Pedometer Steps
timeFrame: At intervention completion after 15 weeks
measure: Energy Expenditure
timeFrame: At intervention completion after 15 weeks
Secondary outcomes:
measure: Emotion Regulation Skills
timeFrame: At intervention completion after 15 weeks
measure: Body Mass Index (BMI)
timeFrame: At intervention completion after 15 weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah University Medical Center
Study officials:
affiliation: Hadassah
name: Donna Zwas, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.