Health BehaviorNCT05135598
Partners For Life: Off-line Health Promotion Program for Ultra-orthodox Jewish Women During the COVID-19 Pandemic
A study testing Partners for Life health behavior change program in people with Health Behavior, run by Donna R Zwas at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Partners for Life health behavior change program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2020to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah University Medical Center
Jerusalem
Elisheva Leiter, PhD, 02-6779340, elisheval@hadassah.org.il
About this study
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.
Read the 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.
- Conditions
- Health Behavior
- Being tested
- Partners for Life health behavior change program
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partners for Life health behavior change programOther
A health behavior change intervention based on partner learning, utilizing low-tech media and a workbook.
| Study group | Role | What they receive |
|---|---|---|
| Health behavior change intervention | Experimental | Participants will receive a pedometer, workbook, partner, and 15 weekly phone group meetings. Receives: Other: Partners for Life health behavior change program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At intervention completion after 15 weeks
Secondary outcomes (2)
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.
Measured: At intervention completion after 15 weeks
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.
Measured: At intervention completion after 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start1 Mar 2020
- Primary completionFeb 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post evaluation
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Donna R Zwas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Donna R Zwas, Hadassah Medical Organization
- Investigators
- Donna Zwas, MD, Principal investigator, Hadassah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135598
- Sponsor's protocol ID
- 2020123-HMO-CTIL
- Status last verified
- Apr 2023
- First submitted
- 2 Sep 2021
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26879459Chiuve 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.
PubMed 25398889
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partners For Life: Off-line Health Promotion Program for Ultra-orthodox Jewish Women During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT05135598
- Acronym / sponsor ID
- 2020123-HMO-CTIL
- Conditions
- Health Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Donna R ZwasUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post evaluation
| Arm | Type | Receives |
|---|---|---|
| Health behavior change intervention | Experimental | Other: Partners for Life health behavior change programParticipants will receive a pedometer, workbook, partner, and 15 weekly phone group meetings. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partners for Life health behavior change programA health behavior change intervention based on partner learning, utilizing low-tech media and a workbook. | Other | Health behavior change intervention |
Primary outcome
Healthy Heart Score
Time frame: At intervention completion after 15 weeks
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
Time frame: At intervention completion after 15 weeks
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
Time frame: At intervention completion after 15 weeks
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
Time frame: At intervention completion after 15 weeks
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.
2 secondary outcomes
Emotion Regulation Skills
Time frame: At intervention completion after 15 weeks
Body Mass Index (BMI)
Time frame: At intervention completion after 15 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Background: PubMed 26879459Neamah 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.
- Background: PubMed 25398889Chiuve 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna Zwas, MD principal investigator
Hadassah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partners for Life health behavior change program in people with Health Behavior, run by Donna R Zwas at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisheva Leiter, PhD (02-6779340, elisheval@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy Heart Score (time frame: At intervention completion after 15 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05135598, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.