Early Intervention to Promote Cardiovascular Health of Mothers and Children
NCT ID: NCT05856162
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2023-08-01
2024-10-31
Brief Summary
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1. Does a multi-component intervention improve cardiovascular health of pregnant individuals and new mothers enrolled in home visiting programs?
2. Does a multi-component intervention improve cardiovascular health of the offspring of pregnant individuals/new mothers enrolled in home visiting programs?
Participants receiving the multi-component intervention will receive content on promoting cardiovascular health delivered by their home visitor and asynchronously. All participants will be asked to complete assessments at baseline, 2-month follow-up, and 4-month follow-up. The investigators will compare whether pregnant individuals and new mothers randomized to the intervention group, and their offspring, exhibit better cardiovascular health than pregnant individuals and new mothers randomized to the control group.
Detailed Description
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This project is part of the National Heart Lung and Blood Institute (NHLBI) Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) consortium. Northwestern University is one seven clinical centers part of the ENRICH consortium. This project is funded via a UG3/UH3 mechanism in which during the UG3 period each clinical center is responsible for conducting a pilot study to inform the development of a common protocol that will be used across all seven clinical centers during the UH3 phase. This clinicaltrials.gov entry describes the pilot RCT protocol.
The pilot study will use a randomized controlled trial (RCT) longitudinal design. Forty individuals randomized to the intervention arm will receive usual home visiting services along with the ENRICH intervention. Ten individuals randomized to the control arm will receive usual home visiting without the ENRICH intervention. Among the individuals randomized to the intervention condition, 20 (50%) will receive the entire ENRICH intervention while the other 20 will receive only diet and physical activity content. The varying levels of intervention dosage is being delivered to assess acceptability and feasibility of a more- and less-intensive version of the intervention. Components of the intervention are described below. Assessments will be conducted at baseline, 2-month follow-up, and 4-month follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Full Intervention
Participants randomized to this arm will receive the full ENRICH pilot which will consist of content on diet, physical activity, sleep, stress/mental health, and tobacco cessation. They will also receive usual home visiting services.
ENRICH pilot intervention (full intervention)
The full ENRICH pilot intervention will consist of content related to diet, physical activity, stress/mental health, sleep, tobacco cessation, and child health. The investigators will use an adapted version of the Mothers and Babies stress management intervention to address mental health, an adapted version of the HEALTH curriculum to address diet/physical activity, and an adapted version of the INSIGHT curriculum to address child health.
Diet/Physical Activity Intervention
Participants randomized to this arm will receive the partial ENRICH pilot which will consist of content on diet and physical activity. They will also receive usual home visiting services.
ENRICH pilot intervention (partial intervention: only diet and physical activity)
The partial ENRICH intervention will focus only on diet and physical activity.
Control
Participants randomized to this arm will receive no ENRICH intervention content. They will only receive usual home visiting services.
No interventions assigned to this group
Interventions
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ENRICH pilot intervention (full intervention)
The full ENRICH pilot intervention will consist of content related to diet, physical activity, stress/mental health, sleep, tobacco cessation, and child health. The investigators will use an adapted version of the Mothers and Babies stress management intervention to address mental health, an adapted version of the HEALTH curriculum to address diet/physical activity, and an adapted version of the INSIGHT curriculum to address child health.
ENRICH pilot intervention (partial intervention: only diet and physical activity)
The partial ENRICH intervention will focus only on diet and physical activity.
Eligibility Criteria
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Inclusion Criteria
* Pregnant or with child \< 3 months of age
* Enrolled in a Healthy Families America or Parents as Teachers home visiting program in Illinois or or Indiana
Exclusion Criteria
* Individuals who have a fetus with a known chromosomal abnormality
18 Years
39 Years
FEMALE
Yes
Sponsors
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Northwestern University
OTHER
Responsible Party
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Darius Tandon
Associate Professor
Locations
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Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Countries
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Other Identifiers
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STU00216961
Identifier Type: -
Identifier Source: org_study_id