Cardiovascular DiseasesENRICHNCT05856162
Early Intervention to Promote Cardiovascular Health of Mothers and Children
A study testing ENRICH pilot intervention (full intervention) and ENRICH pilot intervention (partial intervention: only diet and physical activity) in people with Cardiovascular Diseases, run by Northwestern University at 1 site in United States.
Trial summary
The goal of this clinical trial is to examine whether a multi-component intervention delivered during pregnancy and after delivery can improve the cardiovascular health of pregnant individuals enrolled in home visiting programs, as well as their offspring's cardiovascular health. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- ENRICH pilot intervention (full intervention) and ENRICH pilot intervention (partial intervention: only diet and physical activity)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 31 Oct 2024
- 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 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-39 years old
- 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
Who cannot join
- Individuals pregnant with twins (or higher order gestation)
- Individuals who have a fetus with a known chromosomal abnormality
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: Early Intervention to Promote Cardiovascular Health of Mothers and Children at Northwestern University
The goal of this clinical trial is to examine whether a multi-component intervention delivered during pregnancy and after delivery can improve the cardiovascular health of pregnant individuals enrolled in home visiting programs, as well as their offspring's cardiovascular health. The main questions it aims to answer are:
- Does a multi-component intervention improve cardiovascular health of pregnant individuals and new mothers enrolled in home visiting programs?
- 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.
Read the detailed description
Poor cardiovascular health (CVH) is highly prevalent among pregnant individuals and is associated with adverse maternal and offspring outcomes. As CVH is already suboptimal by early adolescence, early-life interventions are needed. Interventions conducted in the community by trusted programs have the potential to improve CVH risk factors among perinatal individuals and their children. Home Visiting (HV) programs are trusted maternal and child health providers in diverse US communities, especially among low-income families.
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
- Cardiovascular Diseases
- Being tested
- ENRICH pilot intervention (full intervention), ENRICH pilot intervention (partial intervention: only diet and physical activity)
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENRICH pilot intervention (full intervention)Behavioural
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)Behavioural
The partial ENRICH intervention will focus only on diet and physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Full Intervention | Experimental | 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. Receives: Behavioral: ENRICH pilot intervention (full intervention) |
| Diet/Physical Activity Intervention | Active comparator | 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. Receives: Behavioral: ENRICH pilot intervention (partial intervention: only diet and physical activity) |
| Control | No intervention | Participants randomized to this arm will receive no ENRICH intervention content. They will only receive usual home visiting services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diet assessed via the Mediterranean Eating Pattern for Americans Questionnaire
Use of Mediterranean/DASH diet. The MEPA range is from 0-16 with higher scores indicating greater use of a Mediterranean diet
Measured: Change in eating patterns between baseline, 2 month follow-up, and 4 month follow-up
Change in maternal physical activity assessed via the International Physical Activity Questionnaire (IPAQ)
Engagement in physical activity. The IPAQ contains 12 questions with responses scored to create low, moderate, and high physical activity categories
Measured: Change in physical activity between baseline, 2 month follow-up, and 4 month follow-up
Secondary outcomes (1)
Change in maternal depression symptoms assessed via the Edinburgh Postnatal Depression Scale (EPDS)
Depressive symptoms. The EPDS is a 10-item scale with a range of 0-30. Higher scores reflect more depressive symptomatology
Measured: Change in maternal depression between baseline, 2 month follow-up, and 4 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 Aug 2023
- Primary completion31 May 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darius Tandon, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856162
- Sponsor's protocol ID
- STU00216961
- Acronym
- ENRICH
- Status last verified
- Dec 2024
- First submitted
- 4 Apr 2023
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention to Promote Cardiovascular Health of Mothers and Children at Northwestern University
- ClinicalTrials.gov ID
- NCT05856162
- Acronym / sponsor ID
- ENRICH / STU00216961
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 12 May 2023 (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 goal of this clinical trial is to examine whether a multi-component intervention delivered during pregnancy and after delivery can improve the cardiovascular health of pregnant individuals enrolled in home visiting programs, as well as their offspring's cardiovascular health. The main questions it aims to answer are:
- Does a multi-component intervention improve cardiovascular health of pregnant individuals and new mothers enrolled in home visiting programs?
- 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
Poor cardiovascular health (CVH) is highly prevalent among pregnant individuals and is associated with adverse maternal and offspring outcomes. As CVH is already suboptimal by early adolescence, early-life interventions are needed. Interventions conducted in the community by trusted programs have the potential to improve CVH risk factors among perinatal individuals and their children. Home Visiting (HV) programs are trusted maternal and child health providers in diverse US communities, especially among low-income families.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full Intervention | Experimental | Behavioral: ENRICH pilot intervention (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. |
| Diet/Physical Activity Intervention | Active comparator | Behavioral: ENRICH pilot intervention (partial intervention: only diet and physical activity)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. |
| Control | No intervention | –Participants randomized to this arm will receive no ENRICH intervention content. They will only receive usual home visiting services. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-39 years old
- 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
Key exclusion criteria (2 listed)
- Individuals pregnant with twins (or higher order gestation)
- Individuals who have a fetus with a known chromosomal abnormality
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 |
|---|---|---|
| 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. | Behavioural | Full Intervention |
| ENRICH pilot intervention (partial intervention: only diet and physical activity)The partial ENRICH intervention will focus only on diet and physical activity. | Behavioural | Diet/Physical Activity Intervention |
Primary outcome
Change in diet assessed via the Mediterranean Eating Pattern for Americans Questionnaire
Time frame: Change in eating patterns between baseline, 2 month follow-up, and 4 month follow-up
Use of Mediterranean/DASH diet. The MEPA range is from 0-16 with higher scores indicating greater use of a Mediterranean diet
Change in maternal physical activity assessed via the International Physical Activity Questionnaire (IPAQ)
Time frame: Change in physical activity between baseline, 2 month follow-up, and 4 month follow-up
Engagement in physical activity. The IPAQ contains 12 questions with responses scored to create low, moderate, and high physical activity categories
1 secondary outcome
Change in maternal depression symptoms assessed via the Edinburgh Postnatal Depression Scale (EPDS)
Time frame: Change in maternal depression between baseline, 2 month follow-up, and 4 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENRICH pilot intervention (full intervention) and ENRICH pilot intervention (partial intervention: only diet and physical activity) in people with Cardiovascular Diseases, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. 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: finished, as of the sponsor's last update on 13 Dec 2024. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in diet assessed via the Mediterranean Eating Pattern for Americans Questionnaire (time frame: Change in eating patterns between baseline, 2 month follow-up, and 4 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2024.