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Maternal HealthNCT06349070

RESTORE - Phase II

A study testing Low Touch - Text Messaging Implementation Strategy and High Touch - Community Health Worker (CHW) Implementation Strategy in people with Maternal Health, run by NYU Langone Health at 2 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The study will apply the principles of Community Based Participatory Research to evaluate implementation strategies, designed to assist in the delivery of an evidence-based lifestyle counseling intervention for pregnant participants. Read more about this study

Who is it for?
Ages 18 to 89 years, women onlyHealthy volunteers can take part
Conditions the study is for
Maternal Health
What is being tested?
Low Touch - Text Messaging Implementation Strategy and High Touch - Community Health Worker (CHW) Implementation Strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,050 participants
Where
2 sitesUnited States
Study dates
26 Jan 2024to 30 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 89 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Enrolled as a subject in the Implementation Group (Low Touch or High Touch) within the first trimester (before the end of the 13th week (13w6d))
  • willing and able to provide consent for baseline and follow up surveys

Who cannot join

  • Significant psychiatric or developmental disability as noted in the medical record.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites

  • NYC Health + Hospitals/Bellevue

    New York, New York, 10016

  • NYU Langone Health

    New York, New York, 10016

Other trials in United States

About this study

Official title: Bridging Maternal Lifestyle Education, and Counseling With Community Health Workers and Health Equity - Phase II

The study will apply the principles of Community Based Participatory Research to evaluate implementation strategies, designed to assist in the delivery of an evidence-based lifestyle counseling intervention for pregnant participants. The primary strategies include a technology supported strategy (low touch) in which text messaging and online videos are used for asynchronous viewing compared to a Community Health Worker-led synchronous (group and individual) strategy (high touch). Prior to implementation, one-time interview and focus groups will be conducted with clinic providers and staff. In addition, a subsample of subjects will be enrolled into a prospective cohort to complete a survey during pregnancy and a survey postpartum. The aims of the study are 1) to evaluate and compare adoption of the program delivery with text technology messaging vs. delivery by Community Health Workers (CHW), 2) to examine implementation fidelity , 3) to evaluate and compare the impact of the strategies on key clinical outcomes, 4) to examine sustainability (continued adoption) following the CHW-led strategy implementation period and conduct an economic evaluation of the two-implementation strategies.

Conditions
Maternal Health
Being tested
Low Touch - Text Messaging Implementation Strategy, High Touch - Community Health Worker (CHW) Implementation Strategy
Keywords
Pregnancy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low Touch - Text Messaging Implementation StrategyBehavioural

    The low touch strategy is designed as a tool to distill and organize the most important information from the Starting Early Program (StEP) original evidenced-based intervention curriculum. Video links are sent to pregnant subjects via automated SMS messaging. Subjects will receive videos (20 videos total) at least weekly lasting 17 to 31 weeks and the duration is based upon the gestational age at enrollment into the study. Subjects will also receive SMS messages in between videos at least weekly to keep them engaged and reinforce the video content delivered. The StEP curriculum is guideline concordant and includes sessions delivered during pregnancy coordinated with prenatal visits. The sessions delivered during pregnancy aim to improve diet, physical activity and stress management, enhance prenatal breastfeeding support, and build social support. The StEP curriculum was adapted into brief videos (<5 minutes), and an additional module on Sleep Health was added.

  • High Touch - Community Health Worker (CHW) Implementation StrategyBehavioural

    The curriculum will be delivered by CHWs. Each subject will be asked to participate in 1-hour live sessions with a CHW. During the sessions, videos are interspersed with open-ended questions and pauses to discuss these open-ended questions. This results in an interactive session that employs principles of active learning. The curriculum includes sessions delivered during pregnancy coordinated with prenatal visits. The sessions delivered during pregnancy aim to improve diet, physical activity and stress management during pregnancy, enhance prenatal breastfeeding support, and build social support and are anchored by the same brief videos developed for the low touch strategy.

Study groups in NCT06349070
Study groupRoleWhat they receive
Technology supported (Low Touch) StrategyActive comparatorDuring the control period (low touch), asynchronous videos summarizing healthy lifestyle content will be delivered via text messaging.
Receives: Behavioral: Low Touch - Text Messaging Implementation Strategy
Community Health Worker (High Touch Group)ExperimentalDuring the intervention period (high touch) asynchronous and synchronous learning whereby content will be delivered by trained M-CHWs who are equipped to directly address social determinants of health-related needs and barriers to prenatal care.
Receives: Behavioral: High Touch - Community Health Worker (CHW) Implementation Strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent adoption of the program

    Adoption of the program will be measured as the number of patients correctly referred and enrolled offset by the number of eligible pregnant subjects screened

    Measured: End of study (up to 5 years)

Secondary outcomes (10)

  1. Mean number of videos viewed

    Measured: Month 12

  2. Mean number of sessions completed

    Measured: Month 12

  3. Level of adherence

    Adherence to the program will measure the extent to which the program was implemented per the protocol. This will assess whether components of the program (i.e. identify, counsel, treat, refer and the 5A's) were implemented as intended using data from checklists completed by the training facilitators. Each component will be rated on a 3-point scale: 1=The component was fully implemented and/or modified with permission, as per protocol; 2=The component was partially implemented; and 3=The component was not implemented, as per protocol.

    Measured: Month 12

  4. Adequacy of Prenatal Care Utilization Index Score

    This outcome measure will be collected from electronic health record. Adequacy is measured using the Adequacy of Prenatal Care Utilization Index, which classifies prenatal care received into 1 of 4 categories (Inadequate (received less than 50% of expected visits), Intermediate (50%-79%), Adequate (80%-109%), Adequate Plus (110% or more)) by combining information about the timing of prenatal care, the number of visits, and the infant's gestational age.

    Measured: Month 12

  5. Number of postpartum follow-up visits attended

    This outcome measure will be collected from the electronic health record.

    Measured: 12 weeks postpartum

  6. Number of subjects who had a pre-term delivery

    This outcome measure will be collected from the electronic health record.

    Measured: 12 weeks postpartum

  7. Number of subjects with post-partum depression

    This outcome measure will be collected from the electronic health record.

    Measured: 12 weeks postpartum

  8. Mean gestational weight gain

    This outcome measure will be collected from the electronic health record.

    Measured: 12 weeks postpartum

  9. Percent sustainability (continued adoption) following the M-CHW implementation period

    Sustainability is measured as the number of those correctly referred and enrolled offset by the denominator of subjects screened.

    Measured: End of study (up to 5 years)

  10. Program Costs

    Costs of each implementation stage will be calculated by calculating comparative resources associated with implementation

    Measured: End of study (up to 5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2024
  2. Study start26 Jan 2024
  3. Primary completion30 Jan 2027 (estimated)
  4. Study completion30 Mar 2027 (estimated)

Resources

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
Sequential
Model description
The study is a hybrid type III implementation-effectiveness trial using a longitudinal cluster-randomized trial with a modified stepped wedge design. In Year 1, all 10 clinics start with the low touch strategy, followed by randomization of clinics in Year 2 to either low touch (5 clinics) or high touch (5 clinics), and finally in Year 3, all 10 clinics will transition to the high touch strategy. Starting in Year 2, we will enroll a subsample of subjects into the a prospective cohort of pregnant persons who will participate in surveys at baseline and postpartum.
Masking
None (open label)
Enrolment
1,050 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06349070
Sponsor's protocol ID
23-00404
Status last verified
Sep 2026
First submitted
1 Apr 2024
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: erinn.hade@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research

Questions about this trial

What is this clinical trial studying?

A study testing Low Touch - Text Messaging Implementation Strategy and High Touch - Community Health Worker (CHW) Implementation Strategy in people with Maternal Health, run by NYU Langone Health at 2 sites 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 2 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

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?

Percent adoption of the program (time frame: End of study (up to 5 years)). 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 NCT06349070.

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 17 Sep 2026.

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