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Behavioural Intervention

Community Health Worker (High Touch Group) for Maternal Health

N/A

Recruiting

Led By Natasha Williams, EdD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of study (up to 5 years)

Awards & highlights

Study Summary

This trial will compare two methods of providing lifestyle counseling to pregnant participants. One method involves using technology like text messaging and online videos, while the other method involves in-person counseling led by Community Health Workers.

Who is the study for?

This trial is for pregnant individuals who can participate in lifestyle counseling to improve maternal health. It's not clear what specific conditions exclude someone from participating, but typically, trials require participants to be over a certain age and have the ability to give informed consent.Check my eligibility

What is being tested?

The RESTORE Phase II study is testing two ways of delivering lifestyle advice during pregnancy: one uses text messages and online videos (low touch), while the other involves personal guidance from Community Health Workers (high touch). The study will compare how well each method works and their effects on clinical outcomes.See study design

What are the potential side effects?

Since this trial focuses on non-invasive methods like text messaging and community support rather than medication or medical procedures, significant side effects are not expected. However, there may be indirect impacts related to receiving health information that could affect stress levels or decision-making.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of study (up to 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of study (up to 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study (up to 5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent adoption of the program

Secondary outcome measures

Adequacy of Prenatal Care Utilization Index Score

Level of adherence

Mean gestational weight gain

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Community Health Worker (High Touch Group)Experimental Treatment1 Intervention

During 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.

Group II: Technology supported (Low Touch) StrategyActive Control1 Intervention

During the control period (low touch), asynchronous videos summarizing healthy lifestyle content will be delivered via text messaging.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,841 Previous Clinical Trials

47,813,205 Total Patients Enrolled

NYU Langone HealthLead Sponsor

1,369 Previous Clinical Trials

839,697 Total Patients Enrolled

Natasha Williams, EdDPrincipal InvestigatorNYU Langone Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this study currently available to prospective participants?

"As per the information on clinicaltrials.gov, this research is actively seeking participants. The trial was initially listed on January 26th, 2024 and had its most recent update on April 1st, 2024."

Answered by AI

What is the current capacity for patient enrollment in this clinical trial?

"Yes, the details available on clinicaltrials.gov indicate that this investigation is actively seeking participants. The trial was initially published on January 26th, 2024 and last modified on April 1st, 2024. Recruitment aims to enroll a total of 900 patients across two designated sites."

Answered by AI

Is there an age limit for participants in this clinical study, particularly regarding those above the age of 50?

"Patients within the age range of 18 to 89 are eligible for enrollment in this research. Additionally, there are specific studies available for individuals under 18 years old as well as those over 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

RESTORE - Phase II

2024. "RESTORE - Phase II". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06349070.

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