Recruiting

Multi-Level Interventions

Sponsor:

Stanford University

Code:

NCT06724172

Conditions

Obesity and Overweight

Nutrition

Chronic Disease

Diabetes

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Self-Management

Community-Based

Study Details

Brief summary:

The goal of this comparative effectiveness trial is to compare how three different approaches to overcome barriers to resources and provide nutrition and physical activity counseling improve maternal healthy weight in pregnancy and postpartum.

The main question it aims to answer is which of the two multi-level, multi-component interventions has greater effectiveness in reducing maternal postpartum weight retention at 12-months postpartum.

Hypothesis (primary): Both multi-level, multi-component interventions will have greater effectiveness reducing maternal postpartum weight retention at 12-months postpartum than the usual care group.

Hypothesis (secondary): The community-based intervention will have greater effectiveness than the self-management intervention.

Participants will be asked to participate in one of the study interventions from early pregnancy until 12 months postpartum and complete five research visits. General procedures include completion of:

  • Questionnaires
  • Dietary recalls
  • In-depth interviews
  • Anthropometric measurements
  • Collection of blood via finger stick or blood panel

Conditions

Obesity and Overweight

Nutrition

Chronic Disease

Diabetes

Pregnancy

Study ID

NCT06724172

Start date

Jan 22, 2026

Status verified date

Mar, 2026

Completion date

Apr 1, 2030

Anticipated

Primary completion date

Jan 15, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Maternal age 18 years or older
  • Maternal gestational age ≤ 20 weeks with viable singleton pregnancy documented on first trimester ultrasound with an intention to continue pregnancy to term
  • Plans to continue receiving antenatal care at the recruitment site/network
  • Maternal characteristics include at least one of the following:
  • Self identifies as Black/African American
  • Self identifies as Hispanic/Latino/a/e/x
  • Insured by Medicaid
  • Maternal ability to speak English or Spanish
  • Completion of baseline data collection (maternal survey data, weight, and height measurement prior to randomization)

Exclusion Criteria:

  • Age < 18 years at baseline because of unique developmental differences of adolescents and regulations regarding age of consent
  • Underweight (BMI <18 kg/m2) at pre-pregnancy period
  • Underlying disease/treatment that might impact weight status (e.g., significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician)
  • Unwillingness or inability to complete study visits or intervention components
  • Unwillingness or inability to commit to intervention components for self or infant, including plans to move more than 100-mile radius from recruitment site
  • Multiple gestations

Study Design

Enrollment

795 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Self-Management

A self-management intervention through direct provision of social needs supports (grocery, physical activity, and transportation support) with self-directed behavior change tools and usual care.

experimental: Community-Based

A community-based intervention for active social needs referrals assistance with health coaching and active lifestyle intervention and usual care.

no intervention: Usual Care

Patients randomized to the usual care control group will not receive the study interventions. Instead, these patients will receive usual care which includes social needs screening in the clinical setting, targeted community service and program referrals, clinical decision support tools for social needs support in the electronic health record, and routine clinical care with provider-based lifestyle counseling.

Interventions

Self-Management

We will universally offer social needs supports (grocery, physical activity, transportation support) widely in use in clinical settings. Patients may elect to receive all, some, or none of the supports. The patient-directed, structured self-management intervention will be provided through mobile health technology (mHealth) and/or mailings, according to patient preference. Participants will receive health information to support health education and behavior change.

Community-Based

As is currently in use broadly by community health workers, participants will complete a detailed social needs assessment and active assistance with referrals to evidence-based home visiting programs; maternal child health services to promote social support and resource access; and services to improve social determinants of health including active enrollment assistance for WIC, SNAP, healthcare and insurance, legal support, housing, job training, mental health and others. Community health workers will deliver group and individual physical activity support and assistance with behavioral goal setting.

Primary outcome measure

  • Maternal postpartum weight retention at 12-months postpartum. [ Time Frame: From enrollment to the end of the intervention at 12 months postpartum. ]

Central Contacts and Locations

Central contacts

Jennifer Woo Baidal Associate Professor, MD, MPH

650-721-2250jwoo1@stanford.edu

Locations

New York Presbyterian Queens

Recruiting

Flushing, New York, United States, 11355

Contacts

Research Coordinator

718-670-1707rjv9007@nyp.org

Principal Investigator:

Daniel Skupski, MD

Columbia University Medical Center

Recruiting

New York, New York, United States, 10012

Contacts

Maxine Ashby-Thompson, EdD, MPH

212-342-2969ma453@cumc.columbia.edu

Principal Investigator:

Dympna Gallagher, EdD

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Tanisha Green

(646) 501-3868tanisha.green@nyulangone.org

Principal Investigator:

Natasha Williams, EdD, MPH

More Information

Sponsor

Stanford University

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-03-05.