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CHIME: Comparing Health Interventions for Maternal Equity

Offene Rekrutierung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06724172 (CHIME) ist eine interventionsstudie zur Untersuchung von Obesity and Overweight, Ernährung, Chronische Krankheit, Diabetes, Schwangerschaft und hat den Status offene rekrutierung. Die Studie startete am 1. April 2026 und soll 795 Teilnehmer aufnehmen. Durchgeführt von Stanford-Universität ist der Abschluss für 1. April 2030 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 26. November 2025 aktualisiert.
Kurzbeschreibung

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
Offizieller Titel

CHIME: Comparing Health Interventions for Maternal Equity

Erkrankungen
Obesity and OverweightErnährungChronische KrankheitDiabetesSchwangerschaft
Weitere Studien-IDs
  • CHIME
  • 77034
  • 20244792 (Andere Zuwendungs-/Finanzierungsnummer) (Patient-Centered Outcomes Research Institute (PCORI))
NCT-Nummer
NCT06724172
Studienbeginn (tatsächlich)
2026-04-01
Zuletzt aktualisiert
2025-11-26
Studienende (vorauss.)
2030-04-01
Geplante Rekrutierung
795
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Doppelt verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellSelf-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.
Selbstmanagement
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.
ExperimentellCommunity-Based
A community-based intervention for active social needs referrals assistance with health coaching and active lifestyle intervention and usual care.
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.
Keine InterventionUsual 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.
Nicht zutreffend
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Maternal postpartum weight retention at 12-months postpartum.
The primary outcome will be calculated as the difference between baseline weight and 12-month postpartum weight. Baseline weight will be defined as the first clinical measure of maternal weight prior to 12 weeks gestation.
From enrollment to the end of the intervention at 12 months postpartum.
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Household social needs and maternal perinatal health outcomes
We will obtain patient self-reported measures where applicable for secondary outcomes through validated questionnaires. Secondary outcomes include household food security, gestational weight gain, gestational diabetes, with maternal race and ethnicity and pre-pregnancy body mass index category as effect modifiers.
From enrollment to the end of the intervention at 12 months postpartum.
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Weiblich
Akzeptiert gesunde Freiwillige
Ja
  • 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)

  • 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
Stanford University logoStanford-Universität671 aktive klinische Studien zum Erkunden
Patient-Centered Outcomes Research Institute logoPatient-Centered Outcomes Research Institute
Verantwortliche Partei
Jennifer Woo Baidal, Hauptprüfer, Associate Professor, Stanford University
Zentrale Studienkontakte
Kontakt: Jennifer Woo Baidal Associate Professor, MD, MPH, 650-721-2250, [email protected]
2 Studienstandorte in 1 Ländern

California

Stanford University, Palo Alto, California, 94304, United States
Aktiv, nicht rekrutierend

New York

New York Presbyterian Queens, Flushing, New York, 11355, United States
Research Coordinator, Kontakt, 718-670-1707, [email protected]
Daniel Skupski, MD, Hauptprüfer
Offene Rekrutierung