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Development of a Group Prenatal Care Intervention to Address Maternal and Child Non-Communicable Disease (NCD) Risk in American Samoa

NCT04025268 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-04-15

No results posted yet for this study

Summary

To test the efficacy of a group prenatal care intervention to reduce the risk of obesity related health conditions during and after pregnancy in obese mothers and their infants.

Conditions

Interventions

BEHAVIORAL

Group Prenatal Care (GPNC)

GPNC participants will attend 11 group sessions total: 10 during pregnancy and one postpartum. Each session will be 90-100 minutes long. Groups will collectively identify the preferred time of day for these sessions. Groups of 10 women will be led by a locally trained, Samoan nurse-midwife with the study Project Director as a co-facilitator. At each of the visits participants will engage in self-assessments of weight and blood pressure, including learning to take their blood pressure with a digital cuff, calculating BMI, and plotting their weight gain on a graph), receive short individual clinical examinations from a midwife, and participate in group discussions about prenatal care, childbirth preparation, and their postpartum care. The session at 6-weeks postpartum will allow women to introduce their babies to the group and share childbirth stories.

BEHAVIORAL

Standard of Care

Standard of prenatal care

Sponsors & Collaborators

  • Brown University

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Nicola Hawley, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-01
Primary Completion
2019-06-30
Completion
2019-06-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04025268 on ClinicalTrials.gov