Clinical Trials Directory

Trials / Completed

CompletedNCT01331564

eMOMS of Rochester

Electronically-Mediated Weight Interventions for Pregnant and Postpartum Women

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
1,641 (actual)
Sponsor
University of Rochester · Academic / Other
Sex
Female
Age
18 Years – 35 Years
Healthy volunteers
Accepted

Summary

The project aims to develop, implement and evaluate electronically-mediated behavioral intervention programs for pregnant and postpartum women in order to prevent excessive weight gain during pregnancy and postpartum weight retention.

Detailed description

This study seeks to expand the understanding of how to slow the accumulation of weight in childbearing women. The intervention goals are to decrease the prevalence of excessive pregnancy weight gain and mean weight retention in the first 18 months postpartum in socio-economically and racially/ethnically diverse sample of 1,641 pregnant women. Women will be randomly assigned to one of three groups: Intervention Group 1 will receive the intervention program only during pregnancy (e-intervention 1). Intervention Group 2 will receive e-intervention 1 plus intervention for 18 months postpartum (e-intervention 2). Control women will receive non-weight related content during both time periods at the project website. The primary hypotheses for the randomized controlled trial are: H1: The proportion of women in Intervention Groups 1 and 2 who gain more weight in pregnancy than is recommended by the IOM will be 33% less than the proportion of the women in the Control Group who gain excessively and H2: The Control Group will have a higher mean weight retention at 12 months postpartum than Intervention Groups 1 and 2.

Conditions

Interventions

TypeNameDescription
BEHAVIORALelectronic intervention during pregnancy and postpartumElectronically-mediated behavioral interventions to encourage women to gain an appropriate amount of weight during pregnancy and to follow a healthy lifestyle postpartum to minimize postpartum weight retention
BEHAVIORALelectronic intervention during pregnancyElectronically-mediated behavioral interventions to encourage women to gain an appropriate amount of weight during pregnancy.
BEHAVIORALControlControl women will receive non-weight related content during both time periods at the project website.

Timeline

Start date
2011-05-01
Primary completion
2014-05-01
Completion
2014-12-01
First posted
2011-04-08
Last updated
2015-12-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01331564. Inclusion in this directory is not an endorsement.