University of Rochester
Rochester, New York, 14642, United States
NCT Number: NCT01331564
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.
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Notify Me18 year–35 year
Female
Interventional
Phase 3
Rochester, New York, 14642, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Electronically-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
Other names: Behavior modification intervention for pregnancy, Behavior modification intervention for postpartum, Prevention of excessive gestational weight gain, Prevention of postpartum weight retention, Electronically-mediated behavioral interventions
Electronically-mediated behavioral interventions to encourage women to gain an appropriate amount of weight during pregnancy.
Other names: Behavior modification intervention for pregnancy, Prevention of excessive gestational weight gain, Electronically-mediated behavioral interventions
Control women will receive non-weight related content during both time periods at the project website.
Other names: Control group
Time frame: 40 weeks
Gestational weight gain is the result of the last predelivery weight minus the prepregnancy weight (or early pregnancy weight).
Time frame: 1.5 years
The difference between the weight at 12 months postpartum and the pre-pregnancy weight (or early pregnancy weight. Participants will be followed for a maximum of 2 years from recruitment in early pregnancy to 18 months postpartum. The final outcome in the postpartum period is postpartum weight retention at 18 months. Interim measure of postpartum weight will be collected at 6 and 12 months for analyses. The primary hypothesis for the postpartum period is weight retention at 12 months postpartum.
Time frame: 2 years
Caloric intake will be calculated based on the average food intake assessed by 2 24-hour dietary recall.
Time frame: 2 years
Physical activity during pregnancy is measured using the Pregnancy Physical Activity Questionnaire and during postpartum using the Global Physical Activity Questionnaire.
Time frame: 2 years
The difference between the weight at 18 months postpartum and the prepregnancy weight (or early pregnancy weight). Participants will be followed for a maximum of 2 years from recruitment in early pregnancy to 18 months postpartum. The final outcome in the postpartum period is postpartum weight retention at 18 months. Interim measure of postpartum weight will be collected at 6 and 12 months for analyses. The primary hypothesis for the postpartum period is weight retention at 12 months postpartum
University of Rochester
Other
Electronically-Mediated Weight Interventions for Pregnant and Postpartum Women
Acronym: eMOMS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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