A Phase 3 interventional study of electronic intervention during pregnancy and postpartum and electronic intervention during pregnancy in Gestational Weight Gain and Postpartum Weight Retention, sponsored by University of Rochester. Completed at 1 site in United States. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-02.
Sponsored by University of Rochester · Phase 3, Interventional, and Prevention
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.
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.
1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.
This study's enrollment of 1,641 is above the median of 64 across 947 interventional studies indexed under Body Weight.
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Exclusion Criteria:
(e-intervention 2) receives a behavioral intervention through a website during pregnancy and until 18 months postpartum
Behavioral: electronic intervention during pregnancy and postpartum
(e-intervention 1) receives a behavioral intervention through a website during pregnancy. During the postpartum period this arm receives the same non-weight-related information as the control arm
Behavioral: electronic intervention during pregnancy
Behavioral: Control
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
Also known as: 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.
Also known as: 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.
Also known as: Control group
Proportion of women whose gestational gain is within the recommended gestational weight gain Institute of Medicine Guidelines in kilograms
Gestational weight gain is the result of the last predelivery weight minus the prepregnancy weight (or early pregnancy weight).
Time frame: 40 weeks
Postpartum weight retention in kg at 12 months postpartum
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: 1.5 years
Caloric Intake in Kilocalories
Caloric intake will be calculated based on the average food intake assessed by 2 24-hour dietary recall.
Time frame: 2 years
Physical activity as an average weekly energy expenditure (METS)
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
Postpartum weight retention at 18 months
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
Time frame: 2 years
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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University of Rochester