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eMOMS of Rochester

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Cornell University
Information provided by (Responsible Party):
Diana Fernandez, University of Rochester
ClinicalTrials.gov Identifier:
NCT01331564
First received: March 31, 2011
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Gestational Weight Gain
Postpartum Weight Retention
Behavioral: electronic intervention during pregnancy and postpartum
Behavioral: electronic intervention during pregnancy
Behavioral: Control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Electronically-Mediated Weight Interventions for Pregnant and Postpartum Women

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Proportion of women whose gestational gain is within the recommended gestational weight gain Institute of Medicine Guidelines in kilograms [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    Gestational weight gain is the result of the last predelivery weight minus the prepregnancy weight (or early pregnancy weight).

  • Postpartum weight retention in kg at 12 months postpartum [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Caloric Intake in Kilocalories [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Caloric intake will be calculated based on the average food intake assessed by 2 24-hour dietary recall.

  • Physical activity as an average weekly energy expenditure (METS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Physical activity during pregnancy is measured using the Pregnancy Physical Activity Questionnaire and during postpartum using the Global Physical Activity Questionnaire.

  • Postpartum weight retention at 18 months [ 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


Estimated Enrollment: 1641
Study Start Date: May 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: electronic intervention group 2
(e-intervention 2) receives a behavioral intervention through a website during pregnancy and until 18 months postpartum
Behavioral: electronic intervention during pregnancy and postpartum
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
Experimental: electronic intervention group 1
(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
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
Placebo Comparator: Control Behavioral: Control
Control women will receive non-weight related content during both time periods at the project website.
Other Name: Control group

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 - 35 at the time of delivery
  • Consented at or before 20 weeks gestation
  • Intending to be available for a 24 months intervention
  • Plan to deliver in one of the 4 hospitals in Rochester, NY (the study area)
  • Plan to carry the pregnancy to term
  • Plan to keep the baby
  • Read and understand English

Exclusion Criteria:

  • BMI < 18.5 kg/m2 and > 35.0 kg/m2.
  • Multiple gestation. If multiple gestation is diagnosed after enrollment participant will be terminated from the study (reasons for termination will be included in the consent form)
  • Medical conditions prior to pregnancy which could influence weight loss or gain: cystic fibrosis, hyperthyroidism, renal insufficiency1, proteinuria1, cerebral palsy, lupus erythematosus; rheumatoid arthritis, Crohns disease (severity and other autoimmune diseases evaluated case by case), ulcerative colitis, maternal congenital heart disease (patients are often underweight); hypertension treated with medication2,
  • Psychiatric medication associated with major weight gain or loss (e.g.; Lithium & Divalproex) Common Criteria
  • Household member on study staff
  • Past or planned (within the next 24 months) weight loss surgery (e.g. gastric bypass, lap band, or liposuction); current participation in a commercial weight loss program (e.g. Weight Watcher's, Jenny Craig); currently enrolled or planned to enroll in a weight loss or another weight gain prevention study
  • Participants will be excluded during screening if they report regular use of systemic steroids, prescription weight loss drugs, and/or diabetes medications (oral or injected- insulin, metformin, byetta, TZDs, other). "Regular use" is defined as "taking this medication most days of the week for the previous month"
  • Current treatment for eating disorder
  • Positive screening for bulimia
  • Weight loss of more than 15 pounds in the three months prior to pregnancy
  • Cardiovascular event (heart attack, stroke, episode of heart failure, or revascularization procedure) within the last 6 month. Revascularization is defined as bypass surgery or stints
  • Mental or psychiatric condition that precludes giving informed consent and completing questionnaires
  • Current treatment for malignancy (other than non-melanoma skin cancer and CIN cervix) or on remission for less than 5 years
  • Blood pressure criterion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331564

Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Cornell University
Investigators
Principal Investigator: Isabel D Fernandez, MD, MPH, PhD University of Rochester
Principal Investigator: Christine M Olson, PhD Cornell University
  More Information

No publications provided by University of Rochester

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Diana Fernandez, Associate Professor of Public Health Sciences, University of Rochester
ClinicalTrials.gov Identifier: NCT01331564     History of Changes
Other Study ID Numbers: HL096760
Study First Received: March 31, 2011
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Pregnancy
Postpartum
Weight gain
Weight retention
Behavior
Electronic Media
Randomized Clinical Trial

Additional relevant MeSH terms:
Body Weight
Weight Gain
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014