eMOMS of Rochester (eMOMS)
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|ClinicalTrials.gov Identifier: NCT01331564|
Recruitment Status : Completed
First Posted : April 8, 2011
Last Update Posted : December 2, 2015
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|Condition or disease||Intervention/treatment||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 (Clinical Trial)|
|Actual Enrollment :||1641 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Electronically-Mediated Weight Interventions for Pregnant and Postpartum Women|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||December 2014|
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
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.
|Placebo Comparator: Control||
Control women will receive non-weight related content during both time periods at the project website.
Other Name: Control group
- Proportion of women whose gestational gain is within the recommended gestational weight gain Institute of Medicine Guidelines in kilograms [ Time Frame: 40 weeks ]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 ]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.
- Caloric Intake in Kilocalories [ Time Frame: 2 years ]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 ]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
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|Ages Eligible for Study:||18 Years to 35 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01331564
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Isabel D Fernandez, MD, MPH, PhD||University of Rochester|
|Principal Investigator:||Christine M Olson, PhD||Cornell University|
|Responsible Party:||Diana Fernandez, Associate Professor of Public Health Sciences, University of Rochester|
|Other Study ID Numbers:||
|First Posted:||April 8, 2011 Key Record Dates|
|Last Update Posted:||December 2, 2015|
|Last Verified:||November 2015|
Randomized Clinical Trial
Gestational Weight Gain
Body Weight Changes