Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1641 participants
INTERVENTIONAL
2011-05-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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electronic intervention group 2
(e-intervention 2) receives a behavioral intervention through a website during pregnancy and until 18 months postpartum
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
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
electronic intervention during pregnancy
Electronically-mediated behavioral interventions to encourage women to gain an appropriate amount of weight during pregnancy.
Control
Control
Control women will receive non-weight related content during both time periods at the project website.
Interventions
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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
electronic intervention during pregnancy
Electronically-mediated behavioral interventions to encourage women to gain an appropriate amount of weight during pregnancy.
Control
Control women will receive non-weight related content during both time periods at the project website.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
35 Years
FEMALE
Yes
Sponsors
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Cornell University
OTHER
University of Rochester
OTHER
Responsible Party
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Diana Fernandez
Associate Professor of Public Health Sciences
Principal Investigators
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Isabel D Fernandez, MD, MPH, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Christine M Olson, PhD
Role: PRINCIPAL_INVESTIGATOR
Cornell University
Locations
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University of Rochester
Rochester, New York, United States
Countries
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References
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Yu Y, Ma Q, Fernandez ID, Groth SW. Mental Health, Behavior Change Skills, and Eating Behaviors in Postpartum Women. West J Nurs Res. 2022 Oct;44(10):932-945. doi: 10.1177/01939459211021625. Epub 2021 Jun 4.
Olson CM, Groth SW, Graham ML, Reschke JE, Strawderman MS, Fernandez ID. The effectiveness of an online intervention in preventing excessive gestational weight gain: the e-moms roc randomized controlled trial. BMC Pregnancy Childbirth. 2018 May 9;18(1):148. doi: 10.1186/s12884-018-1767-4.
Olson CM, Strawderman MS, Graham ML. Association between consistent weight gain tracking and gestational weight gain: Secondary analysis of a randomized trial. Obesity (Silver Spring). 2017 Jul;25(7):1217-1227. doi: 10.1002/oby.21873. Epub 2017 Jun 2.
Graham ML, Strawderman MS, Demment M, Olson CM. Does Usage of an eHealth Intervention Reduce the Risk of Excessive Gestational Weight Gain? Secondary Analysis From a Randomized Controlled Trial. J Med Internet Res. 2017 Jan 9;19(1):e6. doi: 10.2196/jmir.6644.
Fernandez ID, Groth SW, Reschke JE, Graham ML, Strawderman M, Olson CM. eMoms: Electronically-mediated weight interventions for pregnant and postpartum women. Study design and baseline characteristics. Contemp Clin Trials. 2015 Jul;43:63-74. doi: 10.1016/j.cct.2015.04.013. Epub 2015 May 6.
Demment MM, Graham ML, Olson CM. How an online intervention to prevent excessive gestational weight gain is used and by whom: a randomized controlled process evaluation. J Med Internet Res. 2014 Aug 20;16(8):e194. doi: 10.2196/jmir.3483.
Other Identifiers
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HL096760
Identifier Type: -
Identifier Source: org_study_id