Clinical trial NCT01331564: eMOMS of Rochester
Official title: Electronically-Mediated Weight Interventions for Pregnant and Postpartum Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gestational Weight Gain
Postpartum Weight Retention
Keywords: Pregnancy
Postpartum
Weight gain
Weight retention
Behavior
Electronic Media
Randomized Clinical Trial
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Cornell University
First posted: 2011-04-08
Enrollment: 1641
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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

Primary outcomes:
measure: Proportion of women whose gestational gain is within the recommended gestational weight gain Institute of Medicine Guidelines in kilograms
timeFrame: 40 weeks
measure: Postpartum weight retention in kg at 12 months postpartum
timeFrame: 1.5 years
Secondary outcomes:
measure: Caloric Intake in Kilocalories
timeFrame: 2 years
measure: Physical activity as an average weekly energy expenditure (METS)
timeFrame: 2 years
measure: Postpartum weight retention at 18 months
timeFrame: 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Isabel D Fernandez, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cornell University
name: Christine M Olson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.