eMOMS of Rochester



Status:Completed
Conditions:Obesity Weight Loss, Urology
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:18 - 35
Updated:4/21/2016
Start Date:May 2011
End Date:December 2014

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Electronically-Mediated Weight Interventions for Pregnant and Postpartum Women

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.

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
We found this trial at
1
site
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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from
Rochester, NY
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