eMOMS of Rochester

Completed · Phase 3

Conditions studied: Gestational Weight Gain, Postpartum Weight Retention

In brief

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.

Key facts

Study ID

NCT01331564

Run by

University of Rochester

People needed

1641

Starts

2011-05-01

Expected to finish

2014-12-01

Last updated by the study team

2015-12-02

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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