eMOMS of Rochester

University of Rochester

Status and phase: Completed; Phase 3

Conditions: Postpartum Weight Retention; Gestational Weight Gain

Treatments: Behavioral: electronic intervention during pregnancy and postpartum; Behavioral: Control; Behavioral: electronic intervention during pregnancy

Study type: Interventional

Funder types: Other

Identifiers

NCT01331564

HL096760

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,641 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,641 participants in 3 patient groups, including a placebo group

electronic intervention group 2

Experimental group

Description:

(e-intervention 2) receives a behavioral intervention through a website during pregnancy and until 18 months postpartum

Treatment:

Behavioral: electronic intervention during pregnancy and postpartum

electronic intervention group 1

Experimental group

Description:

(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

Treatment:

Behavioral: electronic intervention during pregnancy

Control

Placebo Comparator group

Treatment:

Behavioral: Control