eMOMS of Rochester

Gestational Weight Gain Clinical Trial

— eMOMS  

Official title:

Electronically-Mediated Weight Interventions for Pregnant and Postpartum Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01331564
• Other study ID #: HL096760
• Status: Completed
• Phase: Phase 3
• First received: March 31, 2011
• Last updated: November 30, 2015
• Start date: May 2011
• Est. completion date: December 2014

Study information

• Verified date: November 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1641
• Est. completion date: December 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Body Weight
• Gestational Weight Gain
• Postpartum Weight Retention
• Weight Gain

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women whose gestational gain is within the recommended gestational weight gain Institute of Medicine Guidelines in kilograms	Gestational weight gain is the result of the last predelivery weight minus the prepregnancy weight (or early pregnancy weight).	40 weeks	No
Primary	Postpartum weight retention in kg at 12 months postpartum	The difference between the weight at 12 months postpartum and the pre-pregnancy weight (or early pregnancy weight. Participants will be followed for a maximum of 2 years from recruitment in early pregnancy to 18 months postpartum. The final outcome in the postpartum period is postpartum weight retention at 18 months. Interim measure of postpartum weight will be collected at 6 and 12 months for analyses. The primary hypothesis for the postpartum period is weight retention at 12 months postpartum.	1.5 years	No
Secondary	Caloric Intake in Kilocalories	Caloric intake will be calculated based on the average food intake assessed by 2 24-hour dietary recall.	2 years	No
Secondary	Physical activity as an average weekly energy expenditure (METS)	Physical activity during pregnancy is measured using the Pregnancy Physical Activity Questionnaire and during postpartum using the Global Physical Activity Questionnaire.	2 years	No
Secondary	Postpartum weight retention at 18 months	The difference between the weight at 18 months postpartum and the prepregnancy weight (or early pregnancy weight). Participants will be followed for a maximum of 2 years from recruitment in early pregnancy to 18 months postpartum. The final outcome in the postpartum period is postpartum weight retention at 18 months. Interim measure of postpartum weight will be collected at 6 and 12 months for analyses. The primary hypothesis for the postpartum period is weight retention at 12 months postpartum	2 years	No