Overview

This trial is active, not recruiting.

Condition obesity
Treatment lifestyle intervention
Sponsor California Polytechnic State University-San Luis Obispo
Collaborator Brown University
Start date November 2012
End date June 2017
Trial size 350 participants
Trial identifier NCT01545934, U01 HL114377A

Summary

The purpose of this study is to study the effects of a multicomponent lifestyle intervention that includes partial meal replacements as a means to prevent excessive gestational weight gain in obese women. The primary hypothesis is that the intervention will reduce the rate of gestational weight gain compared with standard care.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(No Intervention)
(Experimental)
lifestyle intervention
The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy.

Primary Outcomes

Measure
Weight gain per week of observation
time frame: 13 weeks gestation, 35 weeks gestation

Secondary Outcomes

Measure
Offspring weight gain
time frame: 1 week, 6 months, 12 months
Changes in maternal dietary intake
time frame: 13 weeks gestation, 34 weeks gestatation, 6 months postpartum, 12 months postpartum
Changes in offspring dietary intake
time frame: 1 week, 6 months, 12 months
Changes in maternal glucose, insulin, and lipids
time frame: 13 weeks gestation, 34 weeks gestation, 6 months postpartum. 12 months postpartum
Proportion of women exceeding IOM guidelines
time frame: 13 weeks, 40 weeks
Proportion of women at or below prepregnancy weight
time frame: 22-30 weeks post delivery, 48-56 weeks post delivery

Eligibility Criteria

Female participants at least 18 years old.

Inclusion criteria: - Over 18 years old - < 16 weeks gestation - BMI >= 25 - Willing to consent Exclusion Criteria: - Pregnant with Twins - Untreated medical or psychological problem - Inability to be physically active

Additional Information

Official title Preventing Excessive Gestational Weight Gain in Obese Women
Principal investigator Suzanne Phelan, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by California Polytechnic State University-San Luis Obispo.