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Healthy Moms, a randomized trial to promote and evaluate weight maintenance among obese pregnant women: study design and rationale.


ABSTRACT:

Background

Obesity and excessive weight gain during pregnancy are associated with adverse pregnancy outcomes. Observational studies suggest that minimal or no gestational weight gain (GWG) may minimize the risk of adverse pregnancy outcomes for obese women.

Objective

This report describes the design of Healthy Moms, a randomized trial testing a weekly, group-based, weight management intervention designed to help limit GWG to 3% of weight (measured at the time of randomization) among obese pregnant women (BMI≥30 kg/m(2)). Participants are randomized at 10-20 weeks gestation to either the intervention or a single dietary advice control condition.

Primary outcomes

The study is powered for the primary outcome of total GWG, yielding a target sample size of 160 women. Addit

SUBMITTER: Vesco KK 

PROVIDER: S-EPMC3361519 | biostudies-literature | 2012 Jul

REPOSITORIES: biostudies-literature