Promoting Healthy Weight Gain During Pregnancy

Phase 3

Completed

• Conditions: Weight Gain
• Interventions: Behavioral: Lifestyle

• Registration Number: NCT01117961
• Lead Sponsor: The Miriam Hospital

Brief Summary

Study goal is to determine whether behavioral lifestyle intervention during pregnancy can reduce the number of women who exceed the Institute of Medicine recommendations for weight gain during pregnancy.

It is hypothesized that the intervention will reduce the number of women who exceed weight gain guidelines relative to standard care. The investigators also expect the intervention to reduce the proportion of women exceeding weight gain guidelines in both normal weight and overweight groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2010-04-15
• Study First Submitted QC: 2010-05-04
• Study First Posted: 2010-05-06
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-30
• Last Update Posted: 2013-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 401

Inclusion Criteria

• non-smoking, adults,
• < 16 weeks gestation

Exclusion Criteria

• medical comorbidities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Intervention	Lifestyle	Lifestyle intervention delivered during pregnancy

Primary Outcome Measures

Name	Time	Method
Percentage of women above the Institute of Medicine Guidelines for gestational weight gain	40 weeks	Objective measures of weight collected by trained staff on calibrated scales at study entry and after delivery to classify women as above or below the Institute of Medicine Guidelines for gestational weight gain

Secondary Outcome Measures

Name	Time	Method
Behavioral measures	40 weeks	The Block Food Frequency questionnaire and Paffenbarger physical activity questionnaire will be used to assess diet and exercise behavior.