Promoting Healthy Weight Gain During Pregnancy

Weight Gain Clinical Trial

Official title:

Promoting Healthy Weight Gain During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01117961
• Other study ID #: CMTT# 2035-06
• Status: Completed
• Phase: Phase 3
• First received: April 15, 2010
• Last updated: April 30, 2013
• Start date: March 2007
• Est. completion date: May 2012

Study information

• Verified date: April 2013
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• non-smoking, adults,

• < 16 weeks gestation

Exclusion Criteria:

• medical comorbidities

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Weight Gain

Intervention

Behavioral:
• Lifestyle
Behavioral lifestyle intervention targeting diet and physical activity to reduce excessive gestational weight gain

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
The Miriam Hospital	California Polytechnic State University-San Luis Obispo, University of California, Berkeley, Women and Infants Hospital of Rhode Island

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of women above the Institute of Medicine Guidelines for gestational weight gain	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	40 weeks	No
Secondary	Behavioral measures	The Block Food Frequency questionnaire and Paffenbarger physical activity questionnaire will be used to assess diet and exercise behavior.	40 weeks	No