Promoting Healthy Weight Gain During Pregnancy

This study has been completed.
Sponsor:
Collaborators:
California Polytechnic State University-San Luis Obispo
Women and Infants Hospital of Rhode Island
University of California, Berkeley
Information provided by (Responsible Party):
Rena R. Wing, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01117961
First received: April 15, 2010
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Weight Gain
Behavioral: Lifestyle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Promoting Healthy Weight Gain During Pregnancy

Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Percentage of women above the Institute of Medicine Guidelines for gestational weight gain [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    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:
  • Behavioral measures [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    The Block Food Frequency questionnaire and Paffenbarger physical activity questionnaire will be used to assess diet and exercise behavior.


Enrollment: 401
Study Start Date: March 2007
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
Experimental: Intervention
Lifestyle intervention delivered during pregnancy
Behavioral: Lifestyle
Behavioral lifestyle intervention targeting diet and physical activity to reduce excessive gestational weight gain

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • medical comorbidities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by The Miriam Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rena R. Wing, Principal Investigator, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01117961     History of Changes
Other Study ID Numbers: CMTT# 2035-06
Study First Received: April 15, 2010
Last Updated: April 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
Excessive gestational weight gain

Additional relevant MeSH terms:
Body Weight
Weight Gain
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on September 18, 2014