ClinicalTrials.gov
ClinicalTrials.gov Menu

Promoting Healthy Weight Gain During Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01117961
Recruitment Status : Completed
First Posted : May 6, 2010
Last Update Posted : May 1, 2013
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

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.


Condition or disease Intervention/treatment Phase
Weight Gain Behavioral: Lifestyle Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 401 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Promoting Healthy Weight Gain During Pregnancy
Study Start Date : March 2007
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Percentage of women above the Institute of Medicine Guidelines for gestational weight gain [ Time Frame: 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 :
  1. Behavioral measures [ Time Frame: 40 weeks ]
    The Block Food Frequency questionnaire and Paffenbarger physical activity questionnaire will be used to assess diet and exercise behavior.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • medical comorbidities

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
First Posted: May 6, 2010    Key Record Dates
Last Update Posted: May 1, 2013
Last Verified: April 2013

Keywords provided by Rena R. Wing, The Miriam Hospital:
Excessive gestational weight gain

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