search
Back to results

Promoting Healthy Weight Gain During Pregnancy

Primary Purpose

Weight Gain

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Lifestyle
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Gain focused on measuring Excessive gestational weight gain

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • medical comorbidities

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    control

    Intervention

    Arm Description

    Lifestyle intervention delivered during pregnancy

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 15, 2010
    Last Updated
    April 30, 2013
    Sponsor
    The Miriam Hospital
    Collaborators
    California Polytechnic State University-San Luis Obispo, Women and Infants Hospital of Rhode Island, University of California, Berkeley
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01117961
    Brief Title
    Promoting Healthy Weight Gain During Pregnancy
    Official Title
    Promoting Healthy Weight Gain During Pregnancy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2007 (undefined)
    Primary Completion Date
    May 2012 (Actual)
    Study Completion Date
    May 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Miriam Hospital
    Collaborators
    California Polytechnic State University-San Luis Obispo, Women and Infants Hospital of Rhode Island, University of California, Berkeley

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weight Gain
    Keywords
    Excessive gestational weight gain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Factorial Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    401 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    control
    Arm Type
    No Intervention
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Lifestyle intervention delivered during pregnancy
    Intervention Type
    Behavioral
    Intervention Name(s)
    Lifestyle
    Intervention Description
    Behavioral lifestyle intervention targeting diet and physical activity to reduce excessive gestational weight gain
    Primary Outcome Measure Information:
    Title
    Percentage of women above the Institute of Medicine Guidelines for gestational weight gain
    Description
    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
    Time Frame
    40 weeks
    Secondary Outcome Measure Information:
    Title
    Behavioral measures
    Description
    The Block Food Frequency questionnaire and Paffenbarger physical activity questionnaire will be used to assess diet and exercise behavior.
    Time Frame
    40 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: non-smoking, adults, < 16 weeks gestation Exclusion Criteria: medical comorbidities

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28525293
    Citation
    Mercado A, Marquez B, Abrams B, Phipps MG, Wing RR, Phelan S. Where Do Women Get Advice About Weight, Eating, and Physical Activity During Pregnancy? J Womens Health (Larchmt). 2017 Sep;26(9):951-956. doi: 10.1089/jwh.2016.6078. Epub 2017 May 19.
    Results Reference
    derived
    PubMed Identifier
    24284438
    Citation
    Phelan S, Phipps MG, Abrams B, Darroch F, Grantham K, Schaffner A, Wing RR. Does behavioral intervention in pregnancy reduce postpartum weight retention? Twelve-month outcomes of the Fit for Delivery randomized trial. Am J Clin Nutr. 2014 Feb;99(2):302-11. doi: 10.3945/ajcn.113.070151. Epub 2013 Nov 27.
    Results Reference
    derived
    PubMed Identifier
    21310836
    Citation
    Phelan S, Phipps MG, Abrams B, Darroch F, Schaffner A, Wing RR. Randomized trial of a behavioral intervention to prevent excessive gestational weight gain: the Fit for Delivery Study. Am J Clin Nutr. 2011 Apr;93(4):772-9. doi: 10.3945/ajcn.110.005306. Epub 2011 Feb 10.
    Results Reference
    derived

    Learn more about this trial

    Promoting Healthy Weight Gain During Pregnancy

    We'll reach out to this number within 24 hrs