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OpenTrials
Completed

NCT Number: NCT01117961

Promoting Healthy Weight Gain During Pregnancy

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.

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Key information

Conditions

Weight Gain Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • medical comorbidities

Treatment and study plan

Lifestyle

Behavioral

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

  • California Polytechnic State University-San Luis Obispo
  • University of California, Berkeley
  • Women and Infants Hospital of Rhode Island

Registry information

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
May 6, 2010
Registry last updated
May 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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