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OpenTrials
Completed

NCT Number: NCT00950235

Weight Management for Improved Pregnancy Outcomes

This study will examine the safety and effectiveness of a dietary intervention in pregnant women. Women who are obese will be invited to participate. The control arm will receive routine prenatal care and one in-person nutritional and dietary counseling session to promote healthy eating during their pregnancy. The intervention arm will receive a more intensive dietary program that will include in-person counseling and group support sessions. The goal of the intervention will be weight maintenance (weight at 2 weeks after delivery should be within 3% of baseline weight) and avoidance of postpartum weight retention

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI 30 or more
  • Less than 20 weeks gestation
  • member of Kaiser Permanente Northwest (NW)
  • receive pre-natal care at Kaiser Permanente NW
  • speaks English

Exclusion criteria

  • no current treatment for cancer
  • no bariatric surgery
  • no current renal disease
  • no multiple birth anticipated
  • no hyperemesis requiring hospitalization
  • no diabetes (type 1 or 2)

Treatment and study plan

Weight management

Behavioral

Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy

Usual Care

Other

Standard nutrition counseling from Health Plan

Primary outcomes

  1. Maternal Weight Change

    Time frame: baseline to 2 weeks post partum

    We chose the weight at 2 weeks postpartum, rather than at an end point during pregnancy, to avoid the contribution of products of conception, maternal edema, and increased maternal blood volume to the weight gain.

Secondary outcomes

  1. Pregnancy Weight Change

    Time frame: baseline to 34 weeks gestation

  2. Large for Gestational Age (LGA)

    Time frame: At birth

    Large-for-gestational-age defined as weight greater than the 90th percentile for gestational age at birth.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: Healthy Moms

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Jul 31, 2009
Registry last updated
Jul 9, 2015

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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