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Completed

NCT Number: NCT02130232

Appropriate Gestational Weight Gain in Overweight/Obese Women

The goal of this trial is to investigate the efficacy of a lifestyle intervention of healthy diet and physical activity for helping overweight/obese pregnant women to achieve appropriate gestational weight gain (GWG) for their prepregnancy body mass index (BMI). The goal of the intervention is to help women achieve the lower bound of the GWG range recommended by the Institutes of Medicine (IOM) for a given prepregnancy BMI category (i.e., 11 lbs for obese women and 15 lbs for overweight women). The lifestyle intervention will be delivered via 2 in-person counseling sessions and 11 telephone contacts with study dieticians trained in motivational interviewing techniques. The lifestyle intervention will be compared to usual medical care. Outcomes will be assessed by trained study personnel at approximately 10 weeks and 32 weeks gestation, within several days of delivery and at 6 months and 12 months postpartum.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Oakland Medical Center, Oakland, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pregnant
  • Pregravid BMI 25 to <40 (as determined from a measured pregravid weight in electronic medical record)

Exclusion criteria

  • Diabetes
  • Cardiovascular disease
  • Gastrointestinal disease
  • Bariatric surgery
  • Lung disease
  • Thyroid disease
  • Eating disorder
  • Cancer
  • Bed rest or Gestational Diabetes in the current pregnancy
  • Planning to get pregnant again or move within 1 year of delivery
  • Substance abuse
  • Serious mental health disorders

Treatment and study plan

Lifestyle Intervention

Behavioral

Usual Care

Other

Primary outcomes

  1. Rate of gestational weight gain per week

    Time frame: From pre-pregnancy weight to last pregnancy weight up to 21 weeks to 42 weeks of pregnancy

  2. Proportion of women exceeding the Institute of Medicine's recommendation for rate of gestational weight gain per week

    Time frame: from pre-pregnancy weight up to 21 weeks to 42 weeks of pregnancy

Secondary outcomes

  1. Total gestational weight gain

    Time frame: from pre-pregnancy weight to last pregnancy weight up to 24 weeks to 42 weeks

  2. Proportion of women exceeding the Institute of Medicine's recommendation for total gestational weight gain per week

    Time frame: From pre-pregnancy weight to last pregnancy weight up to 24 weeks to 42 weeks

  3. Rate of gestational weight gain between study clinical assessments

    Time frame: Rate of gestational weight gain between approximately 10 weeks and 32 weeks gestation (kilograms per week)

  4. Diet - total calories from fat

    Time frame: Change in total calories from fat between study clinical assessments in pregnancy between 10 weeks and 32 weeks gestation

  5. Diet - proportion of calories from fat

    Time frame: Change in proportion of calories from fat between study clinical assessments in pregnancy between 10 weeks and 32 weeks gestation

  6. Physical Activity

    Time frame: Change in physical activity between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)

  7. Metabolic marker - glycemia

    Time frame: Change in glucose between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)

  8. Metabolic marker - insulinemia

    Time frame: Change in insulin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)

  9. Metabolic marker - lipids

    Time frame: Change in lipids between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)

  10. Metabolic marker - leptin

    Time frame: Change in leptin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)

  11. Metabolic marker - adiponectin

    Time frame: Change in adiponectin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

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

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
May 5, 2014
Registry last updated
Apr 7, 2020

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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