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Completed

NCT Number: NCT01643356

Interventions to Reduce Excess Weight Gain in Pregnancy

The study will use a comprehensive behavioral intervention adapted for pregnant women to change dietary intake, eating behavior and physical activity. The central hypothesis of this study is that the intervention will reduce excess gestational weight gain and achieve clinical and metabolic benefits in obese and overweight pregnant women and their infants over the first year of life.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center, Boston, Massachusetts, 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

  • Age 18-45 years
  • In first trimester of pregnancy
  • Must be willing to not join any other weight control program while in the study
  • BMI of 25-40 kg/m2
  • Willingness and ability to attend support group meetings either in person or via web
  • Must be able to read, speak, and understand English

Exclusion criteria

  • Carrying multiple fetuses
  • Gestational diabetes mellitus at study entry
  • Type 2 diabetes mellitus or blood glucose >125 mg/dl at screening
  • Self reported current substance abuse
  • Current smoking
  • Alchol consumption of more than 1 drink per day
  • Preexisting medical conditions (includes bariatric surgery) or use of medications that would impact study involvement or outcomes testing
  • Eating disorder in the past 2 years
  • Depression or diagnosis of bipolar disorder
  • Concurrent participation in any other research study that would impact participation in this investigation

Treatment and study plan

Intervention to reduce excess weight gain during pregnancy

Behavioral

Intervention includes meetings with a nutrition counselor and/or psychologist where individualized eating plans will be developed and reviewed, and regular group meetings during which information about healthy eating for weight management will be discussed.

Primary outcomes

  1. Maternal and Infant Body Weight Change

    Time frame: From first trimester through 1 year post-partum

    • Maternal non-fasting weight measured at all prenatal clinic and study visits.
    • Infant weight measured at birth and all pediatric clinic visits through 1 year.

Secondary outcomes

  1. Infant Outcomes

    Time frame: From birth through first year

    • Body composition (i.e. length, head circumference, skinfold thickness, waist circumference) changes through the first year.
    • Characteristics at birth including Apgar score, gestational age.
    • Dietary intake and food preferences at 1 year.

  2. Maternal and Perinatal Outcomes

    Time frame: First trimester through 1 year post-partum

    • Rates of cesarean delivery, gestational hypertension/preeclampsia, preterm birth, birth complications.
    • Fasting blood glucose and insulin concentrations throughout pregnancy.
    • Body composition and energy requirements at baseline and 24-28 weeks of pregnancy.
    • Total energy expenditure at 24-28 weeks of pregnancy.
    • Rate of breastfeeding and breastfeeding practices at 1, 3, 6, and 12 months post-partum.

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Registry information

Official study title

Interventions to Reduce Excess Weight Gain in Pregnancy in Overweight and Obese Mothers

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jul 18, 2012
Registry last updated
May 10, 2016

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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