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Completed

NCT Number: NCT02520167

Partnership to Improve Nutrition and Adiposity in Prenatal Clinical Care: a Pilot and Feasibility Study

This study will pilot and assess feasibility of a prenatal intervention for obese pregnant women based on the Diabetes Prevention Program (DPP). Intervention group participants will meet with a clinic dietitian for 15 minutes at every prenatal appointment to complete a DPP-based curriculum and receive breastfeeding education. Control group participants will receive usual prenatal care. Outcomes include reach and dose of the intervention, gestational weight gain, dietary intake, physical activity, and breastfeeding in the first 6 weeks postpartum.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Denver Health Eastside Family Health Center

Denver, Colorado, 80205, United States

About this study

This study will pilot and test feasibility of a prenatal lifestyle intervention designed to limit gestational weight gain and prevent gestational diabetes. The intervention is based on the Diabetes Prevention Program lifestyle intervention, will include prenatal breastfeeding education and online peer group support, and will be integrated into the participants' regular prenatal appointments. Women (n=24) will be enrolled in early pregnancy. After baseline assessments (demographics, maternal diet, physical activity, mental health), women randomized equally to the intervention or usual care conditions. Further data collection will occur at approximately 24 weeks gestation, 36 weeks gestation, and 6 weeks postpartum, and clinical data (weight, pregnancy and obstetric complications) will be abstracted from medical records at the end of the study. Outcomes include reach and dose of the intervention, gestational weight gain, dietary intake, physical activity, and breastfeeding in the first 6 weeks postpartum. The investigators hypothesize that the intervention will reduce gestational weight gain, improve maternal dietary intake, increase total energy expenditure, and increase breastfeeding exclusivity in the first 6 weeks postpartum.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Singleton pregnancies of <12 weeks gestation
  • Pre-pregnant body mass index >=30
  • Speak and understand English
  • Plan to continue care at the clinic through pregnancy and postpartum

Exclusion criteria

  • Pre-existing diabetes
  • History of serious chronic illnesses
  • History of prior gestational diabetes
  • Prior delivery at <37 weeks gestation
  • Prior delivery of infant weighing <2500g

Treatment and study plan

dietary and lifestyle counseling

Behavioral

Dietary and lifestyle education; Peer group support.

Primary outcomes

  1. Gestational weight gain

    Time frame: 40 weeks

    Weight change from pre-pregnancy to time of delivery

Secondary outcomes

  1. Maternal fruit intake

    Time frame: Assessed from 12 weeks gestation through 6 weeks postpartum

    Change in daily servings of fruit from early pregnancy to mid-pregnancy, late pregnancy, and postpartum

  2. Maternal vegetable intake

    Time frame: Assessed from 12 weeks gestation through 6 weeks postpartum

    Change in daily servings of vegetables from early pregnancy to mid-pregnancy, late pregnancy, and postpartum

  3. Maternal whole grains intake

    Time frame: Assessed from 12 weeks gestation through 6 weeks postpartum

    Change in daily servings of whole grains from early pregnancy to mid-pregnancy, late pregnancy, and postpartum

  4. Maternal solid fats intake

    Time frame: Assessed from 12 weeks gestation through 6 weeks postpartum

    Change in daily servings of solid fats from early pregnancy to mid-pregnancy, late pregnancy, and postpartum

  5. Maternal added sugars intake

    Time frame: Assessed from 12 weeks gestation through 6 weeks postpartum

    Change in daily servings of added sugars from early pregnancy to mid-pregnancy, late pregnancy, and postpartum

  6. Maternal physical activity

    Time frame: Assessed from 12 weeks gestation through 6 weeks postpartum

    Change in total estimated energy expenditure from early pregnancy to mid-pregnancy, late pregnancy, and postpartum

  7. Exclusive breastfeeding

    Time frame: Assessed at 6 weeks postpartum

    Measured as exclusive breastfeeding (no formula, no complementary foods) in the first 6 weeks postpartum

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Denver Health and Hospital Authority

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 11, 2015
Registry last updated
Jul 13, 2017

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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