Skip to main content
OpenTrials
Completed

NCT Number: NCT02260518

Promoting Health in Pregnancy and Postpartum

The purpose of this study is to examine the impact of a lifestyle intervention on gestational weight gain, postpartum weight loss, and other secondary outcomes relative to a usual care control group.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Behavior Body Weight Body Weight Changes Gestational Weight Gain Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Signs and Symptoms Weight Gain

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina Prevention Research Center

Columbia, South Carolina, 29208, United States

About this study

Our study will address the following specific aims: (1) examine the impact of a lifestyle intervention on gestational weight gain and postpartum weight loss in overweight and obese women, (2) examine the impact of the intervention on physical activity (PA), dietary intake, and quality of life (QOL), (3) examine race differences in total gestational weight gain, PA, dietary intake, and QOL; and (4) examine the impact of the intervention on offspring adiposity.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • White or African American woman
  • Overweight or obese (prepregnancy BMI: 25-45 kg/m2)
  • ≤ 16 wks gestation at screening
  • Age 18-44 years
  • No plan to move out of the greater Columbia area in next 18 months
  • Regular and consistent telephone access
  • Availability for telephone calls
  • Willing to accept random assignment

Exclusion criteria

  • Uncontrolled hypertension
  • Fetal anomaly
  • Taking insulin for diabetes
  • Uncontrolled or untreated thyroid disease
  • Mental health or substance-abuse hospitalization in last 6 months
  • Multiple gestation
  • Persistent bleeding in the first trimester
  • History of more than 3 miscarriages
  • History of an eating disorder or current eating disorder
  • History of an incompetent cervix
  • Physical disability that prevents exercise
  • Told by health care provider not to exercise
  • Any other medical conditions that might be a contraindication to exercise or dietary change

Treatment and study plan

Lifestyle Intervention

Behavioral

During pregnancy, participants complete one face-to-face counseling session, receive 10 behavioral podcasts, and receive weekly phone calls until delivery. Participants will be asked to attend one group session on breastfeeding. Participants will have the opportunity to participate in a private Facebook group during pregnancy and postpartum. During postpartum, participants complete one face-to-face counseling session, receive 16 behavioral podcasts, receive brief weekly check-in telephone calls for six weeks, and receive up to 8 telephone counseling calls through 6 months after delivery.

Standard Care

Behavioral

Women will receive standard nutrition counseling provided by physicians, nurses, nutritionists, and counselors from the Women, Infants, and Children (WIC) program (if applicable). They will receive a monthly study mailing that is educational in nature as well as podcasts related to a healthy pregnancy. During pregnancy, the mailings will focus on tips for a healthy pregnancy and on fetal development. During postpartum the mailings will focus on infant development and parenting. We will select a matched number of podcasts from Pea in the Podcast, commercially available podcasts. All mailings and podcasts will avoid discussion of weight, PA, or diet (except for foods to avoid in pregnancy for safety reasons).

Primary outcomes

  1. Gestational weight gain in pounds

    Time frame: Delivery

    Defined as delivery room weight minus pre-pregnancy weight

Secondary outcomes

  1. Gestational weight gain category

    Time frame: Delivery

    Based on delivery room weight minus pre-pregnancy weight and categorized as Inadequate, adequate, excessive

  2. Postpartum weight retention

    Time frame: Weight retained at the 6 month postpartum visit

    Defined as weight during 6 month postpartum visit minus pre-pregnancy weight

  3. Postpartum weight retention

    Time frame: Weight retained at the 12 month postpartum visit

    Defined as weight during 12 month postpartum visit minus pre-pregnancy weight

  4. Physical Activity

    Time frame: 32 weeks gestation

    Sense Wear Armband and self-report measure will assess physical activity

  5. Physical Activity

    Time frame: 6 months postpartum

    Sense Wear Armband and self-report measure will assess physical activity

  6. Physical Activity

    Time frame: 12 months postpartum

    Sense Wear Armband and self-report measure will assess physical activity

  7. Dietary intake

    Time frame: 32 weeks gestation

    Two 24-hour dietary recalls using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA-24) will assess dietary intake.

  8. Dietary intake

    Time frame: 6 months postpartum

    Two 24-hour dietary recalls using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA-24) will assess dietary intake.

  9. Dietary intake

    Time frame: 12 months postpartum

    Two 24-hour dietary recalls using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA-24) will assess dietary intake.

  10. Depressive Symptoms

    Time frame: 32 weeks gestation

    Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.

  11. Depressive Symptoms

    Time frame: 6 months postpartum

    Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.

  12. Depressive Symptoms

    Time frame: 12 months postpartum

    Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.

  13. Health-Related Quality of Life

    Time frame: 32 weeks gestation

    The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.

  14. Health-Related Quality of Life

    Time frame: 6 months postpartum

    The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.

  15. Health-Related Quality of Life

    Time frame: 12 months postpartum

    The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.

  16. Child Adiposity

    Time frame: 6 months postpartum

    Z-scores and skinfolds will be used to measure child adiposity.

  17. Child Adiposity

    Time frame: 12 months postpartum

    Z-scores and skinfolds will be used to measure child adiposity.

Other outcomes

  1. Self-efficacy for diet and physical activity

    Time frame: 32 weeks gestation

    Self-report measure

  2. Self-efficacy for diet and physical activity

    Time frame: 6 months postpartum

    Self-report measure

  3. Self-efficacy for diet and physical activity

    Time frame: 12 months postpartum

    Self-report measure

  4. Social support for diet and physical activity

    Time frame: 32 weeks gestation

    Self-report measure

  5. Social support for diet and physical activity

    Time frame: 6 months postpartum

    Self-report measure

  6. Social support for diet and physical activity

    Time frame: 12 months postpartum

    Self-report measure

  7. Decisional balance for diet and physical activity

    Time frame: 32 weeks gestation

    Self-report measure

  8. Decisional balance for diet and physical activity

    Time frame: 6 months postpartum

    Self-report measure

  9. Decisional balance for diet and physical activity

    Time frame: 12 months postpartum

    Self-report measure

  10. Self-regulation for diet and physical activity

    Time frame: 32 weeks gestation

    Self-report measure

  11. Self-regulation for diet and physical activity

    Time frame: 6 months postpartum

    Self-report measure

  12. Self-regulation for diet and physical activity

    Time frame: 12 months postpartum

    Self-report measure

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

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

Registry information

Official study title

Promoting Health in Pregnancy and Postpartum Among Overweight/Obese Women

Acronym: HIPP

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Oct 9, 2014
Registry last updated
Apr 28, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.