Promoting Health in Pregnancy and Postpartum (HIPP)

Promoting Health in Pregnancy and Postpartum Among Overweight/Obese Women

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Pregnancy
• Intervention / Treatment: Behavioral: Lifestyle Intervention; Behavioral: Standard Care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 228
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • University of South Carolina Prevention Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lifestyle Intervention; The intervention will focus on women gaining the recommended amount of weight, increasing physical activity to 150 minutes per week, and meeting healthy eating guidelines.	Behavioral: Lifestyle Intervention; 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.
Other: Standard Care; Women in the standard care group will attend their regularly scheduled obstetric (OB) visits with their prenatal care providers and will receive monthly mailings and matched number of podcasts.	Behavioral: Standard Care; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational weight gain in pounds	Defined as delivery room weight minus pre-pregnancy weight	Delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational weight gain category	Based on delivery room weight minus pre-pregnancy weight and categorized as Inadequate, adequate, excessive	Delivery
Postpartum weight retention	Defined as weight during 6 month postpartum visit minus pre-pregnancy weight	Weight retained at the 6 month postpartum visit
Postpartum weight retention	Defined as weight during 12 month postpartum visit minus pre-pregnancy weight	Weight retained at the 12 month postpartum visit
Physical Activity	Sense Wear Armband and self-report measure will assess physical activity	32 weeks gestation
Physical Activity	Sense Wear Armband and self-report measure will assess physical activity	6 months postpartum
Physical Activity	Sense Wear Armband and self-report measure will assess physical activity	12 months postpartum
Dietary intake	Two 24-hour dietary recalls using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA-24) will assess dietary intake.	32 weeks gestation
Dietary intake	Two 24-hour dietary recalls using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA-24) will assess dietary intake.	6 months postpartum
Dietary intake	Two 24-hour dietary recalls using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA-24) will assess dietary intake.	12 months postpartum
Depressive Symptoms	Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.	32 weeks gestation
Depressive Symptoms	Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.	6 months postpartum
Depressive Symptoms	Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.	12 months postpartum
Health-Related Quality of Life	The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.	32 weeks gestation
Health-Related Quality of Life	The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.	6 months postpartum
Health-Related Quality of Life	The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.	12 months postpartum
Child Adiposity	Z-scores and skinfolds will be used to measure child adiposity.	6 months postpartum
Child Adiposity	Z-scores and skinfolds will be used to measure child adiposity.	12 months postpartum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy for diet and physical activity	Self-report measure	32 weeks gestation
Self-efficacy for diet and physical activity	Self-report measure	6 months postpartum
Self-efficacy for diet and physical activity	Self-report measure	12 months postpartum
Social support for diet and physical activity	Self-report measure	32 weeks gestation
Social support for diet and physical activity	Self-report measure	6 months postpartum
Social support for diet and physical activity	Self-report measure	12 months postpartum
Decisional balance for diet and physical activity	Self-report measure	32 weeks gestation
Decisional balance for diet and physical activity	Self-report measure	6 months postpartum
Decisional balance for diet and physical activity	Self-report measure	12 months postpartum
Self-regulation for diet and physical activity	Self-report measure	32 weeks gestation
Self-regulation for diet and physical activity	Self-report measure	6 months postpartum
Self-regulation for diet and physical activity	Self-report measure	12 months postpartum

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Sara Wilcox, PhD, University of South Carolina; Principal Investigator: Jihong Liu, Sc.D, University of South Carolina

Publications and helpful links

General Publications

• Wilcox S, Dahl AA, Boutte AK, Liu J, Day K, Turner-McGrievy G, Wingard E. Process evaluation methods and results from the Health in Pregnancy and Postpartum (HIPP) randomized controlled trial. BMC Pregnancy Childbirth. 2022 Oct 26;22(1):794. doi: 10.1186/s12884-022-05107-x.
• Liu J, Wilcox S, Hutto B, Turner-McGrievy G, Wingard E. Effects of a lifestyle intervention on postpartum weight retention among women with elevated weight. Obesity (Silver Spring). 2022 Jul;30(7):1370-1379. doi: 10.1002/oby.23449. Epub 2022 Jun 20.
• Liu J, Wilcox S, Wingard E, Burgis J, Schneider L, Dahl A. Strategies and Challenges in Recruiting Pregnant Women with Elevated Body Mass Index for a Behavioral Lifestyle Intervention. Womens Health Rep (New Rochelle). 2020 Dec 7;1(1):556-565. doi: 10.1089/whr.2020.0089. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: October 6, 2014
• First Submitted That Met QC Criteria: October 6, 2014
• First Posted (Estimate): October 9, 2014

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Pregnancy; Nutrition; Physical activity; Postpartum; Gestational weight gain; Lifestyle intervention
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: R01HD078407 (U.S. NIH Grant/Contract)