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Promoting Health in Pregnancy and Postpartum (HIPP)

Primary Purpose

Obesity, Pregnancy, Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Intervention
Standard Care
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Gestational weight gain, Lifestyle intervention, Pregnancy, Postpartum, Physical activity, Nutrition

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of South Carolina Prevention Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Lifestyle Intervention

Standard Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Gestational weight gain in pounds
Defined as delivery room weight minus pre-pregnancy weight

Secondary Outcome Measures

Gestational weight gain category
Based on delivery room weight minus pre-pregnancy weight and categorized as Inadequate, adequate, excessive
Postpartum weight retention
Defined as weight during 6 month postpartum visit minus pre-pregnancy weight
Postpartum weight retention
Defined as weight during 12 month postpartum visit minus pre-pregnancy weight
Physical Activity
Sense Wear Armband and self-report measure will assess physical activity
Physical Activity
Sense Wear Armband and self-report measure will assess physical activity
Physical Activity
Sense Wear Armband and self-report measure will assess physical activity
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.
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.
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.
Depressive Symptoms
Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.
Depressive Symptoms
Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.
Depressive Symptoms
Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.
Health-Related Quality of Life
The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.
Health-Related Quality of Life
The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.
Health-Related Quality of Life
The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.
Child Adiposity
Z-scores and skinfolds will be used to measure child adiposity.
Child Adiposity
Z-scores and skinfolds will be used to measure child adiposity.

Full Information

First Posted
October 6, 2014
Last Updated
April 26, 2021
Sponsor
University of South Carolina
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02260518
Brief Title
Promoting Health in Pregnancy and Postpartum
Acronym
HIPP
Official Title
Promoting Health in Pregnancy and Postpartum Among Overweight/Obese Women
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Pregnancy, Overweight
Keywords
Gestational weight gain, Lifestyle intervention, Pregnancy, Postpartum, Physical activity, Nutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
228 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Wilcox, PhD
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jihong Liu, Sc.D
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Carolina Prevention Research Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36289464
Citation
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.
Results Reference
derived
PubMed Identifier
35722816
Citation
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.
Results Reference
derived
PubMed Identifier
33786522
Citation
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.
Results Reference
derived

Learn more about this trial

Promoting Health in Pregnancy and Postpartum

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