Promoting Health in Pregnancy and Postpartum (HIPP)

• ClinicalTrials.gov Identifier: NCT02260518
• Recruitment Status: Completed
• First Posted: October 9, 2014
• Last Update Posted: April 28, 2021
• Sponsor: University of South Carolina
• Collaborators: National Institutes of Health (NIH); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): Sara Wilcox, University of South Carolina

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.

Condition or disease	Intervention/treatment	Phase
Obesity; Pregnancy; Overweight	Behavioral: Lifestyle Intervention; Behavioral: Standard Care	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 228 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Promoting Health in Pregnancy and Postpartum Among Overweight/Obese Women
• Actual Study Start Date: January 2015
• Actual Primary Completion Date: November 1, 2020
• Actual Study Completion Date: November 1, 2020

Arms and Interventions

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.
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).

Outcome Measures

Primary Outcome Measures :

1. Gestational weight gain in pounds [ Time Frame: Delivery ]
   Defined as delivery room weight minus pre-pregnancy weight

Secondary Outcome Measures :

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 Outcome Measures:

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

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, South Carolina

University of South Carolina Prevention Research Center

Columbia, South Carolina, United States, 29208

Sponsors and Collaborators

University of South Carolina

National Institutes of Health (NIH)

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

Investigators

• Principal Investigator: Sara Wilcox, PhD; University of South Carolina
• Principal Investigator: Jihong Liu, Sc.D; University of South Carolina

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Sara Wilcox, Professor, University of South Carolina
• ClinicalTrials.gov Identifier: NCT02260518
• Other Study ID Numbers: R01HD078407 ( U.S. NIH Grant/Contract ); R01HD078407 ( U.S. NIH Grant/Contract )
• First Posted: October 9, 2014
• Last Update Posted: April 28, 2021
• Last Verified: April 2021

Keywords provided by Sara Wilcox, University of South Carolina:

Gestational weight gain; Lifestyle intervention; Pregnancy; Postpartum; Physical activity; Nutrition

Additional relevant MeSH terms:

Overweight; Overnutrition; Nutrition Disorders; Body Weight