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

Tracking Information

• First Submitted Date: October 6, 2014
• First Posted Date: October 9, 2014
• Last Update Posted Date: April 28, 2021
• Actual Study Start Date: January 2015
• Actual Primary Completion Date: November 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 18, 2015)

Gestational weight gain in pounds [ Time Frame: Delivery ]

Defined as delivery room weight minus pre-pregnancy weight

Original Primary Outcome Measures (submitted: October 6, 2014)

Gestational weight gain in pounds [ Time Frame: <15 weeks, 32 weeks ]

Defined as delivery room weight minus pre-pregnancy weight

Current Secondary Outcome Measures (submitted: April 26, 2021)

• Gestational weight gain category [ Time Frame: Delivery ]
  Based on delivery room weight minus pre-pregnancy weight and categorized as Inadequate, adequate, excessive
• 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
• 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
• Physical Activity [ Time Frame: 32 weeks gestation ]
  Sense Wear Armband and self-report measure will assess physical activity
• Physical Activity [ Time Frame: 6 months postpartum ]
  Sense Wear Armband and self-report measure will assess physical activity
• Physical Activity [ Time Frame: 12 months postpartum ]
  Sense Wear Armband and self-report measure will assess physical activity
• 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.
• 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.
• 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.
• Depressive Symptoms [ Time Frame: 32 weeks gestation ]
  Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.
• Depressive Symptoms [ Time Frame: 6 months postpartum ]
  Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.
• Depressive Symptoms [ Time Frame: 12 months postpartum ]
  Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.
• 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.
• 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.
• 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.
• Child Adiposity [ Time Frame: 6 months postpartum ]
  Z-scores and skinfolds will be used to measure child adiposity.
• Child Adiposity [ Time Frame: 12 months postpartum ]
  Z-scores and skinfolds will be used to measure child adiposity.

Original Secondary Outcome Measures (submitted: October 6, 2014)

• Gestational weight gain category [ Time Frame: <15 weeks, 32 weeks ]
  Inadequate, adequate, excessive
• Postpartum weight retention [ Time Frame: 6 months postpartum, 12 months postpartum ]
  Defined as weight during postpartum visit minus pre-pregnancy weight
• Physical Activity [ Time Frame: <15 weeks, 32 weeks, 6 months postpartum, 12 months postpartum ]
  SenseWear Armband and self-report measure will assess physical activity
• Dietary intake [ Time Frame: <15 weeks, 32 weeks, 6 months postpartum, 12 months postpartum ]
  Two 24-hours dietary recalls using ASA-24 will assess dietary intake.
• Depressive Symptoms [ Time Frame: <15 weeks, 32 weeks, 6 months postpartum, 12 months postpartum ]
  Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.
• Quality of Life [ Time Frame: <15 weeks, 32 weeks, 6 months postpartum, 12 months postpartum ]
  The SF-12 questionnaire will be used to assess quality of life.
• Child Adiposity [ Time Frame: 6 months postpartum, 12 months postpartum ]
  Z-scores and skinfolds will be used to measure child adiposity.

Current Other Pre-specified Outcome Measures (submitted: November 18, 2015)

• Self-efficacy for diet and physical activity [ Time Frame: 32 weeks gestation ]
  Self-report measure
• Self-efficacy for diet and physical activity [ Time Frame: 6 months postpartum ]
  Self-report measure
• Self-efficacy for diet and physical activity [ Time Frame: 12 months postpartum ]
  Self-report measure
• Social support for diet and physical activity [ Time Frame: 32 weeks gestation ]
  Self-report measure
• Social support for diet and physical activity [ Time Frame: 6 months postpartum ]
  Self-report measure
• Social support for diet and physical activity [ Time Frame: 12 months postpartum ]
  Self-report measure
• Decisional balance for diet and physical activity [ Time Frame: 32 weeks gestation ]
  Self-report measure
• Decisional balance for diet and physical activity [ Time Frame: 6 months postpartum ]
  Self-report measure
• Decisional balance for diet and physical activity [ Time Frame: 12 months postpartum ]
  Self-report measure
• Self-regulation for diet and physical activity [ Time Frame: 32 weeks gestation ]
  Self-report measure
• Self-regulation for diet and physical activity [ Time Frame: 6 months postpartum ]
  Self-report measure
• Self-regulation for diet and physical activity [ Time Frame: 12 months postpartum ]
  Self-report measure

Original Other Pre-specified Outcome Measures (submitted: October 6, 2014)

• Self-efficacy for diet and physical activity [ Time Frame: <15 weeks, 32 weeks, 6 months postpartum, 12 months postpartum ]
  Self-report measure
• Social support for diet and physical activity [ Time Frame: <15 weeks, 32 weeks, 6 months postpartum, 12 months postpartum ]
  Self-report measure
• Decisional balance for diet and physical activity [ Time Frame: <15 weeks, 32 weeks, 6 months postpartum, 12 months postpartum ]
  Self-report measure
• Self-regulation for diet and physical activity [ Time Frame: <15 weeks, 32 weeks, 6 months postpartum, 12 months postpartum ]
  Self-report measure

Descriptive Information

• Brief Title: Promoting Health in Pregnancy and Postpartum
• Official Title: Promoting Health in Pregnancy and Postpartum Among Overweight/Obese Women
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention

Condition

• Obesity
• Pregnancy
• Overweight

Intervention

• 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.
• 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).

Study Arms

• 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.
  Intervention: Behavioral: Lifestyle Intervention
• 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.
  Intervention: Behavioral: Standard Care

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 15, 2019): 228
• Original Estimated Enrollment (submitted: October 6, 2014): 500
• Actual Study Completion Date: November 1, 2020
• Actual Primary Completion Date: November 1, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 44 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02260518
• Other Study ID Numbers: R01HD078407( U.S. NIH Grant/Contract ); R01HD078407 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sara Wilcox, University of South Carolina
• Original Responsible Party: University of South Carolina
• Current Study Sponsor: University of South Carolina
• Original Study Sponsor: Same as current

Collaborators

• 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

• PRS Account: University of South Carolina
• Verification Date: April 2021