Promoting Health in Pregnancy and Postpartum

NCT02260518 | Completed

• 1 other identifier: R01HD078407
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Pregnancy; Overweight

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Gestational weight gain in pounds

  Defined as delivery room weight minus pre-pregnancy weight

  Delivery

Secondary Outcomes (17)

• Gestational weight gain category

  Delivery

• Postpartum weight retention

  Weight retained at the 6 month postpartum visit

• Postpartum weight retention

  Weight retained at the 12 month postpartum visit

• Physical Activity

  32 weeks gestation

• Physical Activity

  6 months postpartum

Other Outcomes (12)

• Self-efficacy for diet and physical activity

  32 weeks gestation

• Self-efficacy for diet and physical activity

  6 months postpartum

• Self-efficacy for diet and physical activity

  12 months postpartum

Study Arms (2)

Lifestyle Intervention

EXPERIMENTAL

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

Standard Care

OTHER

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

Interventions

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.

Lifestyle Intervention

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).

Standard Care

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Carolina: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of South Carolina Prevention Research Center

Columbia, South Carolina, 29208, United States

Location

Related Publications (6)

• Wilcox S, Liu J, Sevoyan M, Parker-Brown J, Turner-McGrievy GM. Effects of a behavioral intervention on physical activity, diet, and health-related quality of life in postpartum women with elevated weight: results of the HIPP randomized controlled trial. BMC Pregnancy Childbirth. 2024 Dec 3;24(1):808. doi: 10.1186/s12884-024-07007-8.

  PMID: 39627794 DERIVED

• Wilcox S, Liu J, Turner-McGrievy GM, Boutte AK, Wingard E. Effects of a behavioral intervention on physical activity, diet, and health-related quality of life in pregnant women with elevated weight: results of the HIPP randomized controlled trial. Int J Behav Nutr Phys Act. 2022 Dec 9;19(1):145. doi: 10.1186/s12966-022-01387-w.

  PMID: 36494702 DERIVED

• 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.

  PMID: 36289464 DERIVED

• Wirth MD, Liu J, Wallace MK, McLain AC, Turner-McGrievy GM, Davis JE, Ryan N, Hebert JR. Dietary Inflammatory Index and sleep quality and duration among pregnant women with overweight or obesity. Sleep. 2022 Dec 12;45(12):zsac241. doi: 10.1093/sleep/zsac241.

  PMID: 36173829 DERIVED

• 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.

  PMID: 35722816 DERIVED

• 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.

  PMID: 33786522 DERIVED

MeSH Terms

Conditions

Obesity; Overweight; Gestational Weight Gain; Motor Activity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Weight Gain; Body Weight Changes; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sara Wilcox, PhD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

• Jihong Liu, Sc.D

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 9, 2014
• Study Start: January 1, 2015
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

US (1)