Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2022 Feb:113:106647.
doi: 10.1016/j.cct.2021.106647. Epub 2021 Dec 8.

Healthy for Two/Healthy for You: Design and methods for a pragmatic randomized clinical trial to limit gestational weight gain and prevent obesity in the prenatal care setting

Wendy L Bennett  1 , Janelle W Coughlin  2 , Janice Henderson  3 , Stephen Martin  3 , Golsa M Yazdy  3 , Emmanuel F Drabo  4 , Nakiya N Showell  5 , Christine McKinney  6 , Lindsay Martin  6 , Arlene Dalcin  6 , Rachel Sanders  6 , Nae-Yuh Wang  6
Affiliations
Randomized Controlled Trial

Healthy for Two/Healthy for You: Design and methods for a pragmatic randomized clinical trial to limit gestational weight gain and prevent obesity in the prenatal care setting

Wendy L Bennett et al. Contemp Clin Trials. 2022 Feb.

Abstract

Objective: To compare the effect of Healthy for Two/Healthy for You (H42/H4U), a health coaching program, in prenatal care clinics that serve a racially and economically diverse population, on total gestational weight gain (GWG) (vs. usual care). We hypothesize that compared to usual prenatal care, intervention participants will have lower GWG and lower rates of gestational diabetes mellitus (GDM).

Methods: We report the rationale and design of a pragmatic, parallel arm randomized clinical trial with 380 pregnant patients ≤15 weeks gestation with overweight or obesity from one of 6 academic and community-based obstetrics practices, randomized to either H42/H4U or usual prenatal care in a 1:1 ratio. The study duration is early pregnancy to 6 months postpartum. The primary outcome is total GWG, calculated as the difference between first clinic-assessed pregnancy weight and the weight at 37 weeks gestation. Key maternal and infant secondary outcomes include GDM incidence, weight retention at 6 months postpartum, infant weight, maternal health behaviors and wellness.

Conclusions: This pragmatic clinical trial embeds a pregnancy health coaching program into prenatal care to allow parallel testing compared to usual prenatal care on the outcome of total GWG. The real-world design provides an approach to enhance its sustainability beyond the trial to ultimately improve maternal/child health outcomes and reduce future obesity.

Trial registration: The study was first registered at clinicaltrials.gov on 1/26/21 (NCT04724330).

Keywords: Gestational weight gain; Lifestyle intervention; Obesity; Overweight; Postpartum weight retention; Pregnancy.

PubMed Disclaimer

Conflict of interest statement

Declaration of Competing Interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Figure 1.
Figure 1.
Screen shot of the Best Practice Advisory used to prompt clinic-based recruitment
Figure 2.
Figure 2.
Screen shots of the H42/H4U platform with panels A-C
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Hales CM, Fryar CD, Carroll MD, Freedman DS, Ogden CL. Trends in Obesity and Severe Obesity Prevalence in US Youth and Adults by Sex and Age, 2007–2008 to 2015–2016. Jama Apr 24 2018;319(16):1723–1725. doi:10.1001/jama.2018.3060 - DOI - PMC - PubMed
    1. Ogden CL, Fryar CD, Hales CM, Carroll MD, Aoki Y, Freedman DS. Differences in Obesity Prevalence by Demographics and Urbanization in US Children and Adolescents, 2013–2016. Jama Jun 19 2018;319(23):2410–2418. doi:10.1001/jama.2018.5158 - DOI - PMC - PubMed
    1. Dietz WH. Obesity and Excessive Weight Gain in Young Adults: New Targets for Prevention. Jama Jul 18 2017;318(3):241–242. doi:10.1001/jama.2017.6119 - DOI - PubMed
    1. Dutton GR, Kim Y, Jacobs DR Jr., et al. 25-year weight gain in a racially balanced sample of U.S. adults: The CARDIA study. Obesity (Silver Spring, Md) Sep 2016;24(9):1962–8. doi:10.1002/oby.21573 - DOI - PMC - PubMed
    1. Zheng Y, Manson JE, Yuan C, et al. Associations of Weight Gain From Early to Middle Adulthood With Major Health Outcomes Later in Life. Jama Jul 18 2017;318(3):255–269. doi:10.1001/jama.2017.7092 - DOI - PMC - PubMed

Publication types

Associated data