Pragmatic Randomized Clinical Trial to Limit Weight Gain in Pregnancy and Prevent Obesity

Description

Healthy for Two, Healthy for You (H42/H4U) is an innovative evidence-based pregnancy/postpartum health coach intervention that is remotely-delivered (phone coaching using motivational interviewing, web-based platform, mobile phone behavioral tracking). The aim of this randomized controlled trial (RCT) is to embed H42/H4U into Johns Hopkins prenatal care clinics that serve a racially and economically diverse population, leveraging existing staff as trained health coaches to test its effectiveness and implementation. The investigators hypothesize that women in the H42/H4U arm will have lower gestational weight gain and lower rates of gestational diabetes, without an increase in low birth weight infants, and that implementation into the investigators' prenatal care clinics will be feasible and scalable.

Conditions

Pregnancy Weight Gain, Postpartum Weight Retention, Childhood Obesity, Gestational Diabetes, Overweight and Obesity

Talk to us

Study Overview

On this page

Study Details

Study overview

Healthy for Two, Healthy for You (H42/H4U) is an innovative evidence-based pregnancy/postpartum health coach intervention that is remotely-delivered (phone coaching using motivational interviewing, web-based platform, mobile phone behavioral tracking). The aim of this randomized controlled trial (RCT) is to embed H42/H4U into Johns Hopkins prenatal care clinics that serve a racially and economically diverse population, leveraging existing staff as trained health coaches to test its effectiveness and implementation. The investigators hypothesize that women in the H42/H4U arm will have lower gestational weight gain and lower rates of gestational diabetes, without an increase in low birth weight infants, and that implementation into the investigators' prenatal care clinics will be feasible and scalable.

Healthy for 2/Healthy for U: A Pragmatic Randomized Clinical Trial to Limit Gestational Weight Gain and Prevent Obesity in Johns Hopkins Prenatal Care Practices

Pragmatic Randomized Clinical Trial to Limit Weight Gain in Pregnancy and Prevent Obesity

Condition
Pregnancy Weight Gain
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins Health System and University, Baltimore, Maryland, United States, 21205

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age≥18
  • * Singleton pregnancy
  • * ≤15 weeks gestation with documented prenatal weight and height in electronic health record
  • * Body mass index ≥ 25.0 kg/m2
  • * English-speaking
  • * Has smartphone, laptop or tablet and willing to use it for this study
  • * Has email address and willing to use for this study
  • * BMI \<25 kg/m2
  • * Multiple fetuses
  • * History of pre-gestational Type 1 or Type 2 diabetes or taking diabetes medication for treatment of diabetes prior to first prenatal visit
  • * Prior history of severe preeclampsia, pre-term birth (\< 32 weeks gestation)
  • * Poorly controlled blood pressure (\> 160/100 mmHg)
  • * Substance use disorder or positive urine toxicology (except for THC) for illicit substances (screening done as part of routine care)
  • * Psychiatric hospitalization in last 12 months or diagnosis of severe mental illness that is not well controlled
  • * Active diagnosis of an eating disorder
  • * Unable to walk 1 block without pain or shortness of breath
  • * No email address
  • * Unable to speak or read in English
  • * Planning to move in next 12 months

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Wendy L Bennett, MD, MPH, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2025-08-30