COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-03-15
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04724330

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age≥18
  2. * Singleton pregnancy
  3. * ≤15 weeks gestation with documented prenatal weight and height in electronic health record
  4. * Body mass index ≥ 25.0 kg/m2
  5. * English-speaking
  6. * Has smartphone, laptop or tablet and willing to use it for this study
  7. * Has email address and willing to use for this study
  1. * BMI \<25 kg/m2
  2. * Multiple fetuses
  3. * History of pre-gestational Type 1 or Type 2 diabetes or taking diabetes medication for treatment of diabetes prior to first prenatal visit
  4. * Prior history of severe preeclampsia, pre-term birth (\< 32 weeks gestation)
  5. * Poorly controlled blood pressure (\> 160/100 mmHg)
  6. * Substance use disorder or positive urine toxicology (except for THC) for illicit substances (screening done as part of routine care)
  7. * Psychiatric hospitalization in last 12 months or diagnosis of severe mental illness that is not well controlled
  8. * Active diagnosis of an eating disorder
  9. * Unable to walk 1 block without pain or shortness of breath
  10. * No email address
  11. * Unable to speak or read in English
  12. * Planning to move in next 12 months

Contacts and Locations

Principal Investigator

Wendy L Bennett, MD, MPH
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Johns Hopkins University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-15
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2021-03-15
Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

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