Status:
COMPLETED
Pragmatic Randomized Clinical Trial to Limit Weight Gain in Pregnancy and Prevent Obesity
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Pregnancy Weight Gain
Postpartum Weight Retention
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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, we...
Detailed Description
Despite two decades of public health efforts to combat obesity, rates continue to rise and racial disparities persist. There is an urgent need to re-focus obesity prevention efforts onto young adults,...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2025
Estimated Enrollment :
534 Patients enrolled
Trial Details
Trial ID
NCT04724330
Start Date
March 15 2021
End Date
June 25 2025
Last Update
September 10 2025
Active Locations (1)
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1
Johns Hopkins Health System and University
Baltimore, Maryland, United States, 21205