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

Launched by JOHNS HOPKINS UNIVERSITY · Jan 22, 2021

Keywords

ClinConnect Summary

This clinical trial, called Healthy for Two, Healthy for You (H42/H4U), is studying a new way to help pregnant women manage their weight and improve their health during and after pregnancy. The program involves coaching over the phone and using an online platform to track behavior, making it easy for participants to access support. The goal is to see if this approach can help women gain less weight during pregnancy and reduce the chances of developing gestational diabetes, without affecting the health of their babies.

To be eligible for this study, women must be at least 18 years old, in the early stages of a single pregnancy (less than 15 weeks along), and have a body mass index (BMI) of 25 or higher, indicating they are overweight. Participants should be comfortable using a smartphone or computer and able to communicate in English. If selected, participants can expect to receive personalized coaching and resources to help them stay healthy throughout their pregnancy. The trial is currently recruiting participants and aims to implement this coaching program in diverse clinics, making it accessible to many women.

Gender

FEMALE

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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