Health coaching program to manage weight gain during pregnancy
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
This study is testing a remote health coaching program to help pregnant women manage weight gain and improve health for themselves and their babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 380 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT04724330 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the Healthy for Two, Healthy for You (H42/H4U) program, which provides remote health coaching to pregnant women to limit weight gain and prevent obesity-related complications. The intervention utilizes motivational interviewing and a web-based platform to support behavior change among participants. Conducted in Johns Hopkins prenatal care clinics, the trial aims to assess both the health outcomes for mothers and their children, as well as the feasibility of implementing this program in diverse populations. The study focuses on women with a body mass index of 25 or higher who are within the first 15 weeks of their pregnancy.
Who should consider this trial
Good fit: Ideal candidates for this study are English-speaking women aged 18 and older, with a body mass index of 25 or higher, who are within 15 weeks of a singleton pregnancy.
Not a fit: Patients with a body mass index below 25, multiple fetuses, or a history of severe pregnancy complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce gestational weight gain and the incidence of gestational diabetes, leading to healthier outcomes for mothers and their children.
How similar studies have performed: Previous studies have shown success in limiting gestational weight gain through behavioral interventions, indicating that this approach has potential for effectiveness.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Health System and University — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Wendy L Bennett, MD, MPH — Johns Hopkins University
- Study coordinator: Wendy L Bennett, MD, MPH
- Email: wendy.bennett@jhmi.edu
- Phone: 4105026081
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.