StEP OUT for Healthy Weight
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an online program called StEP OUT, which aims to teach healthy habits to pregnant women and new mothers to prevent early child obesity in Latino families. The program will be compared with a control group receiving infant safety education. Participants will either join group chats and video calls or receive helpful text messages, depending on their assigned group. The trial seeks expecting mothers who are at least 24 weeks pregnant, identify as Hispanic/Latinx, speak English or Spanish, and are eligible for New York State Medicaid benefits. As an unphased study, this trial offers a unique opportunity to contribute to important research that could benefit future families.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.
What prior data suggests that this online program is safe for participants?
Research has shown that programs like StEP OUT, which focus on nutrition and healthy habits, are generally safe for participants. Programs such as SNAP-Ed have been widely used to help people make healthier food choices, with no reports of negative effects from these educational tools. This suggests that StEP OUT is likely well-tolerated. Participants in the trial will engage in group text chats and video calls, common and safe methods for sharing information and support. Overall, evidence supports the safety of joining this type of educational program.12345
Why are researchers excited about this trial?
Researchers are excited about the StEP OUT program because it offers a fresh approach to promoting healthy weight management through online nutrition education combined with parenting support. Unlike traditional methods that might rely on in-person counseling or printed materials, StEP OUT leverages the accessibility of the internet and the connectedness of group chats to engage participants. This digital delivery method could make it easier for busy parents to access vital information and support, potentially leading to more significant lifestyle changes and better health outcomes for both parents and their infants. Additionally, the use of periodic text messages in the Infant Safety Education arm adds a layer of convenience and ongoing support that traditional methods may lack.
What evidence suggests that this trial's treatments could be effective for preventing early child obesity?
Research shows that the StEP OUT program, a treatment in this trial, offers online lessons about nutrition and parenting and can help reduce the risk of childhood obesity. Studies have found that online nutrition education significantly lowers the risk of poor nutrition in preschool children. For example, one study found a significant drop in high-risk cases after parents took online nutrition classes. Another study highlights that programs focused on parents can encourage healthy eating habits in children. Overall, this evidence suggests that the StEP OUT program could help young children develop healthier weight habits by educating their parents.678910
Are You a Good Fit for This Trial?
This trial is for Latino families expecting a baby or with an infant, aiming to prevent early child obesity. Participants will be taught healthy habits through an online program. They must be willing to engage in group text chats, video calls, and respond to surveys if assigned to StEP OUT; or receive texts with tips if in the control group.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the StEP OUT program or Infant Safety Education. StEP OUT includes group text chats and video calls, while Infant Safety Education involves periodic text messages with helpful links and tips.
Follow-up
Participants are monitored for feasibility and acceptability of the intervention, including recruitment, retention, and fidelity metrics.
What Are the Treatments Tested in This Trial?
Interventions
- StEP OUT
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwell Health
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator