Activity Intervention for Pregnancy Stress
(STEP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a personalized smartphone-based activity plan, called "Activity Intervention," can reduce stress in pregnant women at high risk for pregnancy complications. Participants will use a wrist-based activity tracker to monitor physical activity and sleep. The trial compares usual care with additional guidance on exercise and sleep. Ideal candidates are pregnant women who feel stressed, have a BMI of 30 or more, or have experienced complications like preeclampsia or preterm birth in previous pregnancies. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance stress management for pregnant women.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this activity intervention is safe for pregnant women?
Research has shown that being active during pregnancy can reduce stress and improve mental health. Studies have found that staying active lowers the risk of prenatal depression by 32% and anxiety by 33%. Techniques such as yoga and mindfulness also reduce stress in pregnant women.
In this trial, participants will wear a wrist-based activity tracker and receive detailed information about their physical activity and sleep. These methods are typically easy to use and present no major safety concerns. The trial focuses on encouraging healthy habits, which are generally safe and beneficial for both mother and baby.12345Why are researchers excited about this trial?
Researchers are excited about the Activity Intervention for pregnancy stress because it focuses on non-medical, lifestyle-based strategies that could improve mental health during pregnancy. Unlike medication or therapy, which are common treatments for stress and anxiety during pregnancy, this approach emphasizes the benefits of physical activity and sleep. The intervention is unique as it includes detailed information and reminders, potentially making it more engaging and sustainable for expectant mothers. By promoting healthier habits, this method might offer a more holistic way to manage stress without the need for pharmaceuticals.
What evidence suggests that this activity intervention is effective for reducing pregnancy stress?
Research shows that stress during pregnancy can harm both the mother's health and the baby's development. Studies have found that relaxation techniques can lower stress and improve mental health for pregnant women. One study reported a significant decrease in stress levels, while another found that these techniques also reduced symptoms of depression. In this trial, participants in the Activity Intervention group will receive personalized advice on exercise and sleep, which might help lower stress in high-risk pregnancies, similar to benefits observed in other relaxation-focused studies.12678
Who Is on the Research Team?
Tracy Manuck, MD
Principal Investigator
University of North Carolina, Chapel Hill
Are You a Good Fit for This Trial?
This trial is for pregnant women at high risk of complications due to obesity or past issues like preeclampsia, with a stress score ≥14. They must be 8-19.9 weeks along in a single pregnancy without abnormalities, aged 18-51, speak English, and own a compatible smartphone.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Enrollment and Baseline Assessment
Participants complete dietary, stress, sleep, and body image questionnaires and provide initial biological samples
Intervention
Participants receive a wrist-based activity tracker and are randomized to either receive personalized counseling with weekly text messages or standard care
Follow-up
Participants are monitored for maternal and neonatal outcomes, with biological samples collected at delivery
What Are the Treatments Tested in This Trial?
Interventions
- Activity Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor