NCT05843903 · University of Mississippi Medical Center
Teen Mom Study Feasibility Trial
What this study is about
The proposed multicomponent digital health intervention has the potential to significantly impact the trajectory of maternal health in a rural, pregnant, Black adolescent population with the highest risks for cardiometabolic diseases worldwide.
View original scientific description
The proposed multicomponent digital health intervention has the potential to significantly impact the trajectory of maternal health in a rural, pregnant, Black adolescent population with the highest risks for cardiometabolic diseases worldwide. The proposed implementation strategy leverages mobile technologies which are ubiquitous across the socioeconomic gradient and proposes to train young adult WIC moms to deliver peer health coaching in a telehealth setting to address social barriers and support behavior change in pregnant, Black adolescent WIC clients in the Mississippi Delta - a rural region where the population is more than two-thirds percent Black and the teen birth rate is the highest in the United States. This is a scalable and sustainable approach to enhance WIC services and improve WIC's impact on population health and cardiometabolic health disparities in Black women.
Interventions
BEHAVIORAL
#BabyLetsMove
The #BabyLetsMove digital health intervention uses a multi-level, systems-change approach. At the systems-level, racially concordant young adult WIC moms will be trained as health coaches. At the person level, adolescent WIC clients will be given empirically supported behavior goals, self-monitoring text messages with automated feedback, tailored skills training materials, a FitBit device, and tailored peer coaching support. The #BabyLetsMove intervention design is based on formative Teen Mom Study findings to build social cognition, affect, and skills to modify 3 concrete, achievable, and easily monitored behavioral targets: (1) Limit television viewing time to less than 2 hours per day; (2) Walk at least 10,000 steps per day; and (3) Do 20 minutes or more of exercise per day.
Primary outcome measures
Acceptability
Time frame: Perceptions of acceptability at 36 weeks' gestation (post-intervention)
Qualitative interviews will be conducted with teens (n=20) to explore their satisfaction with the intervention components.
Appropriateness
Time frame: Perceptions of appropriateness at study month 30 (of 36 months).
Qualitative interviews will be conducted with peer health coaches (n=2) about their experience delivering coaching, case management support, and satisfaction with their role as a coach. Interviews with WIC leaders (n=3) and local WIC providers (n=5) will explore opinions on delivering coaching in a telehealth setting to enhance WIC's capacity to serve rural communities.
Intensity coaching session number
Time frame: Average number of coaching sessions completed at 20 weeks (post-intervention)
The intervention intensity will be determined based on the number of coaching sessions.
Intensity coaching session length
Time frame: Average length in minutes of coaching sessions at 20 weeks (post-intervention)
The intervention intensity will be determined based on the length in minutes of coaching sessions.
Intensity text message response number
Time frame: Average number of text message responses at 20 weeks (post-intervention)
The intervention intensity will be determined based on the number of responses to interactive text messages.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 15- to 19-years
- Black or African American
- \<20 weeks' gestation
- Enrolled in WIC
- Residing in 1 of 8 Mississippi Delta Counties
- English speaking
- Own or have personal use of a mobile smart phone
- Singleton pregnancy
- Plan to carry the fetus to term and keep the infant after birth
- No history of chronic medical conditions in the past year that could influence weight loss or gain
Exclusion criteria
- Restrictions on physical activity or exercise
Where
- Jackson, Mississippi
Collaborators
Mississippi State Department of Health, Health Resources and Services Administration (HRSA), National Institute of General Medical Sciences (NIGMS), National Institute on Minority Health and Health Disparities (NIMHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 15, 2025 · Source of record for eligibility and locations