Teen Mom Study Feasibility Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15-19
SponsorUniversity of Mississippi Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
15- to 19-years
Black or African American
<20 weeks' gestation
Enrolled in WIC
Disqualifiers
Restrictions on physical activity or exercise
Trial design
Design model
Single group
Treatments tested in this trial
#BabyLetsMove
BehavioralThe #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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: #BabyLetsMoveExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acceptability
Qualitative interviews will be conducted with teens (n=20) to explore their satisfaction with the intervention components.
Time frame
Perceptions of acceptability at 36 weeks' gestation (post-intervention)2
Appropriateness
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.
Time frame
Perceptions of appropriateness at study month 30 (of 36 months).3
Intensity coaching session number
The intervention intensity will be determined based on the number of coaching sessions.
Time frame
Average number of coaching sessions completed at 20 weeks (post-intervention)4
Intensity coaching session length
The intervention intensity will be determined based on the length in minutes of coaching sessions.
Time frame
Average length in minutes of coaching sessions at 20 weeks (post-intervention)Secondary outcomes
1
Moderate-to-vigorous physical activity (MVPA)
GT9X ActiGraph accelerometer. Accelerometers will be worn on participants' non-dominant wrist for 7-days, 24-hours per day to record raw acceleration data using a sampling rate of 100 Hz that will be converted into objective measures. Counts: moderate (1952 - 5724 counts per minute) and vigorous (\>5724 counts per minute) PA. Wear-time compliance will include 20 hours per day, \> 4 days per week including 1 weekend day.
Time frame
Change in MVPA from baseline (< 16 weeks' gestation) to 26 weeks' gestation.2
Sedentary behavior (SB)
GT9X ActiGraph accelerometer. Accelerometers will be worn on participants' non-dominant wrist for 7-days, 24-hours per day to record raw acceleration data using a sampling rate of 100 Hz that will be converted into objective measures. Counts: SB (\<100 counts per minute). Wear-time compliance will include 20 hours per day, \> 4 days per week including 1 weekend day.
Time frame
Change in SB from baseline (< 16 weeks' gestation) to 26 weeks' gestation.3
Moderate-to-vigorous physical activity (MVPA)
GT9X ActiGraph accelerometer. Accelerometers will be worn on participants' non-dominant wrist for 7-days, 24-hours per day to record raw acceleration data using a sampling rate of 100 Hz that will be converted into objective measures. Counts: moderate (1952 - 5724 counts per minute) and vigorous (\>5724 counts per minute) PA. Wear-time compliance will include 20 hours per day, \> 4 days per week including 1 weekend day.
Time frame
Change in MVPA from baseline (< 16 weeks' gestation) to 36 weeks' gestation.4
Sedentary behavior (SB)
GT9X ActiGraph accelerometer. Accelerometers will be worn on participants' non-dominant wrist for 7-days, 24-hours per day to record raw acceleration data using a sampling rate of 100 Hz that will be converted into objective measures. Counts: SB (\<100 counts per minute). Wear-time compliance will include 20 hours per day, \> 4 days per week including 1 weekend day.
Time frame
Change in SB from baseline (< 16 weeks' gestation) to 36 weeks' gestation.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Mississippi Medical Center
Lead sponsor
Mississippi State Department of Health
Collaborator
Health Resources and Services Administration (HRSA)
Collaborator
National Institute of General Medical Sciences (NIGMS)
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov