Teen Mom Study: A Confirmatory Pragmatic Cluster RCT

Physical Activity Clinical Trial

Official title:

Teen Mom Study: A Confirmatory Pragmatic Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06216925
• Other study ID #: 2023-409
• Secondary ID: P50MD017338
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: June 5, 2026

Study information

• Verified date: April 2024
• Source: University of Mississippi Medical Center
• Contact: Abigail Gamble, PhD
• Phone: 601-815-9482
• Email: agamble2[@]umc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to test the effectiveness of #BabyLetsMove - a 24-week mobile Health and peer health coaching intervention paired with the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) - to increase physical activity and reduce sedentary behavior in pregnant, Black teens in the Mississippi Delta. The main questions it aims to answer are: - Does #BabyLetsMove increase objective moderate-to-vigorous physical activity and decrease sedentary behavior from ≤16 to 26- and 36-gestational weeks compared to usual WIC care alone? - Does # BabyLetsMove decrease the rate of gestational weight gain and mean arterial pressure from ≤16 to 26- and 36-gestational weeks compared to usual WIC care alone? - Is #BabyLetsMove a feasible and acceptable intervention according to the RE-AIM framework? - Using the Practical, Robust Implementation and Sustainability Model and the Consolidated Framework for Implementation Research, what are the barriers to organizational uptake and how can strategies be improved for future testing? Participants will be given three empirically supported behavior goals including (1) watching ≤2 hours of TV or other screen time per day, and (2) walking ≥10,000 steps per day - or - (3) engaging in ≥20 minutes of organized exercise per day. Researchers will compare the #BabyLetsMove groups to the WIC care only groups to see if the #BabyLetsMove intervention improves traditional WIC care for bettering health outcomes ( amongst pregnant, Black teens in the Mississippi Delta.

Description:

The "Teen Mom Study: A Hybrid Cluster Randomized Trial" proposes a pragmatic, multilevel, type I study design to test the effectiveness of #BabyLetsMove - a 24-week mHealth and peer health coaching intervention paired with the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) - to increase physical activity and reduce sedentary behavior in pregnant, Black teens in the Mississippi Delta. Concurrently, a robust implementation evaluation will be conducted to determine feasibility and acceptability and to identify threats to organizational uptake, scalability, and sustainability. The intervention will be delivered remotely in partnership with WIC (Mississippi State Department of Health), the Telehealth Center of Excellence, and Myrlie Evers-Williams Institute (University of Mississippi Medical Center). The intervention is based on formative data from the "Teen Mom Study" and uses a theory-based, multi-level systems change approach. At the systems level, racially concordant young adult (18 to 25 years) WIC moms (n=4) are undergoing paid skills training in evidence-based peer health coaching to first, address social needs in pregnant teens and second, provide support for self-directed behavior change. At the individual level, pregnant, Black teens will be given three empirically supported behavior goals including (1) watching ≤2 hours of TV or other screen time per day, and (2) walking ≥10,000 steps per day - or - (3) engaging in ≥20 minutes of organized exercise per day. The intervention is designed to build social cognition, affect, and skills using four intervention components - a wearable tracker, interactive self-monitoring text messages with automated feedback, tailored skills training texts linked to digital materials, and peer health coaching. The central hypothesis is that augmenting usual WIC care with #BabyLetsMove will improve WIC's capacity to serve rural families and empower pregnant, Black teens to prioritize and improve their health. The primary aim is to determine the effect of #BabyLetsMove compared to usual WIC care on objective moderate-to-vigorous physical activity and sedentary behavior from ≤16 to 26- and 36-gestational weeks using a parallel cluster randomized trial. Secondary aim 1 will use wearables plus remote monitoring to measure and explore patterns of gestational weight gain and mean arterial pressure within/across conditions. Secondary aim 2.a. will use the RE-AIM framework to evaluate the feasibility and acceptability of #BabyLetsMove, and Secondary aim 2.b. will use the Practical, Robust Implementation and Sustainability Model and the Consolidated Framework for Implementation Research to identify threats to organizational uptake and to develop implementation strategies for future testing. This is believed to be the first digital health intervention study designed with/for a pregnant adolescent population. This study will add to our understanding of optimal mHealth and peer health coaching interventions; advance implementation science literature by studying a scalable and sustainable intervention in a novel setting; and contribute to the urgent national agenda to advance Black maternal health equity.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: June 5, 2026
• Est. primary completion date: May 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 19 Years

Eligibility

Inclusion Criteria:

• Less than 16 weeks pregnant
• Black or African-American
• Between 15 and 19 years of age (inclusive)
• Enrolled in WIC
• Residing in 1 of 12 counties constituting the Mississippi Delta region
• Singleton pregnancy
• Planning to carry the fetus to term
• English speaking
• Possession of a mobile device

Exclusion Criteria:

• Individuals with physical activity restrictions

Related Conditions & MeSH terms

• Arterial Pressure
• Gestational Weight Gain
• Physical Activity
• Sedentary Behavior
• Weight Gain

Intervention

Behavioral:
• #BabyLetsMove
Description of #BabyLetsMove
• WIC Antenatal Care
Description

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Mississippi Medical Center	National Institute on Minority Health and Health Disparities (NIMHD), University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Moderate-to-Vigorous Physical Activity at 26 Weeks Gestation	Actigraph accelerometry (GT9X Link) will be used to measure MVPA (>3 METs) and SB (<1.5 METs) for 24 hours per day, over a 7-day period,155 across 3-time points (Table 5). Accelerometers will be worn on teens' non-dominant wrists to record raw acceleration data using a sampling rate of 100 Hz and converted into objective measures.	Baseline to 26 weeks gestation
Primary	Change in Moderate-to-Vigorous Physical Activity at 36 Weeks Gestation	Actigraph accelerometry (GT9X Link) will be used to measure MVPA (>3 METs) for 24 hours per day, over a 7-day period. Accelerometers will be worn on teens' non-dominant wrists to record raw acceleration data using a sampling rate of 100 Hz and converted into objective measures.	Baseline to 36 weeks gestation
Primary	Change in Sedentary Behavior at 26 Weeks Gestation	Actigraph accelerometry (GT9X Link) will be used to measure sedentary behavior (<1.5 METs) for 24 hours per day, over a 7-day period. Accelerometers will be worn on teens' non-dominant wrists to record raw acceleration data using a sampling rate of 100 Hz and converted into objective measures.	Baseline to 26 weeks gestation
Primary	Change in Sedentary Behavior at 36 Weeks Gestation	Actigraph accelerometry (GT9X Link) will be used to measure sedentary behavior (<1.5 METs) for 24 hours per day, over a 7-day period. Accelerometers will be worn on teens' non-dominant wrists to record raw acceleration data using a sampling rate of 100 Hz and converted into objective measures.	Baseline to 36 weeks gestation
Secondary	Change in Gestational Weight Gain at 26 Weeks Gestation	Body weight will be measured at each time point using Tanita MC-780U scale to assess gestational weight gain (GWG). Participants will use a BodyTrace scale linked to a secure monitoring system for weekly self-weighing monitored by health coaches. If weight is out of range, a structured coaching call will take place.	Baseline to 26 weeks gestation
Secondary	Change in Gestational Weight Gain at 36 Weeks Gestation	Body weight will be measured at each time point using Tanita MC-780U scale to assess gestational weight gain (GWG). Participants will use a BodyTrace scale linked to a secure monitoring system for weekly self-weighing monitored by health coaches. If weight is out of range, a structured coaching call will take place.	Baseline to 36 weeks gestation
Secondary	Change in Mean Arterial Pressure at 26 Weeks Gestation	Ambulatory monitoring negates the low sensitivity and specificity of clinical BP and could detect elevated BP, which is known to lead to pre-eclampsia. Data will be summarized to derive mean arterial pressure (MAP) by 24 hours and night time.	Baseline to 26 Weeks Gestation
Secondary	Change in Mean Arterial Pressure at 36 Weeks Gestation	Ambulatory monitoring negates the low sensitivity and specificity of clinical BP and could detect elevated BP, which is known to lead to pre-eclampsia. Data will be summarized to derive mean arterial pressure (MAP) by 24 hours and night time.	Baseline to 36 Weeks Gestation