Teen Mom Study Feasibility Trial

NCT05843903 | Recruiting

• 3 other identifiers: 2022-110P50MD017338U54GM115428
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Physical Activity; Sedentary Behavior; Gestational Weight Gain; Social Determinants of Health

Keywords

implementation science; pragmatic clinical trial; telemedicine; health disparity, minority and vulnerable populations; behavior and behavior mechanisms; adolescent pregnancy; black maternal health

Outcome Measures

Primary Outcomes (5)

• Acceptability

  Qualitative interviews will be conducted with teens (n=20) to explore their satisfaction with the intervention components.

  Perceptions of acceptability at 36 weeks' gestation (post-intervention)

• 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.

  Perceptions of appropriateness at study month 30 (of 36 months).

• Intensity coaching session number

  The intervention intensity will be determined based on the number of coaching sessions.

  Average number of coaching sessions completed at 20 weeks (post-intervention)

• Intensity coaching session length

  The intervention intensity will be determined based on the length in minutes of coaching sessions.

  Average length in minutes of coaching sessions at 20 weeks (post-intervention)

• Intensity text message response number

  The intervention intensity will be determined based on the number of responses to interactive text messages.

  Average number of text message responses at 20 weeks (post-intervention)

Secondary Outcomes (4)

• Moderate-to-vigorous physical activity (MVPA)

  Change in MVPA from baseline (< 16 weeks' gestation) to 26 weeks' gestation.

• Sedentary behavior (SB)

  Change in SB from baseline (< 16 weeks' gestation) to 26 weeks' gestation.

• Moderate-to-vigorous physical activity (MVPA)

  Change in MVPA from baseline (< 16 weeks' gestation) to 36 weeks' gestation.

• Sedentary behavior (SB)

  Change in SB from baseline (< 16 weeks' gestation) to 36 weeks' gestation.

Study Arms (1)

#BabyLetsMove

EXPERIMENTAL

There are four digital components to the intervention including Fitbit activity tracker, interactive self-monitoring and tailored feedback text messages, tailored skills training text messages and materials, and peer health coaching.

Behavioral: #BabyLetsMove

Interventions

#BabyLetsMove BEHAVIORAL

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.

#BabyLetsMove

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Restrictions on physical activity or exercise

Sponsors & Collaborators

• University of Mississippi Medical Center: lead
• 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

Study Sites (2)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

NOT YET RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

RECRUITING

Related Publications (3)

• Gamble A, Beech BM, Blackshear C, Herring SJ, Welsch MA, Moore JB. Changes in Physical Activity and Television Viewing From Pre-pregnancy Through Postpartum Among a Socioeconomically Disadvantaged Perinatal Adolescent Population. J Pediatr Adolesc Gynecol. 2021 Dec;34(6):832-838. doi: 10.1016/j.jpag.2021.06.009. Epub 2021 Jul 13.

  PMID: 34271198 BACKGROUND

• Gamble A, Beech BM, Blackshear C, Cranston KL, Herring SJ, Moore JB, Welsch MA. Recruitment planning for clinical trials with a vulnerable perinatal adolescent population using the Clinical Trials Transformative Initiative framework and principles of partner and community engagement. Contemp Clin Trials. 2021 May;104:106363. doi: 10.1016/j.cct.2021.106363. Epub 2021 Mar 15.

  PMID: 33737198 BACKGROUND

• Gamble A, Saulters MM, Cranston KL, Jones DW, Herring SJ, Beech BM. Recruitment, Retention, and Engagement Strategies for Exercise Interventions With Rural Antenatal Adolescents: Qualitative Interviews With WIC Providers. J Public Health Manag Pract. 2020 Sep/Oct;26(5):497-502. doi: 10.1097/PHH.0000000000001027.

  PMID: 32732725 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Sedentary Behavior; Gestational Weight Gain; Behavior

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Abigail Gamble, PhD, MS

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abigail Gamble, PhD, MS

CONTACT

601-815-9065; agamble2@umc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 6, 2023
• Study Start: April 7, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)