Teen Mom Study: A Confirmatory Pragmatic Cluster RCT

NCT06216925 | Not Yet Recruiting

• 2 other identifiers: 2023-409P50MD017338
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

Pregnancy; Adolescent; Mobile Health

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• Change in Gestational Weight Gain at 26 Weeks Gestation

  Baseline to 26 weeks gestation

• Change in Gestational Weight Gain at 36 Weeks Gestation

  Baseline to 36 weeks gestation

• Change in Mean Arterial Pressure at 26 Weeks Gestation

  Baseline to 26 Weeks Gestation

• Change in Mean Arterial Pressure at 36 Weeks Gestation

  Baseline to 36 Weeks Gestation

Study Arms (2)

#BabyLetsMove

EXPERIMENTAL

For 24 weeks, participants will wear a Fitbit activity tracker (continually) and receive interactive self-monitoring and tailored feedback text messages (twice per week), tailored skills training texts and materials (once per week), and peer health coaching (once every other week). In addition, the participants will receive ancillary healthy food to allay food insecurity, nutritional counseling, and clinical care referrals once every three months.

Behavioral: #BabyLetsMove

WIC Antenatal Care

ACTIVE COMPARATOR

The participants will receive ancillary healthy food to allay food insecurity, nutritional counseling, and clinical care referrals once every three months.

Behavioral: WIC Antenatal Care

Interventions

#BabyLetsMove BEHAVIORAL

Description of #BabyLetsMove

#BabyLetsMove

WIC Antenatal Care BEHAVIORAL

Description

WIC Antenatal Care

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Individuals with physical activity restrictions

Sponsors & Collaborators

• University of Mississippi Medical Center: lead
• University of Alabama at Birmingham: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity; Gestational Weight Gain

Condition Hierarchy (Ancestors)

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

Study Officials

• Abigail Gamble, PhD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abigail Gamble, PhD

CONTACT

601-815-9482; agamble2@umc.edu

Rolanda Buck, MS

CONTACT

601-815-9003; rbuck@umc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: August 1, 2025
• Primary Completion: December 19, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share