Teen Mom Study Feasibility Trial

May 13, 2025 updated by: University of Mississippi Medical Center

Teen Mom Study Feasibility Trial: A Multicomponent Digital Health Intervention to Improve Cardiometabolic Health in Pregnant Black Adolescents

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Teen Mom 2 will assess the feasibility, acceptability, and early efficacy of a 20-week multilevel, multicomponent digital health intervention, Mama Let's Move, delivered through the University of Mississippi Medical Center's Telehealth Center for Excellence in partnership with the Special Supplemental Nutritional Program for Women, Infants, and Children (WIC) to increase physical activity (PA) and reduce sedentary behavior (SB) in pregnant, Black adolescent WIC clients in the Mississippi Delta. The Social Ecological Model and TElehealth in CHronic Disease Model provide an empirical framework for considering multiple determinants of health behavior and evaluating mechanisms of implementation and intervention impacts. At the person level, pregnant, Black adolescent (15- to 19-years) WIC clients (n=20) will be given three empirically supported behavior goals to (1) watch 2 hours or less of television per day, (2) take 10,000 steps or more per day, and (3) engage in 20 minutes or more of organized exercise like prenatal yoga or dance videos per day. The intervention is designed to build social cognition, affect, and skills using four intervention components including a Fitbit activity tracker, interactive self-monitoring text messages with tailored feedback, tailored skills training text messages and materials, and peer health coaching. At the systems-level, racially concordant young adult (20- to 25-years) WIC moms (n=8) will be hired and trained to deliver peer health coaching in a telehealth setting to first, address social needs and second, to provide support for achieving the three behavior goals. The specific aims are to: (1) assess the impact of Mama Let's Move on objectively measured light-to-moderate PA and SB from baseline (<20-weeks' gestation) to 26- and 36-weeks' gestation in pregnant, Black adolescents; (2) use remote patient monitoring to objectively measure and characterize patterns of weight gain from baseline to 26- and 36-weeks' gestation; and (3) evaluate the feasibility and acceptability of training young adult WIC moms to provide health coaching in a telehealth setting. This study will advance public health and scientific knowledge in preparation for a future cluster randomized clinical trial by: training WIC moms to provide health coaching to pregnant, Black adolescents in a telehealth setting; developing an attention-control arm; assessing changes in adolescents' PA and SB throughout pregnancy in response to a 20-week intervention; characterizing patterns of weight gain throughout pregnancy in Black adolescents; comparing adolescents across counties and WIC providers; and evaluating an implementation partnership between WIC and the Telehealth Center of Excellence.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Abigail Gamble, PhD, MS
  • Phone Number: 601-815-9065
  • Email: agamble2@umc.edu

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Abigail Gamble, PhD
      • Jackson, Mississippi, United States, 39216
        • Not yet recruiting
        • University of Mississippi Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: #BabyLetsMove
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Perceptions of acceptability at 36 weeks' gestation (post-intervention)
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.
Perceptions of appropriateness at study month 30 (of 36 months).
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.
Average number of coaching sessions completed at 20 weeks (post-intervention)
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.
Average length in minutes of coaching sessions at 20 weeks (post-intervention)
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.
Average number of text message responses at 20 weeks (post-intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Moderate-to-vigorous physical activity (MVPA)
Time Frame: Change in MVPA from baseline (< 16 weeks' gestation) to 26 weeks' gestation.
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.
Change in MVPA from baseline (< 16 weeks' gestation) to 26 weeks' gestation.
Sedentary behavior (SB)
Time Frame: Change in SB from baseline (< 16 weeks' gestation) to 26 weeks' gestation.
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.
Change in SB from baseline (< 16 weeks' gestation) to 26 weeks' gestation.
Moderate-to-vigorous physical activity (MVPA)
Time Frame: Change in MVPA from baseline (< 16 weeks' gestation) to 36 weeks' gestation.
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.
Change in MVPA from baseline (< 16 weeks' gestation) to 36 weeks' gestation.
Sedentary behavior (SB)
Time Frame: Change in SB from baseline (< 16 weeks' gestation) to 36 weeks' gestation.
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.
Change in SB from baseline (< 16 weeks' gestation) to 36 weeks' gestation.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean arterial pressure
Time Frame: Change in mean arterial pressure from baseline (< 16 weeks' gestation) to 26 weeks' gestation.
Ambulatory BP will be measured over 24 hours using Spacelabs OnTrak monitor. Data will be summarized to derive mean arterial pressure (MAP) by 24 hours and nighttime.
Change in mean arterial pressure from baseline (< 16 weeks' gestation) to 26 weeks' gestation.
Mean arterial pressure
Time Frame: Change in mean arterial pressure from baseline (< 16 weeks' gestation) to 36 weeks' gestation.
Ambulatory BP will be measured over 24 hours using Spacelabs OnTrak monitor. Data will be summarized to derive mean arterial pressure (MAP) by 24 hours and nighttime.
Change in mean arterial pressure from baseline (< 16 weeks' gestation) to 36 weeks' gestation.
Glucose variability
Time Frame: Change in glucose variability from baseline (< 16 weeks' gestation) to 26 weeks' gestation.
Continuous glucose will be measured over 3 days using a wearable device on the back of the participants' dominant arm.
Change in glucose variability from baseline (< 16 weeks' gestation) to 26 weeks' gestation.
Glucose variability
Time Frame: Change in glucose variability from baseline (< 16 weeks' gestation) to 36 weeks' gestation.
Continuous glucose will be measured over 3 days using a wearable device on the back of the participants' dominant arm.
Change in glucose variability from baseline (< 16 weeks' gestation) to 36 weeks' gestation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Mississippi Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Minority Health and Health Disparities (NIMHD)
National Institute of General Medical Sciences (NIGMS)
Health Resources and Services Administration (HRSA)
Mississippi State Department of Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Abigail Gamble, PhD, MS, University of Mississippi Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 7, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-110
  • U54GM115428 (U.S. NIH Grant/Contract)
  • P50MD017338 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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