Sedentary BehaviorNCT06216925
Teen Mom Study: A Confirmatory Pragmatic Cluster RCT
A study testing #BabyLetsMove and WIC Antenatal Care in people with Sedentary Behavior and Physical Activity, run by University of Mississippi Medical Center.
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… Read more about this study
- Who is it for?
- Ages 15 to 19 years, women only
- Conditions the study is for
- Sedentary Behavior, Physical Activity, Gestational Weight Gain
- What is being tested?
- #BabyLetsMove and WIC Antenatal Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- Planning to carry the fetus to term
- English speaking
- Possession of a mobile device
Who cannot join
- Individuals with physical activity restrictions
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Teen Mom Study: A Confirmatory Pragmatic Cluster Randomized Controlled Trial
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?
Read more
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.
Read the detailed 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.
- Being tested
- #BabyLetsMove, WIC Antenatal Care
- Keywords
- Pregnancy, Adolescent, Mobile Health
- Medical subject headings
- Sedentary Behavior, Motor Activity, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
#BabyLetsMoveBehavioural
Description of #BabyLetsMove
WIC Antenatal CareBehavioural
Description
| Study group | Role | What they receive |
|---|---|---|
| #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. Receives: 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. Receives: Behavioral: WIC Antenatal Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 36 weeks gestation
Secondary outcomes (4)
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.
Measured: Baseline to 26 weeks gestation
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.
Measured: Baseline to 36 weeks gestation
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.
Measured: Baseline to 26 Weeks Gestation
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.
Measured: Baseline to 36 Weeks Gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Aug 2025 (estimated)
- Primary completion19 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Abigail Gamble, University of Mississippi Medical Center
- Investigators
- Abigail Gamble, PhD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216925
- Sponsor's protocol ID
- 2023-409
- Other IDs
- P50MD017338
- Status last verified
- Apr 2025
- First submitted
- 11 Jan 2024
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teen Mom Study: A Confirmatory Pragmatic Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06216925
- Acronym / sponsor ID
- 2023-409
- Keywords
- Pregnancy, Adolescent, Mobile Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 19 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| #BabyLetsMove | Experimental | Behavioral: #BabyLetsMoveFor 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. |
| WIC Antenatal Care | Active comparator | Behavioral: WIC Antenatal CareThe participants will receive ancillary healthy food to allay food insecurity, nutritional counseling, and clinical care referrals once every three months. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- Individuals with physical activity restrictions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| #BabyLetsMoveDescription of #BabyLetsMove | Behavioural | #BabyLetsMove |
| WIC Antenatal CareDescription | Behavioural | WIC Antenatal Care |
Primary outcome
Change in Moderate-to-Vigorous Physical Activity at 26 Weeks Gestation
Time frame: Baseline to 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.
Change in Moderate-to-Vigorous Physical Activity at 36 Weeks Gestation
Time frame: Baseline to 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.
Change in Sedentary Behavior at 26 Weeks Gestation
Time frame: Baseline to 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.
Change in Sedentary Behavior at 36 Weeks Gestation
Time frame: Baseline to 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.
4 secondary outcomes
Change in Gestational Weight Gain at 26 Weeks Gestation
Time frame: Baseline to 26 weeks gestation
Change in Gestational Weight Gain at 36 Weeks Gestation
Time frame: Baseline to 36 weeks gestation
Change in Mean Arterial Pressure at 26 Weeks Gestation
Time frame: Baseline to 26 Weeks Gestation
Change in Mean Arterial Pressure at 36 Weeks Gestation
Time frame: Baseline to 36 Weeks Gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abigail Gamble, PhD principal investigator
University of Mississippi Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing #BabyLetsMove and WIC Antenatal Care in people with Sedentary Behavior and Physical Activity, run by University of Mississippi Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abigail Gamble, PhD (601-815-9482, agamble2@umc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Moderate-to-Vigorous Physical Activity at 26 Weeks Gestation (time frame: Baseline to 26 weeks gestation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.