Teen Mom Study: A Confirmatory Pragmatic Cluster RCT
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15-19
SponsorUniversity of Mississippi Medical Center
About this 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?
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Less than 16 weeks pregnant
Black or African-American
Between 15 and 19 years of age (inclusive)
Enrolled in WIC
Disqualifiers
Individuals with physical activity restrictions
Trial design
Design model
Parallel
Treatments tested in this trial
#BabyLetsMove
BehavioralDescription of #BabyLetsMove
WIC Antenatal Care
BehavioralDescription
Treatment groups
144 Participants
are divided into 2 treatment groupsGroup A: #BabyLetsMoveExperimental treatment 1 intervention
Group B: WIC Antenatal CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to 26 weeks gestation2
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.
Time frame
Baseline to 36 weeks gestation3
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.
Time frame
Baseline to 26 weeks gestation4
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.
Time frame
Baseline to 36 weeks gestationSecondary outcomes
1
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.
Time frame
Baseline to 26 weeks gestation2
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.
Time frame
Baseline to 36 weeks gestation3
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.
Time frame
Baseline to 26 Weeks Gestation4
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.
Time frame
Baseline to 36 Weeks GestationLocations
Sponsors and contacts
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University of Mississippi Medical Center
Lead sponsor
University of Alabama at Birmingham
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov
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