#BabyLetsMove Physical Activity Feasibility Trial
Condition: Pregnancy Related; Adolescent Obesity; Behavior, Health; Behavior, Sedentary; Adolescent Overweight; Mobile Phone Use; Pregnancy in Adolescence
MeSH terms: Obesity; Overweight; Pediatric Obesity
Study type: Interventional

Summary: 
      Black adolescents who are pregnant represent a high-risk and understudied perinatal
      population in health research. Adolescent pregnancy (<20 years) is disproportionately
      prevalent among Blacks compared with Whites and is a prominent risk factor for obesity.
      Fortunately, metabolic consequences of increasing physical activity coupled with minimal
      sedentary time can mitigate biological imperils and behavioral interventions targeting
      perinatal populations have demonstrated efficacy for this approach. Intervention studies to
      promote physical activity and reduce sedentarism among Black, perinatal adolescents in
      disadvantaged, rural settings may be a promising strategy to prevent obesity and reduce
      disparities. In the proposed study, investigators will assess the feasibility and
      acceptability of #BabyLetsMove, a mobile health intervention targeting three behavioral
      goals: (1) limit TV time to less than 2 hours a day (sedentary behavior); (2) take 10,000
      steps or more per day (physical activity); and (3) do 20 minutes or more of structured
      activity like prenatal yoga or dance videos per day (exercise). In the #BabyLetsMove
      feasibility trial investigators aim to conduct a single-arm, 4-week pilot with 20 Black
      adolescents (15- to 19-years) enrolled in Mississippi's Supplemental Nutritional Program for
      Women, Infants and Children (WIC) to test the intervention's feasibility and acceptability.
      Participants will receive one text message per day for 4-weeks targeting behavior change
      strategies and two health coaching sessions via mobile phone; an introduction session in week
      one and a problem-solving session in week three. Investigators will also use qualitative
      interviewing with additional adolescents (n=20) to solicit user feedback regarding the
      acceptability of intervention content and materials. Finally, in preparation for a pilot
      study using an effectiveness-implementation hybrid study design, investigators will conduct a
      pre-implementation evaluation using quantitative surveying (n=6 surveys) with WIC providers
      (n=60) to better under the culture and climate of WIC. Investigators hypothesize the
      #BabyLetsMove intervention will be acceptable to adolescents and a future pilot randomized
      controlled trial will be feasible. Investigators also anticipate identifying modifiable
      barriers and facilitators to implementing the intervention through WIC, which will help to
      design an implementation strategy with a high likelihood for uptake by WIC.
    

Detailed description: 
      Formative research is needed to establish a foundation for obesity prevention research with
      high-risk, disadvantaged, perinatal adolescents and their offspring. In particular, Black
      pregnant adolescents in socioeconomically disadvantaged communities represent a high-risk and
      understudied perinatal population in health research. Adolescent pregnancy (<20 years) is
      disproportionately prevalent among Blacks compared with Whites (27.6 and 13.4 per 1,000,
      respectively) and is a prominent risk factor for obesity. Normal pubertal growth is
      associated with increased weight in adolescence and Black female and rural adolescents are at
      highest risk for excessive adiposity. Pregnancy exacerbates preexisting risks and predicates
      a trajectory of maternal and child obesity. Fortunately, metabolic consequences of increasing
      physical activity coupled with minimal sedentary behavior can mitigate biological imperils
      and behavioral interventions targeting perinatal populations have demonstrated efficacy for
      this approach. Intervention studies to promote physical activity and reduce sedentary
      behavior among Black, perinatal adolescents in disadvantaged, rural settings may be a
      promising strategy to prevent obesity and reduce disparities. To this end, investigators
      conducted formative work in the Teen Mom Study, an exploratory investigation to identify
      modifiable psychosocial, cultural and environmental determinants of physical activity among
      pregnant and postpartum adolescents enrolled in Mississippi's Supplemental Nutritional
      Program for Women Infants and Children (WIC) in the Mississippi Delta. WIC is a
      federally-funded, state-run public health service providing healthy food and nutrition
      counseling to low-income women, infants and children at nutritional risk. Public health
      services like WIC are ideal settings for the prevention and treatment of obesity among
      high-risk, socioeconomically disadvantaged populations. The Mississippi Delta is a culturally
      and geographically distinct 18-county rural region of Mississippi that is plagued by decades
      of persistent poverty, poor health and the highest teen birth rate, which has not declined
      since 2006, in the United States. Using data from the Teen Mom Study, investigators adapted
      an existing mobile health (mHealth) intervention to achieve three behavioral goals: (1) limit
      TV time to less than 2 hours a day (sedentary behavior); (2) take 10,000 steps or more per
      day (physical activity; tracked using a FitBit provided to each study participant); and (3)
      do 20 minutes or more of structured activity like prenatal yoga or dance videos per day
      (exercise). In the #BabyLetsMove feasibility trial investigators aim to conduct a single-arm,
      4-week pilot with 20 overweight or obese, Black, pregnant (<16 weeks) adolescent (15 - 19
      years) WIC clients to test the feasibility and acceptability of the intervention.
      Participants will receive text messages aligned with theoretical behavior change strategies
      every day of the week for 4-weeks including: 1) four skills texts, which may be a simple text
      or a text with a link to either a PDF or video; 2) two goal monitoring text messages, which
      will check-in on the three behavior change goals; and 3) and one text message for
      participants to report their weight using a BodyTrace scale provided by the study. Text
      messages will be supplemented with two health coaching telephone calls conducted by the
      principal investigator; an introduction session in the first week, followed by a
      problem-solving session in week three. While the study goal is to assess feasibility and
      acceptability, physical activity assessed using accelerometry, subjective psychosocial
      constructs, and anthropometric and biomarker measures will be measured at pre- (week 1) and
      post- (week 6) intervention. To gain additional insight, investigators will use qualitative
      interviewing with additional adolescents (n=20) to solicit user feedback regarding the
      acceptability of intervention content (text messages) and materials (PDFs and videos).
      Finally, in preparation for a randomized pilot trial using an effectiveness-implementation
      hybrid research design, investigators will conduct a pre-implementation evaluation using
      quantitative surveying (n=6 surveys) with WIC providers (n=60) to better under the context,
      culture and climate of WIC (implementation measures identified in the Consolidated Framework
      for Implementation Research). Investigators hypothesize the #BabyLetsMove intervention
      materials will be acceptable to adolescents and that conducting a future pilot randomized
      controlled trial will be feasible. Investigators also anticipate identifying modifiable
      barriers and facilitators to implementing the intervention through WIC, which will help to
      design an implementation strategy with a high likelihood for uptake by WIC. If proven to be
      effective, #BabyLetsMove mHealth intervention may be a scalable approach to increase physical
      activity among socioeconomically disadvantaged adolescents at high risk for maternal and
      child obesity.
    

Intervention name(s): #BabyLetsMove
Intervention type(s): Behavioral
Intervention description(s): This intervention will use mobile phones to promote the adoption and maintenance of physical activity, exercise and reduced TV time among overweight or obese, Black, pregnant (<16 weeks) adolescents (15 - 19 years) enrolled in Mississippi's WIC program.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pregnancy in adolescence; Exercise; Physical activity; Sedentary behavior; mHealth; Obesity in pregnancy; Adolescent obesity; Adolescent overweight; Behavioral science; Implementation science; Clinical trial