A Theory Driven, Rurally Tailored, Family-Based, Telehealth Intervention for Childhood Obesity
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      This pilot trial aims to improve the lives of individuals in rural Indiana by addressing the
      leading cause of death, obesity. The purpose is to help children and their families develop
      healthy behaviors to decrease childhood obesity. The short-term goal of this study to develop
      a prototype of theory-driven, tailored, family-based, telehealth intervention that can
      sustainably reduce pediatric obesity rates in rural areas. The long-term goal of this study
      is to sustainably reduce the rates of pediatric obesity and its consequences in rural areas,
      via behavioral change. It is hypothesized that after participating in this intervention,
      children will show improvement in age-based body mass index percentile and improved
      behavioral indicators related to nutrition, physical activity, sleep, and sedentary
      behaviors. Additionally, it is hypothesized that parents will show improved attitudes and
      skills for managing their child's behavior and improved perceived stress and perceived
      quality of life. Finally, levels of attendance, participation, and technology feasibility
      will indicate a successful intervention.
    

Detailed description: 
      This study will utilize a purposive (non-random) sampling strategy. Children belonging to a
      family headed by a parent/guardian will be identified local healthcare providers practicing
      in any rural Indiana counties. The sampling frame will be based on the list of pediatric
      patients who meet eligibility criteria who currently receive services from the rural
      pediatric practices. Members of the research team will not have access to any medical
      records. Identification of the universe of eligible participants is at the sole discretion of
      the healthcare provider.

      This study has a set of primary and secondary objectives for children and their
      parents/guardians, and a separate set of hypotheses for the feasibility of intervention
      delivery. The short-term goal is to develop a prototype for a theory-driven, tailored,
      family-based, telehealth intervention that can sustainably reduce pediatric obesity rates in
      rural areas. The long-term goal is to sustainably reduce pediatric obesity and its
      consequences in rural areas, solely via behavioral change.

      The primary objectives for children are to improve children's behavioral indicators in terms
      of nutrition, physical activity, sleep, and sedentary behaviors, measured both objectively
      and subjectively and sustain them over time. In the end of phase-1 (at crossover point),
      improvement of behavioral indicators related to nutrition, physical activity, sleep, and
      sedentary behaviors among children who were in the intervention group will be superior to
      those in the control group, however, there will be no difference after phase-2 (end of
      study).

      The secondary objective for children is to improve children's body composition, measured with
      the age-sex based BMI percentile. In the end of phase 1, improvement in age-sex based BMI
      percentile among children who were in the intervention group will be superior to those who
      were in the control group; however, there will be no difference after phase 2.

      The primary objectives for parents/guardians are to improve caregivers' attitudes and skills,
      measured as constructs in the Theory of Planned Behavior (i.e., attitudes toward behavior,
      subjective norms, perceived behavioral control, and response efficacy), that are necessary to
      change their child's behaviors. In the end of phase 1, parents/guardians who were in the
      intervention group will show improved attitudes and skills that evidence suggests helps to
      change their child's behaviors, compared to those who were in the control group.

      The secondary objectives for parents/guardians is to improve perceived stress and quality of
      life among parents/guardians. In the end of phase 1, perceived stress and perceived quality
      of life among parents/guardians will be better in the intervention group than the control
      group; however, there will be no difference after phase 2.

      The tertiary objective is to assess the feasibility of the intervention at the end of the
      study for the intervention group only. Intervention will have the levels of attendance and
      participation (i.e., interaction) and technology feasibility (i.e., internet connectivity and
      digital literacy) required for it to be successful.
    

Intervention name(s): Newsletters; Family-based Telehealth Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Similar to prior empirical pediatric obesity interventions (Elder et al., 2009), the active attention waitlist control group will receive monthly newsletters that focus on physical activity, healthy eating, and screen time. These newsletters will be based on standard materials from the We Can program of the National Heart, Lung, and Blood Institute (NHLBI).; All communications related to the intervention will occur through weekly small group video conferencing calls via Zoom and emails or text messages. The intervention will include diverse topics proven effective in prior interventions (Davis et al., 2019; McLean et al., 2003), including reading food labels, eating out, eating at social gatherings, sticker charts, praising/rewarding healthy choices, healthy foods available at home, portion sizes, healthy/easy/low-cost cooking ideas, goal setting, monitoring screen time, exercise opportunities available in neighborhood, family exercise ideas, and healthy sleep. The research team will also send relevant video/audio clips, brochures, reminders (text messages and emails) every week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: childhood obesity; telehealth; family-based