Family Based Time-Restricted Eating
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      This study will test whether managing the hours during which people eat, called time
      restricted eating, might help them to lose weight. For this study, one parent and a child
      will enroll as a group (called a dyad).

      The dyads will be assigned at random to practice time restricted eating (within 10-12 hours
      per day) but will be able to eat whatever they would like or to limit portion size and
      increase fruit, vegetable and lean protein intake and limit sugar sweetened beverages and
      undergo . Both groups will receive dietary counseling, Bluetooth toothbrushes and scales to
      help monitor their progress.

      The study will last for 12 weeks and will have one survey four weeks after the last in person
      visit. There will be 2 in person visits, 7 virtual visits, 2 phone visits and daily time
      logs.
    

Detailed description: 
      This study will provide preliminary data to demonstrate feasibility and acceptability of
      time-restricted eating (TRE) in the family unit, providing critical preliminary data to
      support NIH-level funding for a more detailed analysis of TRE in families.

      Obesity affects over 40% of adults and over 25% of children in the United States. Obesity -
      defined in adults as a body mass index (BMI) > 30 kg/m2 and in children as BMI > 95th
      percentile - is associated with several physical and psychological comorbidities, such as
      hypertension, heart disease, type 2 diabetes mellitus, and reduced quality of life.
      Heritability of obesity is 40-75%. Thus, if a parent is obese, children in the family have a
      high likelihood of also becoming obese due to both genetic and environmental factors. As
      such, treatments that apply to the family unit can address the public health concern of
      obesity at the child and adult level.

      Typically, obesity treatment primarily focuses on intentional caloric restriction. In adults
      with obesity, behavior-based weight loss programs result in weight reduction of 1-4 kg over
      one year. In children with obesity, lifestyle modification therapy typically results in
      weight stabilization, while children without treatment gain weight. Weight stabilization
      results in reductions in body mass index parameters (e.g., percent BMI or BMI z-score) due to
      increased height in children. Family-based obesity treatment also focuses on intentional
      caloric restriction through reduced consumption of energy dense foods, as well as increased
      consumption of low energy density foods, increased physical activity, and implementation of
      strategic parenting practices. Parent BMI change is a significant predictor of child outcomes
      in family-based treatment. Unfortunately, family-based interventions are typically time and
      resource intensive, thus limiting their receptiveness by many families.

      In contrast to intentionally restricting calories, time-restricted eating (TRE) intentionally
      restricts the eating window while allowing ad libitum intake during the window. TRE's
      agnostic approach to eating allows individuals to select foods that align with their needs
      and preferences. Multiple studies in adults, including our own, demonstrate TRE reduces
      weight. The postulated mechanism is that a reduced eating window reduces the number of eating
      occasions to reduce daily caloric intake.
    

Intervention name(s): TRE Group
Intervention type(s): Behavioral
Intervention description(s): This group will practice time-restricted eating
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 20 dyads will be enrolled in this study. A dyad will consist of a parent and a child. Dyads will be randomized to one of two treatment groups: the time restricted eating (TRE) group or standard of care control group.
Masking: None (Open Label)
Primary purpose: Treatment