Childhood Obesity Microbiome Study
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to measure the effectiveness of a microbiome diet using direct
      food provision on dietary quality and microbiome composition among children with obesity.
      This study proposes a pilot randomized, controlled clinical trial in children of a dietary
      intervention informed by microbiome science.
    

Detailed description: 
      Childhood obesity is a global health crisis and contributes to shortened life expectancy in
      the US, with higher rates and more serious co-morbidities among minorities. Existing dietary
      interventions demonstrate significant heterogeneity of treatment response among diverse
      populations, and clear information to tailor diet to individual-level characteristics is not
      yet available. Recent science suggests that the gut microbiome may in part explain
      inter-individual variation in pediatric obesity and treatment response. Intestinal microbial
      communities play causal roles in models of obesity and are distinct between individuals.
      However, it is unknown how the microbiome mediates response to existing dietary guidelines
      for children with obesity.

      Evidence-based nutritional standards for treatment of pediatric obesity are well-established,
      and aim to reduce body mass index and cardio-metabolic risk. However, these standards have
      not translated into reduced prevalence of obesity among children, particularly those in
      racially diverse and low-income groups. One explanation is the significant inter-individual
      variability in metabolic response to dietary interventions, suggesting that certain food
      components in a diet may benefit some individuals more than others. Another explanation is
      that dietary adherence is highly variable, and requires skills or resources not available to
      all people. For example, translating dietary recommendations into food procurement,
      preparation, and consumption requires baseline levels of educational attainment, child
      acceptability of foods, diet compatibility with cultural preferences, and may be seen as
      time-consuming. These obstacles are hard to overcome for children and families from
      low-income and minority groups, who are known to have low show rates and engagement in
      nutrition studies despite being at disproportionate risk of diseases like obesity and
      metabolic disease. The one-size-fits-all approach to dietary recommendations is failing the
      most vulnerable children in the nation.

      Recent science suggests that the gut microbiome provides new opportunities to address these
      long-standing challenges. Microbiome transplant experiments in mice have demonstrated that
      increased adiposity can be conferred from bacterial communities originating from individuals
      with obesity. Furthermore, variation in microbiome composition between individuals can
      predict response to dietary intervention, suggesting a mechanism for why certain individuals
      lose weight on specific diets and other individuals do not. Another intriguing aspect of
      microbiome science is how its adoption could introduce new methodological techniques to
      obesity treatment. In particular, the plummeting costs and turnaround times of metagenomic
      DNA sequencing used in microbiome research opens new opportunities for rapidly providing
      biomarker information to a wide number of people. |

      No evidence exists that describes microbiome signatures with objective measures of dietary
      quality among children with obesity. The work to be completed here will be a vital first step
      towards integrating the promise of microbiome science into the treatment of pediatric
      obesity. Our team is uniquely suited to take this step as leaders in microbiome science
      (David) and childhood obesity (Armstrong). By working together to predict how individual
      microbiome variation shapes responses to diet therapy, an important step towards
      personalizing dietary recommendations for children based on gut microbiome signatures that
      predict the best outcome will be taken. In addition, linking microbial signatures to measures
      of diet quality will provide researchers with much-needed molecular tools for assessing
      dietary compliance and intervention success. Finally, insights into the impact of receiving
      metagenomic data on children's' motivation towards healthy behaviors could provide behavioral
      and implementation scientists with new tools for improving adherence with obesity treatment
    

Intervention name(s): Microbiome friendly diet
Intervention type(s): Behavioral
Intervention description(s): Families in the intervention group will have a microbiome-friendly nutrition assessment and will also receive groceries one time per week for four weeks to help achieve a more microbiome-friendly diet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment