PrOtein and WEight Loss in teenageRs
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity; Weight Loss
Study type: Interventional

Summary: 
      The aim of the proposed study is to provide important data on weight loss efficacy in
      overweight and obese adolescents on an isocaloric higher protein diet vs a lower protein diet
      utilizing the U.S. Department of Agriculture (USDA) MyPlate nutrition guide. The
      investigators hypothesize that the higher protein diet will result in greater weight loss due
      to increased satiety and better dietary adherence.
    

Detailed description: 
      Aim 1 is to test the efficacy of a personalized higher protein weight loss intervention
      compared to a lower protein intervention which use the USDA MyPlate nutrition guide.

      It is hypothesized that participants randomly assigned to the higher protein dietary
      treatment will lose more weight based on BMI-Z score over 12 weeks compared to participants
      in the lower dietary protein treatment.

      Aim 2 is to test if changes in subjective ratings of appetite differ by dietary treatment
      (i.e. protein intake).

      It is hypothesized that participants in the higher protein intervention will report a
      decrease in hunger and an increase in fullness compared to participants in the lower protein
      intervention.

      Aim 3 is to test if change in the hexosamine biosynthetic pathway (HBP) measured at the rate
      limiting step of glutamine fructose-6-phosphate amidotransferase (GFAT) and glycosylation
      measured as O-linked N-acetylglucosamine (GlcNAc) transferase (OGT) differ by dietary
      treatment.

      It is hypothesized that participants randomly assigned to the higher protein dietary
      treatment will have decreased change from baseline levels of GFAT and glycosylation (OGT) due
      to decreased carbohydrate intake compared to the lower protein treatment.

      Exploratory Aims: As exploratory aims, the investigators will test if the higher protein or
      lower protein dietary treatments differentially alter glucose, insulin, cholesterol, and
      triglycerides (markers of the metabolic syndrome).
    

Intervention name(s): Energy Restriction; Higher protein; Lower Protein
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will receive an intervention specifically designed for adolescents and their group assignment that relies on nutrition education, nutritional counseling, social cognitive therapy, behavioral strategies, self-monitoring, portion size reduction, and increased physical activity.
Participants will get an individualized dietary meal plan. Dietary counseling will be based on the MyPlate guidelines with extra attention and focus on appropriate protein food choice. Also in accordance to the MyPlate guidelines, all participants will be instructed to increase physical activity to 60 minutes a day as aerobic physical activity.; The higher protein group will be instructed to consume 30% of energy as protein, with 25% and 45% of energy from fat and carbohydrate, respectively.; The lower protein group will be instructed to consume 15% of energy as protein, with 25% and 60% of energy from fat and carbohydrate, respectively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adolescent obesity; childhood obesity; anthropometry; body weights and measures