Weight Management for Adolescents With IDD
Condition: Developmental Disabilities; Weight Loss; Body Weight; Down Syndrome; Body Weight Changes; Intellectual Disability
MeSH terms: Down Syndrome; Intellectual Disability; Body Weight; Weight Loss; Body Weight Changes; Developmental Disabilities
Study type: Interventional

Summary: 
      The goal of this study is to explore the impact of two different diets (conventional vs.
      enhanced stop light) and two different delivery systems (face-to-face vs. remote) on weight
      across 18 months in overweight and obese adolescents with intellectual and developmental
      disabilities.
    

Detailed description: 
      Rates of obesity and obesity related chronic health conditions are higher in adolescents with
      Intellectual and Developmental Disabilities (IDD) than those in the general population. Many
      of the negative health consequences observed in obese adults are already present in obese
      adolescents with IDD.

      This study is a 3 group randomized trial to evaluate the intervention delivery system and
      type of reduced energy diet. The investigators will randomize 123 overweight/obese
      adolescents with mild to moderate IDD to one of 3 groups for an 18 month trial (6 month
      weight loss; 12 month weight maintenance):

      group 1) Face-To-Face/CD

      group 2) Technology delivery/CD

      group 3) Technology delivery/eSLD.

      All participants will receive a progressive program of physical activity. Participants on the
      CD diet will be asked to consume a nutritionally balanced, reduced energy, high volume, lower
      fat ( fat=20-30% energy) diet. Participants on the eSLD will consume pre-packaged portion
      controlled meals with the addition of 5 fruits and vegetables per day.

      FTF will meet with a health educator and will track progress using pen and paper records for
      both physical activity and diet. TECH groups will receive the intervention using an iPad with
      the FaceTimeTM application for video meetings with a health educator and will track progress
      using the Lose it! application for both physical activity and diet.
    

Intervention name(s): Enhanced Stop Light Diet (eSLD); Conventional Diet (CD); Face-to-face (FTF); Technology (TECH); iPad with FaceTime
Intervention type(s): Dietary Supplement; Dietary Supplement; Behavioral; Behavioral; Other
Intervention description(s): eSDL includes reduced energy portion controlled meals for 6 months, encouraged consumption of lower energy shakes and 35 fruits and vegetables per week.; CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet.; FTF will meet with a health educator in person and will track progress using pen and paper records for both physical activity and diet.; TECH groups will receive the intervention using an iPad with the FaceTimeTM application for video meetings with a health educator and will track progress using the Lose it! application for both physical activity and diet.; TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diet; Obesity; Adolescents; Intellectual and Developmental Disability