Prevention of Comorbid Depression and Obesity in Attention-deficit/ Hyperactivity Disorder
Condition: Attention-Deficit / Hyperactivity Disorder; Depression; Obesity
MeSH terms: Hyperkinesis; Obesity; Depression; Depressive Disorder; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Depression and obesity are very common among adolescents and young adults with
      attention-deficit/ hyperactivity disorder (ADHD). However, intervention programmes to prevent
      these comorbid disorders rarely exist. In a pilot randomized-controlled study we test two
      newly developed intervention programmes that do not involve medication: bright light therapy
      and physical exercise. Both interventions will be supported by a mobile Health application to
      monitor and feedback intervention success and booster patients' motivation.
    

Detailed description: 
      The risk for comorbid major depressive disorder and obesity is increased in adolescents and
      adults with attention-deficit/ hyperactivity disorder (ADHD), and adolescent ADHD predicts
      adults major depressive disorder and obesity. Nonpharmacological interventions to prevent
      these comorbidities are urgently needed. Bright light therapy (BLT) improves day-night rhythm
      and is an established therapy for major depression in adolescents and adults. Exercise
      prevents and reduces obesity in adolescents and adults and also improves depressive symptoms.
      Interestingly, a reinforcement-based intervention using a mobile health app (m-Health)
      resulted in improved effects on weightloss in obesity. The aim of the current pilot
      randomized-controlled phase-IIa study is to establish feasibility and effect sizes of two
      kinds of interventions, BLT and exercise, in combination with m-Health based monitoring and
      reinforcement in adolescents and young adults aged 14 to 45 years old with ADHD, targeting
      the prevention of depressive symptoms and obesity. In addition, immediate and long-term
      treatment effects on ADHD specific psychopathology, health related quality of life, fitness
      and body related measures, neurocognitive functions and chronotype are explored. Furthermore,
      saliva samples are taken in a subgroup of adult patients to explore the effects of BLT and
      exercise on concentrations of hormones. This subgroup of adult patients will also participate
      in an additional neuroimaging study of the reward system in order to explore intervention
      effects on striatal reward reactivity.
    

Intervention name(s): Bright light therapy; Physical exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mobile therapeutic light (10.000 LUX, white light without UV light), daily (except Sunday) for 30 min in the morning or evening for 10 weeks in total at home provided by a bright light therapy device (Philips EnergyLight HF 3419). Monitoring and feedback will be realized with the m-Health system comprising of a smartphone equipped with the m-Health App, and an activity sensor equipped with a light sensor to monitor the light exposure of the participant.; During 10 weeks participants perform three days of aerobic activities proposed and in two of these days also do muscle-strengthening exercise. Specifically, a training day consists of: (i) a 5-min warm-up period, (ii) a 10-35 min of muscle-strength training on two of the three days, (iii) a 20-40 min of aerobic training, (iii), and a 5-min of flexibility/stretching cool-down. During the course of the 10 weeks, the duration and intensity of the exercises will increase gradually.
Instruction, monitoring, and feedback will be realised by the m-Health system including a smartphone equipped with the m-Health app and Secure Digital Memory cards to store the exercise videos as well as an activity sensor equipped with a mobile sensor for the acquisition of physical activity.
Other intervention name(s): Device: smartphone with m-Health app; Device: Philips EnergyLight HF 3419; Device: smartphone with m-Health app
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, observer-blinded, controlled, multi-centre, pilot phase-IIa parallel-group design with three arms (two treatment groups and one control group); three trial phases: baseline assessment, 10 weeks of treatment versus treatment as usual; 12 weeks post-treatment observation period.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: attention-deficit / hyperactivity disorder; depression; obesity; prevention; bright light therapy; exercise; mobile healthy system