A Study of the Effect of Replacing Sugary Drinks by Low-sugar Alternatives on Body Weight and Fat Mass in Children
Condition: Body Weight
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      Obesity results from an imbalance between energy intake and energy expenditure. There is much
      speculation about foods that are particularly fattening, and sugary drinks are seen as major
      culprits. It is hypothesized that a high intake of calories from sugary drinks would not be
      compensated for by reduced food intake at subsequent meals. As a result, body weight would
      increase. In this double-blind, long term, randomized controlled trial the effect of
      replacing sugar-containing beverages by low-sugar alternatives on body weight and fat mass in
      children will be investigated.
    

Detailed description: 
      Rationale: Liquid carbohydrates (including soft drinks as well as fruit juices) are thought
      to be less satiating then solid carbohydrates (e.g., bread or fruits). The hypothesis is that
      calories from sugary drinks might not be compensated for by eating less at subsequent meals
      and body weight would increase. In this way liquid carbohydrates might be one of the causes
      of becoming overweight and obesity. However, the evidence for a causal relation between
      sugary drinks and weight gain is inconclusive.

      Objective: To test the effect of replacing sugar-containing beverages by beverages low in
      sugar on body weight and fat mass in children aged 5-10 years.

      Study design: A double-blind, long term, randomized controlled trial.

      Study population: Healthy school children in the age of 5-10 years old. We consider it
      unethical to encourage children to drink sugary drinks. Therefore children are only eligible
      if they already habitually consume 250 mL per day or more of sugary drinks.

      Intervention: Six hundred healthy children (5-10 years) will be divided randomly into 2
      groups. Group 1 (n=300) receives 250 mL per day of sugar-containing lemonade. Group 2 (n=300)
      receives 250 mL per day of lemonade low in sugar. The low-sugar drinks are sweetened with
      artificial sweeteners. The drinks will be consumed during the morning break during the
      weekdays at school and at home during weekends and holidays. The intervention period will be
      18 months.

      Before the main trial starts feasibility and logistics will be tested in a pilot study. The
      design of the pilot study will be a 2-month randomized controlled trial in approximately 80
      school children aged 5-10 years.

      Main study parameters/endpoints: The primary outcome of the study is children's body weight
      (body mass index, corrected for age). Secondary endpoints are waist circumference, skin folds
      and bioelectrical impedance. These outcomes will be measured four times during the study, at
      0, 6, 12 and 18 months. As a secondary outcome we will also perform a sensory evaluation at
      0, 6, 12 and 18 months and a questionnaire about dental health at 12 and 18 months.
    

Intervention name(s): lemonade with sugar; lemonade low in sugar
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 250 milliliters of lemonade with sugar daily for 18 months; 250 milliliters of lemonade low in sugar daily for 18 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: overweight; children; intervention; sugar-sweetened beverages