A double-blind randomized trial of the efficacy of replacing sugary drinks by low sugar alternatives on body weight and fat mass in school schildren aged 5-10 years
- Conditions
- overgewicht/obesitasobesityoverweight
- Registration Number
- NL-OMON33427
- Lead Sponsor
- Vrije Universiteit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 600
- Healthy school going boys and girls
- Age 5 years and older, children still have to be in elementary school at the end of the study.
- Children who already habitually consume 250 mL per day or more of sugary drinks.
- Using medication or under medical treatment for obesity
- Any acute or chronic disease such as diabetes, grow disorders, celiac disease, or serious gastro-enterology (for example inflammatory bowel disease).
- Medical history or surgical events known to interfere with the study
- Participation in another intervention trial up to 3 months before and during the study if the intervention interferes with the current study
- Physical disabilities that hamper the measurements
- Intention to change location of residence and primary school during the study period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcomes of the study are the children*s bodyweight (body mass<br /><br>index, corrected for age), waist circumference, skin folds and bioelectrical<br /><br>impedance. These outcomes will be measured four times during the study, at the<br /><br>start, after 6, 12 months and at the end of the study. As a secondary outcome<br /><br>we will also assess food intake of the children at lunch time, shortly after<br /><br>the morning break when the children have consumed the study drinks. This<br /><br>outcome will be measured at the start and at the end of the study.</p><br>
- Secondary Outcome Measures
Name Time Method <p>As a secondary outcome we will also assess food intake of the children at lunch<br /><br>time, shortly after the morning break when the children have consumed the study<br /><br>drinks. This outcome will be measured at the start and at the end of the study.</p><br>