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

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 - DRINK-study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33427

Enrollment

600

Registered

2009-04-24

Start date

2009-09-29

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

overgewicht/obesitas obesity overweight

Interventions

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 drinks (Unilever peach drink, Unilever mango drink, Unil

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: - 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.

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
The primary outcomes of the study are the children*s bodyweight (body mass index, corrected for age), waist circumference, skin folds and bioelectrical impedance. These outcomes will be measured four times during the study, at the start, after 6, 12 months and at the end of the study. As a secondary outcome we will also assess food intake of the children at lunch time, shortly after the morning break when the children have consumed the study drinks. This outcome will be measured at the start and at the end of the study.	—

Measure

Time frame

The primary outcomes of the study are the children*s bodyweight (body mass index, corrected for age), waist circumference, skin folds and bioelectrical impedance. These outcomes will be measured four times during the study, at the start, after 6, 12 months and at the end of the study. As a secondary outcome we will also assess food intake of the children at lunch time, shortly after the morning break when the children have consumed the study drinks. This outcome will be measured at the start and at the end of the study.

—

Secondary

Measure	Time frame
As a secondary outcome we will also assess food intake of the children at lunch time, shortly after the morning break when the children have consumed the study drinks. This outcome will be measured at the start and at the end of the study.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)