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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR1796 |
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Date of registration:
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04/05/2009 |
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Primary sponsor: |
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Public title:
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A Study of the Effect of Replacing Sugary Drinks by Low-Sugar Alternatives on Body Weight and Fat Mass in Children (DRINK).
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Scientific title:
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A double blind, randomized trial of the effects of liquid carbohydrates on body weight and fat mass in school children. - DRINK study |
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Date of first enrolment:
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1/5/2009 |
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Target sample size:
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600 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1796 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Margreet R.
Olthof |
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Address:
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De Boelelaan 1085, De Boelelaan 1085
1081 HV
Amsterdam
The Netherlands |
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Telephone:
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+31 205982522 |
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Email:
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margreet.olthof@falw.vu.nl |
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Affiliation:
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Name:
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Margreet R.
Olthof |
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Address:
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De Boelelaan 1085, De Boelelaan 1085
1081 HV
Amsterdam
The Netherlands |
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Telephone:
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+31 205982522 |
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Email:
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margreet.olthof@falw.vu.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Healthy school going boys and girls;
2. Age 5 years and older, children still have to be in elementary school at the end of the study;
3. Children who already habitually consume 250 mL per day or more of sugary drinks.
Exclusion criteria: 1. Using medication or under medical treatment for obesity;
2. Any acute or chronic disease such as diabetes, growth disorders, celiac disease, or serious gastroenterological diseases;
3. Medical history or surgical events known to interfere with the study;
4. Participation in another intervention trial up to 3 months before and during the study, if the intervention interferes with the current study;
5. Physical disabilities that hamper the measurements;
6. Intention to change location of residence and primary school during the study period.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Overweight, Obesity
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Intervention(s)
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1. Intervention 1: 250 mL per day of sugar-containing lemonade;
2. Intervention 2: 250 mL per day of lemonade low in sugar. The low-sugar drinks are sweetened with artificial sweeteners.
The intervention will take 18 months.
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Primary Outcome(s)
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BMI z-score.
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Secondary Outcome(s)
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1. Waist circumference;
2. Bioelectrical impedance (% fat mass);
3. Sum of four skinfolds (mm);
4. Dental health;
5. Sensory evaluation.
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Secondary ID(s)
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120520010 / 2008B096
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Source(s) of Monetary Support
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ZON-MW, The Netherlands Organization for Health Research and Development, Netherlands Heart Foundation (NHS, Nederlandse Hartstichting), Royal Netherlands Academy of Arts and Sciences
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