Condition category
Nutritional, Metabolic, Endocrine
Date applied
25/05/2005
Date assigned
04/07/2005
Last edited
22/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.doitproject.com

Contact information

Type

Scientific

Primary contact

Dr Marijke Jeanette Maidy Chin A Paw

ORCID ID

Contact details

van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 4448203
m.chinapaw@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2000T203

Study information

Scientific title

Dutch Obesity Intervention in Teenagers: a school-based intervention program to improve dietary and physical activity behaviour in adolescents, in order to prevent excessive weight gain

Acronym

DOiT

Study hypothesis

It is hypothesised that the intervention will result in:
1. A difference between the intervention and the control group of at least 0.5 kg of body weight gain in favour of the intervention group after a one-year intervention period
2. Furthermore, a difference between the intervention and control group is expected of 7% (0.5 points on a 7-point scale) in cognitions (i.e. awareness, attitude, subject norm and self-efficacy) and 7% (0.5 points on a 7-point scale) in the behavioural intention of reaching a more favourable energy-balance

Ethics approval

The Medical Ethical Committee of the VU University Medical Center

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Condition

Overweight and obesity

Intervention

An educational program was developed and implemented in the biology and physical education lessons. These lessons aimed at increasing awareness and behavioural changes concerning energy intake, consumption of sugar-sweetened drinks and energy-dense snacks in particular; and energy output i.e. physical activity and sedentary behaviours. In addition, schools were advised on modifying the canteens, and requested to provide additional physical education classes in order to facilitate behavioural change.
Furthermore, participants are requested to choose at least one of four intervention options aimed at the individual, two regarding physical activity and two regarding food intake.

Control intervention: The regular school curriculum.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Weight, height, and body composition (based on waist, arm, and thigh circumferences, and four skinfolds: triceps, biceps, subscapular, supra iliac), dietary behaviour (by questionnaires focusing on snacking and soft drinks), physical activity (by questionnaire in the whole group, and in a subgroup by accelerometers) and physical inactivity (by questionnaire).

Secondary outcome measures

1. Cognitions and intention (awareness, attitude, subjective norms, descriptive norms, self-efficacy - by questionnaire) related to recommended physical activity levels and dietary behaviours
2. Intention towards reaching a more favourable energy-balance
3. Compliance and appraisal of trial components (all by questionnaire)
4. Aerobic fitness by the 20 m shuttle run-test

Overall trial start date

01/08/2002

Overall trial end date

31/08/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Dutch adolescent boys and girls aged 12 - 14 years attending pre-vocational education

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

1070

Participant exclusion criteria

No exclusion criteria

Recruitment start date

01/08/2002

Recruitment end date

31/08/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Sponsor information

Organisation

The Netherlands Heart Foundation (NHF) (The Netherlands)

Sponsor details

Bordewijklaan 3
Postbus 300
The Hague
2501 CH
Netherlands
+31 (0)70 315 55 55
info@hartstichting.nl

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

The Netherlands Heart Foundation (NHF) (The Netherlands) (ref: 2000T203)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/17173701
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25044777

Publication citations

  1. Protocol

    Singh AS, Chin A Paw MJ, Kremers SP, Visscher TL, Brug J, van Mechelen W, Design of the Dutch Obesity Intervention in Teenagers (NRG-DOiT): systematic development, implementation and evaluation of a school-based intervention aimed at the prevention of excessive weight gain in adolescents., BMC Public Health, 2006, 6, 304, doi: 10.1186/1471-2458-6-304.

  2. Results

    van Nassau F, Singh AS, van Mechelen W, Brug J, Chinapaw MJ, Body mass index, waist circumference and skin-fold thickness in 12- to 14-year-old Dutch adolescents: differences between 2003 and 2011, Pediatr Obes, 2014 , 9, 6, e137-e140, doi: 10.1111/ijpo.233.

Additional files

Editorial Notes