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Trial registered on ANZCTR

Registration number

ACTRN12614001179628

Ethics application status

Approved

Date submitted

8/10/2014

Date registered

11/11/2014

Date last updated

11/11/2014

Type of registration

Retrospectively registered

Titles & IDs

Public title

The effectiveness of an intervention promoting water consumption among primary school students: A cluster-randomized controlled trial

Scientific title

A cluster-randomized controlled to compare the efficacy between receiving a social-network implemented intervention and none of the intervention on water and sugar-sweetened beverages consumption in primary school students

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

water and sugar-sweetened beverages consumption

overweight/ obesity

Condition category

Condition code

Diet and Nutrition

Obesity

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Selection procedure: Along with the baseline questionnaire, the children in the experimental schools completed peer nominations questions (whom they “respected”, “wanted to be like”, “looked up to”, “went to for advice”, and regarded as “good leaders”) to identify the most influential children in their classroom. Fifteen percent of boys and 15% of girls with the most nominations over all questions were invited for to be trained as peer motivators.

Training: The training was delivered by the experimenter in groups of max. 12 children in a one 90-minute session during school hours. The aim of the training was to give the most influential children the knowledge and skills to promote water consumption within their social networks. The objectives of the training were: (1) to emphasize the benefits of water, (2) to encourage peer motivators to consume more water, and (3) to teach peer motivators skills to promote water consumption within their social network. The children were taught skills to promote water consumption by discussing possible ways through which they can encourage their peers to drink more water.

follow-up sessions: The peer motivators were asked to promote water consumption within their social networks during eight weeks. The experimenters offered support at two school-based follow-up sessions (one and four weeks after the training). The purpose of the follow-up visits was to (1) offer the peer motivators visible support and resolve any problems they experienced in their role and (2) refresh the information that was discussed in the training.

Intervention code [1]

Behaviour

Comparator / control treatment

The control condition schools received none of the intervention.

Control group

Active

Outcomes

Primary outcome [1]

self-reported water consumption (i.e., average amount of glasses on a day)

Timepoint [1]

baseline and 9 weeks

Primary outcome [2]

self-reported sugar-sweetened beverages consumption (i.e., average amount of glasses on a normal day). The question was asked separately for fruit juice, soda, and energy drinks.

Timepoint [2]

baseline and 9 weeks

Secondary outcome [1]

behavioral intentions: participants were asked to indicate on a 4-point scale how likely they were to drink more water.

Timepoint [1]

baseline and 9 weeks

Eligibility

Key inclusion criteria

girls and boys in grade 7 and 8 of the Dutch school system (9 - 13 yrs)
Schools without any water stimulation programs
Parents that provided passive consent for their children Children that were willing and able to provide written consent

Minimum age

9 Years

Maximum age

13 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

schools with water stimulation programs

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

After receiving consent from the headmasters of the schools, the schools were randomly assigned to either the experimental or the control condition by an independent researcher.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation was done using a computerised sequence generation

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

A two-way repeated measures design including one between-group factor (condition: experimental vs. control) and one repeated measure (time: baseline vs. post-intervention) to assess the effect of the intervention.

Power analyses using G*Power indicated that n= 98 for each condition is expected to be sufficient to detect significant (alpha = .05, one-tailed) small effects (d= .25) of
conditions (power = .8).

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

2/12/2013

Actual

6/01/2014

Date of last participant enrolment

Anticipated

Actual

10/01/2014

Date of last data collection

Anticipated

Actual

Sample size

Target

200

Accrual to date

Final

Recruitment outside Australia

Country [1]

Netherlands

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Radboud University Nijmegen

Address [1]

Comeniuslaan 4, 6525 HP Nijmegen
Postbus 9102, 6500 HC Nijmegen

Country [1]

Netherlands

Primary sponsor type

University

Name

Radboud University Nijmegen

Address

Comeniuslaan 4, 6525 HP Nijmegen
Postbus 9102, 6500 HC Nijmegen

Country

Netherlands

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Committee of Radboud University Nijmegen

Ethics committee address [1]

Montessorilaan 3
6525 HR Nijmegen

Ethics committee country [1]

Netherlands

Date submitted for ethics approval [1]

01/01/2014

Approval date [1]

10/03/2014

Ethics approval number [1]

ECSW2014-1003-203

Summary

Brief summary

Overweight and obesity are among the most common public health problems in Western society. One major contributor of obesity in children is the consumption of sugar sweetened beverages. A possible solution to the obesity epidemic is to replace children’s consumption of sugar sweetened beverages with water. With use of the diffusion of innovation theory, the proposed program targeted primary school students aged 9-13 years and aimed to increase water consumption among these students. The program consisted of training opinion leaders to acts as peer supporters during informal interactions and encourage their peers to drink more water. The primary goal of this project was to develop and assess the effectiveness of the  program in primary schools in the Netherlands.

Trial website

Trial related presentations / publications

Not applicable

Public notes

Contacts

Principal investigator

Name

Miss Crystal Smit

Address

Communication Science
Radboud University Nijmegen
P.O. Box 9104, 6500 HE Nijmegen, The Netherlands

Country

Netherlands

Phone

+(31)(0)24 361 572345

Fax

c.smit@maw.ru.nl

Contact person for public queries

Name

Crystal Smit

Address

Communication Science
Radboud University Nijmegen
P.O. Box 9104, 6500 HE Nijmegen, The Netherlands

Country

Netherlands

Phone

+(31)(0)24 361 572345

Fax

c.smit@maw.ru.nl

Contact person for scientific queries

Name

Crystal Smit

Address

Communication Science
Radboud University Nijmegen
P.O. Box 9104, 6500 HE Nijmegen, The Netherlands

Country

Netherlands

Phone

+(31)(0)24 361 572345

Fax

c.smit@maw.ru.nl

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	A social network-based intervention stimulating peer influence on children's self-reported water consumption: A randomized control trial	2016	https://doi.org/10.1016/j.appet.2016.04.011

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically