Condition category
Mental and Behavioural Disorders
Date applied
13/02/2017
Date assigned
16/02/2017
Last edited
16/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
One in five children starting school in England is now overweight or obese. Currently, there is a lack of programs with the aim of preventing obesity in preschool-age children in the UK. Previous research has revealed some positive results in changing some health behaviours related to obesity, such as diet and physical activity. However, overall numbers of obesity continue to rise in some age groups and social backgrounds. It has been suggested that preschool settings such as nursery schools may provide opportunities for promoting healthy lifestyles and also to develop and test behaviour-change programs. ‘The Study of Kids in Preschool’ (SKIP) is a behaviour-change preschool program aimed at improving families eating and encourage families to be more active. The aim of this study is to test whether the nursery staff and parents of preschool children are willing to complete the data collection measures and an intervention to improve health behaviours such as diet and physical activity.

Who can participate?
Families with a preschool child (3-5 years) who attend participating school.

What does the study involve?
Schools are randomly allocated to either receiving the programme or being placed on the waiting list. At the beginning of the programme, parents provide information about their child’s activity level, eating habits, height and weight. Children are given cameras to take pictures of what they eat and drink every day for four days. The programme involves five monthly sessions as well as an introduction for parents. These sessions try to increase physical activity by teaching about healthy eating, healthy behaviours and healthy activity. Parents are given monthly newsletters that include information about healthy eating and ideas on how to get their kids to be more active. Parents also set monthly goals with the school staff in order to continue to make healthy choices with their children at home. At the end of the programme, children are given cameras again to take pictures of what they eat and drink for four days. Schools on the waiting list continue as normal during the study and are given the opportunity to participate in the program six months after the programme has ended.

What are the possible benefits and risks of participating?
Participants may benefit from possibly making changes to the family diet and activity and promoting healthy living. There is a risk that participants may feel pressured to complete the monthly tasks or feeling judged if they were not able to.

Where is the study run from?
Four primary schools located in the North-East of England (UK)

When is the study starting and how long is it expected to run for?
February 2010 to July 2012

Who is funding the study?
Fuse, the Centre for Translational Research in Public Health (UK)

Who is the main contact?
Lorraine McSweeney
lorraine.mcsweeney@ncl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lorraine McSweeney

ORCID ID

http://orcid.org/0000-0003-1044-6201

Contact details

Human Nutrition Research Centre
William Leech Building
Newcastle University
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PhD02

Study information

Scientific title

A feasibility study with process evaluation of a preschool intervention to improve child and family lifestyle behaviours

Acronym

Study hypothesis

Preschool settings may provide valuable opportunities to access children and their families not only for promoting healthy lifestyles, but also to develop and evaluate behaviour-change interventions.

Ethics approval

Newcastle University Faculty of Medical Science Ethics Committee, 09/06/2011, ref: 00303_1

Study design

Cluster randomised feasibility trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Lifestyle behaviour change

Intervention

Four local government preschool centres associated with primary schools in the North East of England consent to participate and are randomised to either the intervention or wait list control groups. In order to reduce selection bias the preschools were allocated to intervention or wait list control by a computerised programme by the Newcastle University Clinical Trials Unit.

Intervention group: Families who agree to take part are asked to provide information about their child’s diet (how often their child watched TV/DVDs, how active their child was and whether the family took part in activities such as walking, swimming etc). This information is recorded in a diary completed by the parents over 4 days before the start of the project and at the end to see if there were any changes. The child’s height and weight are also recorded. To include children in the gathering of information about their diet, they are given disposable cameras and asked to take photographs of everything they ate and drank for four days at the beginning and end of the project. This also provided more information about the child’s diet.

The participating schools receive the intervention titled the Study of Kids in Preschool’ (SKIP) which consists of five monthly modules plus an introductory session for parents. The five monthly preschool-based sessions target the child and aim at increasing physical activity, knowledge of and prompting of healthy eating. Active Behaviour Change Techniques delivered by the preschool staff provide information on modelling and demonstrating behaviour, prompting practice and providing instruction on how to perform the behaviour.

Parents are given monthly newsletters by preschool staff. These newsletters provide dietary and physical activity information and tips for home-based tasks to increase physical activity and healthy eating and decrease screen time. Active Behaviour Change Techniques distributed via the newsletters are self-monitoring of behaviour, goal setting, action planning and coping planning.

Parents are asked to meet with preschool staff members once a month to set goals, monitor and review family health behaviour using written materials provided within the newsletters. The families are encouraged to share ideas, achievements, photographs and drawings of activities on a communal preschool information board. Home-based tasks include family cooking and tasting, ‘No TV day’ and increasing family ‘active time’ challenges.

Control group: Schools are placed on a wait-list and continue as usual for the duration of the study and are given the opportunity to participate six months after the study.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Feasibility of trial procedures and acceptability of the proposed intervention are measured through:
1. Recruitment rates (the number of eligible participants who consent to participate in the study) at baseline
2. Completion rates of data collection tasks by parents such as completion of food diaries including recording of child accelerometer/pedometer use, recording time of child TV viewing and recording of family active time at baseline and 6 months
3. Lost to follow-up (parents) measured by the number of parents who consent to participate that remain in the study until the end of follow-up at 6 months
4. Adherence to the proposed activities by preschools and parents (i.e. number of worksheets, feedback forms and questionnaires received from nursery staff and parents during the duration of the study) at 6 months
5. Number of pictures taken by children/families of meals consumed at baseline and 6 months

Secondary outcome measures

Children:
1. Height and weight are measured using a Leicester portable height measure with the head in the Frankfort plane, and Tanita scales TBF-300MA at baseline and 6 months
2. Physical activity is measured by either Actigraph GT1M accelerometer or ST-101 pedometer at baseline and 6 months
3. Portion size and eating environment (home, school, restaurant, with family alone etc.) are assessed by photographs taken with a digital camera provided to children and food diaries at baseline and 6 months

Parents:
1. Child eating behaviours are assessed using four day food diaries collected at baseline and 6 months
2. Sedentary behaviours are assessed by recording the time in hours/minutes children spend watching TV/DVDs and engaging in active behaviours in daily diaries at baseline and 6 months

Observational measures:
Child food intake when at preschool (2 week days) is recorded using a food checklist at baseline and 6 months

Overall trial start date

08/02/2010

Overall trial end date

16/07/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Families with a preschool child (3-5 years) who attend a local government preschool centre.

Participant type

Other

Age group

Mixed

Gender

Both

Target number of participants

Four clusters - a convenience sample of parents was recruited

Participant exclusion criteria

None

Recruitment start date

11/10/2011

Recruitment end date

25/11/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Falla Park Primary School
Falla Park Road Felling
Gateshead
NE10 9HP
United Kingdom

Trial participating centre

Corpus Christi Primary School
Dunsmuir Grove
Gateshead
NE8 4QL
United Kingdom

Trial participating centre

Brighton Avenue Primary School
Brighton Road
Gateshead
NE8 1XS
United Kingdom

Trial participating centre

Bridgewater Community Primary School
Bridgewater Delaval Road Benwell
Newcastle upon Tyne
NE15 6NL
United Kingdom

Sponsor information

Organisation

Newcastle University

Sponsor details

Richardson Road
Newcastle upon Tyne
NE2 4AX
United Kingdom
+44 191 208 7296
fuse@newcastle.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Fuse, the Centre for Translational Research in Public Health

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high impact peer reviewed journal.

IPD sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from lorraine.mcsweeney@ncl.ac.uk

Intention to publish date

31/03/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes