Condition category
Not Applicable
Date applied
12/06/2014
Date assigned
10/04/2015
Last edited
08/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Nearly 10% of children aged 4 to 5 in England are obese and more than 13% are overweight. . In Wales over 11% of children aged 4-5 are obese and 15% are overweight. Obesity is more common in children from poorer backgrounds. However, we have little information about how to prevent young children becoming obese. It is recommended that pre-school children are physically active for at least 3 hours per day. Yet, only one third of 2 to 4 year olds are physically active for at least 60 minutes per day. Young children do not eat enough fruits and vegetables and most of their sugar intake is from soft drinks. It is important that care environments are healthy to reduce the risk of obesity. Over 3 million children attend some form of child care in England. In England and Wales free child care is available for children aged 3 to 4. This study will aim to test whether we can adapt and use a 6 month programme from the United States called “The Nutrition and Physical Activity Self Assessment for Child Care” (NAP SACC). We will make changes to use it in the UK and test whether we can work with child care providers to make the environments more healthy.

Who can participate?
Child care providers in North Somerset and Cardiff will be invited to take part in the study if they provide a main meal to children. The providers will include day nurseries, private nursery schools, maintained nurseries, Children’s Centres with nurseries and pre-schools. Parents of children aged 2-4 in the child care providers will be asked if they would like their child to take part. Children can take part if they receive an average of at least 12 hours per week of child care and receive at least 1 main meal per week provided by the setting.

What does the study involve?
We will work with child care providers and parents before we start using NAP SACC to find out how we need to change to use it in the UK. We will invite child care providers and parents of children in these providers to take part. We will work with 12 providers. Six will be chosen at random to receive NAP SACC UK and six will be chosen at random not to receive NAP SACC UK. The six providers receiving NAP SACC UK will use the NAP SACC UK self assessment tool (‘Review and Reflect’) to assess their environment with respect to food, drink and physical activity. They will then work with trained staff (NAP SACC UK Partners) to action plan and set goals to make improvements in areas that have been identified as not meeting best practice. This will be supported by workshops and ongoing support over six months. The other half of child care centres will not receive the programme but will take part in the measurements. At the beginning and end of the study we will take measurements from the children in all twelve child care providers. With the parent’s agreement we will measure the child’s height, weight, physical activity levels and diet. We will also collect information from parents about the child’s quality of life. We will collect information about the costs of providing NAP SACC UK. We will be interested in whether it is possible to take the measurements. We will also be interested in comparing the group who have the NAP SACC UK intervention and those who did not. This will help us to see if there may be benefits from using NAP SACC UK. We will also be able to calculate how many child care providers and children we would need for a larger study. At the beginning and end of the study we will talk to child care staff, staff who work to support child care providers and parents about their views on the study.

What are the possible benefits and risks of participating?
The child care providers will gain from having an expert work alongside them to review and offer suggestions for improving the child care environment. The risks of taking part are very small and mainly involve the time taken to participate in the study, the assessments, communication with parents and measurements with children.

Where is the study run from?
The study is led by the University of Bristol with staff involved from the Universities of Cardiff, Glasgow and North Carolina at Chapel Hill.

When is the study starting and how long is it expected to run for?
September 2014 to April 2017

Who is funding the study?
The research costs are funded by the National Institute of Health Research. The costs for running the programme are funded by North Somerset Council and Public Health Wales.

Who is the main contact?
Dr Ruth Kipping
ruth.kipping@bristol.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ruth Kipping

ORCID ID

http://orcid.org/0000-0002-5446-8077

Contact details

School of Social and Community Medicine
University of Bristol
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PHR 12/153/39

Study information

Scientific title

NAP SACC UK: A feasibility cluster randomised controlled trial in child care settings to increase physical activity and healthy eating in 2-4 year olds

Acronym

NAP SACC UK

Study hypothesis

1. Can the NAP SACC child care intervention from the US be adapted and developed for use in the UK?
2. Does the child care intervention have the potential to increase healthy eating, increase physical activity and decrease sedentary time among 2-4 year old children in child care provider settings?
3. Is it feasible to conduct a cluster RCT evaluation of NAP SACC in child care providers in the UK and how should such a trial be designed?

Ethics approval

1. Phase 1: Intervention adaptation and development - Wales REC 3, 15/09/2014, ref: 14/WA/1134
2. Phase 2: Pilot RCT - Wales REC 3, 18/03/2015, ref: 15/WA/0043

Study design

Feasibility cluster randomised controlled trial with process evaluation and collection of costs to inform a future assessment of cost-effectiveness. The study is multi-centred with two centres.

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

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

Condition

Physical activity, sedentary time and diet

Intervention

The Nutrition and Physical Activity Self Assessment for Child Care (NAP SACC) -http://www.napsacc.org/ - is an intervention delivered in child care centres with the aim of improving policies, practices and the nutrition and physical activity environment, through a process of self-assessment and targeted assistance. NAP SACC is a theory-based programme that employs components of social cognitive theory and socio-ecological framework. Goals of the programme are to improve:
1. The nutritional quality of food served
2. Amount and quality of physical activity
3. Staff-child interactions
4. Centre nutrition and physical activity policy

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

For the purposes of the feasibility study, the primary outcomes are the acceptability of the intervention and the trial methods.

Secondary outcome measures

1. Environment and Policy Assessment and Observation (EPAO) Instrument score: The (EPAO) instrument was developed for NAP SACC14 and assesses child-care nutrition and physical activity environments, policies, and practices and was developed using the standards, recommendations, and research literature upon which the NAP SACC intervention itself was based. The EPAO consists of a 1-day observation and review of pertinent centre documents using 75-item responses, with the average of all subscale scores representing total nutrition and physical activity scores. The EPAO will be administered by a researcher who will receive a day of training and be blind to child care provider allocation. . The EPAO will be adapted for use in the UK prior to use.
2. Anthropometric measures of children (zBMI and proportion of overweight and obese, as determined by the UK1990 age and gender reference charts at 85% and 95% centiles, respectively; with further sensitivity analysis using the International Obesity Task Force thresholds). All anthropometric measurements will be completed with children in a private area with two DAB checked trained fieldworkers present and a member of nursery staff. Weight will be measured without shoes in light clothing to the nearest 0.1kg using a Seca digital scale. Height will be measured, to the nearest 0.1cm, without shoes using a portable Harpenden stadiometer. Fieldworkers will be trained to ensure correct position for height assessment.
3. Accelerometry measured activity (mean minutes of sedentary, light, moderate and vigorous activity per day). We will use ActiGraph accelerometers which have been described as ‘the most widely used and extensively validated accelerometer for assessment of physical activity among children’. We have extensive experience (with over 8000 children) of collecting and processing Actigraph accelerometer data. Accelerometers have been widely used with pre-school aged children. Accelerometers will be worn for five days. Periods of 60-minutes with zero values will be interpreted as time that the monitor is not worn. A day will be considered valid if 8 hours of data are recorded. Mean minutes of sedentary, light, moderate and vigorous intensity physical activity will then be processed using the criteria proposed by van Cauwenberghe et al. Mean accelerometer counts per minute, which provides an indication of the overall volume of physical activity in which the children engage will also be calculated as this approach facilitates comparison with studies that may have applied a different cut-point.
4. Children’'s food and drink intake specifically fruit and vegetables, snacks and sugar sweetened drinks. Dietary assessment will be performed using the CADET (Child and Diet Evaluation Tool) diary as a 24 hour recall. CADET will be completed by trained fieldworkers for the hours the child is in nursery, and the children’'s parents (to reflect diet at home) by self-completion. Trained staff will contact non-responders by telephone to complete CADET.

All outcomes (primary and secondary) will be measured at baseline and after approximately 12 months.

Overall trial start date

01/09/2014

Overall trial end date

30/04/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Participants for Phase 1:
1. Child care provider managers and staff in day nurseries, private nursery schools, maintained nurseries, children’s centres with nurseries and pre-schools
2. Health Visitors in North Somerset
3. Healthy Preschool Programme staff in Cardiff and the Vale of Glamorgan
4. Early Years’ staff working at local authorities in North Somerset and Cardiff
5. Parents/carers with children aged 2-4 attending child care providers in North Somerset and Cardiff

Participants for Phase 2:
1. Child care provider managers and staff recruited to the trial
2. NAP SACC Partners (health visitors in North Somerset and Healthy Preschool Programme staff in Cardiff)
3. Parents/carers in the recruited providers with children aged 2-4 attending the providers recruited to the trial
4. Children aged 2-4 attending child care in the recruited providers attending for at least an average of 12 hours per week across the year (15 hours per week term time only), being provided with at least 1 main meal by the child care setting

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

12 child care providers and 168 children.

Participant exclusion criteria

1. Child care settings in North Somerset and Cardiff which are:
1.1. Childminders
1.2. Crèches
1.3. Playgroups
1.4. Primary school reception classes, where schools operate an early admission policy to admit four year olds
1.5 Au pairs
1.7 Child care providers previously or currently participating in the Wales Healthy and Sustainable Preschool Scheme
1.8 Child care providers defined as ‘Flying Start’ centres
2. Children aged <2 and >4 in providers which are recruited
3. Children where the parents know the child will be leaving the child care provider during the academic year September 2015-August 2016
4. Children whose parents/carers refuse consent for measurements

Recruitment start date

01/05/2015

Recruitment end date

31/10/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bristol
Bristol
BS8 2PS
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

c/o Dr Birgit Whitman
Research & Enterprise Development (RED)
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Funder name

North Somerset Council

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Public Health Wales

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

Stored in repository

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27053273

Publication citations

Additional files

Editorial Notes

08/04/2016: Publication reference added.