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Sedentary LifestyleNCT03993652

Kids FIRST: Family-based Intervention to Reduce Snacking and Screen Time in Children

A study testing Kids FIRST in people with Sedentary Lifestyle and Sedentary Behavior, run by Loughborough University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Kids FIRST was a 12-week, four arm, home- and school-based pilot randomised controlled trial to reduce screen-time and unhealthy snacking with assessments at pre- (baseline) and post-intervention. Read more about this study

Who is it for?
Ages 5 to 11 yearsHealthy volunteers can take part
What is being tested?
Kids FIRST
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
No sites listed yet
Study dates
1 Sep 2015to 1 Sep 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • The study targeted families with at least one 5-6 and/or 9-11 year old child.

Who cannot join

  • -

About this study

Official title: Kids FIRST: Development and Feasibility of a Family-based Intervention to Reduce Snacking and Screen Time in Children

Kids FIRST was a 12-week, four arm, home- and school-based pilot randomised controlled trial to reduce screen-time and unhealthy snacking with assessments at pre- (baseline) and post-intervention. Four UK schools were randomised to control or one of three interventions - Group 1: targeting reductions in screen-time and unhealthy snacking (ST+Sn), Group 2: targeting reductions in screen-time only (ST), Group 3: targeting reductions in unhealthy snacking only (Sn). Intervention group parents received four online 'sessions' and four packages of resources which were tailored to each intervention group and focused on specific mediators of screen-time and/or unhealthy snacking. Children received four 30-minute lessons during school time, followed by homework activities/challenges. Children and parents reported their own screen-time behaviours, children reported their own snacking behaviours, and completed questionnaires on individual, behavioural, social and physical home environmental variables. Descriptive analyses were undertaken using principles of intention to treat.

Read the detailed description

The Kids FIRST intervention was performed and reported in accordance with the Consolidated Standards of Reporting Trials extension to randomised pilot and feasibility trials guidelines. The study was approved by the Ethical Advisory Committee of Loughborough University (R15-PO36).

Setting and recruitment Kids FIRST was family based with a school component. The study targeted families with at least one 9-11 year old child. Families were recruited through schools in the East Midlands region of the United Kingdom between September and December 2015. Twenty-five primary schools were selected from a database of schools and school contacts. Headteachers were sent study information via email, which was followed-up with a telephone call, inviting them to be part of the project. In participating schools, parents/caregivers of children aged 9-11 years (year 5 and 6 of Primary School) were sent information sheets via the school outlining the study details and inviting them and their child to participate.

Study design The study was a pilot four-arm cluster randomised controlled trial with assessments at pre- (baseline) and post-intervention (13 weeks after baseline). The study arms were three intervention groups and a control group. The intervention groups were: Group 1: targeting reductions in screen-time and unhealthy snacking (ST+Sn), Group 2: targeting reductions in screen-time (ST), and Group 3: targeting reductions in unhealthy snacking (Sn). Following consent by headteachers, schools were randomised to either one of the three intervention groups or the control group by NP using computer generated random sequences. Only NP had access to the randomisation sequences (which were on a password protected file). This method of randomisation eliminated the possibility of contamination between pupils and parents from the same school.

Theoretical underpinning of the Kids FIRST intervention The Kids FIRST intervention was framed in a social ecological perspective, and was theoretically informed, drawing on constructs designed to address potential individual, behavioural, social and physical home environmental mediators derived from Habit Theory, Behavioural Choice, and Social Cognitive theories of individual behaviour change.

The taxonomy of behaviour change techniques was applied to characterise the association between the potential mediators targeted in the Kids FIRST study, the intervention components / strategies developed, and the theoretical underpinning. Supplementary Table 1 describes the specific behaviours that were targeted by the intervention and the practical application of the behaviour change techniques applied in relation to the Kids FIRST intervention.

Kids FIRST intervention overview The intervention was implemented over a 12-week period from October 2015 to May 2016 (rolling recruitment of schools) following the baseline assessments. Families in each of the three intervention arms received the same structure of intervention, but the content was tailored to the targeted behaviour(s). Parents and children attended an introductory group session at school which provided an overview of the programme. Families in the control group did not receive any resources or engage with any sessions. No changes to the trial methods were implemented after the commencement of the programme.

Family setting The intervention consisted of four blocks of three weeks. Each block targeted and focused on specific evidence-based mediators. All intervention families were given access to the Kids FIRST website (which was live for the duration of the study only), which included a login page where families were directed to the content/pages that were specific to their intervention group (i.e. families in group 1 could only access the webpages for group 1) by a group sensitive password. During each block, parents in each intervention group received one online session, and a package of resources (e.g. newsletters, information sheets, charts etc.) delivered via their child from school. The online sessions introduced the topic of the block to the parents and were followed by the newsletters and resources which prompted 'try at home' activities and challenges with a focus on the specific mediators. Online sessions were delivered via PowerPoint or an audio file and were focused on providing parents with support in the form of informational and cognitive, behavioural, environmental, and social support intervention components as a means of empowering families to make behavioural changes that were specific to them. The newsletters and resources (e.g. monitoring charts, top tips, recipes, and alternative activity or snack ideas) aimed to support the key learning messages delivered in the online sessions and to the children in the classroom lessons (see below).

The key messages of the programme, which were reinforced at each block of the intervention, were:

  • Increase knowledge about ST/Sn outcomes (health and other);
  • Increase awareness and implementation of strategies to participate in healthy ST and/or consumption of healthy snacks
  • Guide parents on how to implement behaviour modification, such as planning and monitoring.

School setting Children randomised to an intervention received four 30-minute lessons during school time over the intervention period (one per 'block'). Key learning messages incorporating key principles of behaviour change were delivered to whole year group classes by trained research personnel. The class lessons were followed by homework activities/challenges and were aimed at the children and were designed to (i) target habits and self-efficacy, (ii) target screen-time and/or nutritional knowledge; (iii) introduce alternative activities/snacks, and (iv) encourage role modelling. Lessons were designed with class teachers prior to the commencement of the programme and incorporated literacy and numeracy aspects that were aligned to the national curriculum specific for each age group.

Being tested
Kids FIRST
Medical subject headings
Sedentary Behavior, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kids FIRSTBehavioural

    family- and school-based intervention to reduce unhealthy screen-time and snacking

Study groups in NCT03993652
Study groupRoleWhat they receive
Screen-time and SnackingExperimentalAim: to reduce both screen-time and unhealthy snacking
Receives: Behavioral: Kids FIRST
Screen-time onlyExperimentalAim: to reduce screen-time only
Receives: Behavioral: Kids FIRST
Snacking onlyExperimentalAim: to reduce unhealthy snacking only
Receives: Behavioral: Kids FIRST
ControlNo interventionControl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time spent engaged in screen-time

    minutes per week engaged in sedentary screen-time

    Measured: 3 months

  2. Frequency of consumption of energy-dense snack foods, fruits and vegetables

    Daily frequency of consumption of energy-dense snack foods

    Measured: 3 months

Secondary outcomes (2)
  1. Time parents spend engaged in screen-time

    minutes per day that parents engaged in sedentary screen-time

    Measured: 3 months

  2. parent consumption of energy-dense snacks

    Daily frequency of consumption of energy-dense snack foods

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2019
  2. Study start1 Sep 2015
  3. Primary completion1 Sep 2016
  4. Study completion1 Sep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
4-arm intervention. 3 interventions that received the same model but tailored to behavioural target. control group received no treatment
Masking
Single blind
Who is masked
Investigator
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03993652
Sponsor's protocol ID
PG/12/70/29777
Status last verified
Jun 2019
First submitted
18 Jun 2019
Last updated
28 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Unsure

Publications

  • Pearson N, Biddle SJH, Griffiths P, Sherar LB, McGeorge S, Haycraft E. Reducing screen-time and unhealthy snacking in 9-11 year old children: the Kids FIRST pilot randomised controlled trial. BMC Public Health. 2020 Jan 29;20(1):122. doi: 10.1186/s12889-020-8232-9.

    PubMed 31996192

Questions about this trial

What is this clinical trial studying?

A study testing Kids FIRST in people with Sedentary Lifestyle and Sedentary Behavior, run by Loughborough University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time spent engaged in screen-time (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03993652, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.

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