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.
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
- Conditions the study is for
- Sedentary Lifestyle, Sedentary Behavior, Diet Habit
- What is being tested?
- Kids FIRST
- Type of treatment
- Lifestyle or therapy programme
- 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.
- Conditions
- Sedentary Lifestyle, Sedentary Behavior, Diet Habit
- 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 group | Role | What they receive |
|---|---|---|
| Screen-time and Snacking | Experimental | Aim: to reduce both screen-time and unhealthy snacking Receives: Behavioral: Kids FIRST |
| Screen-time only | Experimental | Aim: to reduce screen-time only Receives: Behavioral: Kids FIRST |
| Snacking only | Experimental | Aim: to reduce unhealthy snacking only Receives: Behavioral: Kids FIRST |
| Control | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent engaged in screen-time
minutes per week engaged in sedentary screen-time
Measured: 3 months
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)
Time parents spend engaged in screen-time
minutes per day that parents engaged in sedentary screen-time
Measured: 3 months
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.
- First posted21 Jun 2019
- Study start1 Sep 2015
- Primary completion1 Sep 2016
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Principal investigator, Natalie Pearson, Loughborough University
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kids FIRST: Development and Feasibility of a Family-based Intervention to Reduce Snacking and Screen Time in Children
- ClinicalTrials.gov ID
- NCT03993652
- Acronym / sponsor ID
- PG/12/70/29777
- Conditions
- Sedentary Lifestyle, Sedentary Behavior, Diet Habit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- 4-arm intervention. 3 interventions that received the same model but tailored to behavioural target. control group received no treatment
| Arm | Type | Receives |
|---|---|---|
| Screen-time and Snacking | Experimental | Behavioral: Kids FIRSTAim: to reduce both screen-time and unhealthy snacking |
| Screen-time only | Experimental | Behavioral: Kids FIRSTAim: to reduce screen-time only |
| Snacking only | Experimental | Behavioral: Kids FIRSTAim: to reduce unhealthy snacking only |
| Control | No intervention | –Control |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The study targeted families with at least one 5-6 and/or 9-11 year old child.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kids FIRSTfamily- and school-based intervention to reduce unhealthy screen-time and snacking | Behavioural | Screen-time and Snacking, Screen-time only, Snacking only |
Primary outcome
Time spent engaged in screen-time
Time frame: 3 months
minutes per week engaged in sedentary screen-time
Frequency of consumption of energy-dense snack foods, fruits and vegetables
Time frame: 3 months
Daily frequency of consumption of energy-dense snack foods
2 secondary outcomes
Time parents spend engaged in screen-time
Time frame: 3 months
parent consumption of energy-dense snacks
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
- Derived from this study: PubMed 31996192Pearson 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.
- Individual participant dataSharing planned: Undecided. Unsure
Related trials for Sedentary Lifestyle
RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Gestational Diabetes, Endothelial Dysfunction
Not yet recruiting
Effects of Different Exercise Types on Irisin, Leptin, and Ghrelin Levels in Sedentary Women
Exercise Physiology, Metabolic Hormones
Active, not recruiting
A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers
Healthy, 24-Hour Movement Guidelines
Recruiting
Acute Endocrine Responses to Aerobic and Anaerobic Exercise in Sedentary Women: A Comparative Analysis of Thyroid Hormones and Cortisol
Sedentary Behavior, Acute Exercise
Not yet recruiting
Wearable Ankle Power Training (WearAPT) for Enhanced Mobility in Aging
Sedentary Behavior / Physical Inactivity, Aged
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.