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临床试验/NCT03993652
NCT03993652已完成不适用

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

Loughborough University0 个研究点目标入组 75 人开始时间: 2015年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
75
主要终点
Time spent engaged in screen-time

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

盲法说明

schools were blinded to study arm

入排标准

年龄范围
5 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

Screen-time and Snacking

Experimental

Aim: to reduce both screen-time and unhealthy snacking

干预措施: Kids FIRST (Behavioral)

Control

No Intervention

Control

Snacking only

Experimental

Aim: to reduce unhealthy snacking only

干预措施: Kids FIRST (Behavioral)

Screen-time only

Experimental

Aim: to reduce screen-time only

干预措施: Kids FIRST (Behavioral)

结局指标

主要结局

Time spent engaged in screen-time

时间窗: 3 months

minutes per week engaged in sedentary screen-time

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

时间窗: 3 months

Daily frequency of consumption of energy-dense snack foods

次要结局

  • Time parents spend engaged in screen-time(3 months)
  • parent consumption of energy-dense snacks(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Natalie Pearson

Senior Research Associate in Physical Activity and Public Health

Loughborough University

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