NCT02963805

Brief Summary

The purpose of the A-CLASS project was to measure the effect of the 4 hour offer on children's physical activity, health and physical competence.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
Last Updated

December 8, 2016

Status Verified

December 1, 2016

Enrollment Period

3.2 years

First QC Date

November 10, 2016

Last Update Submit

December 7, 2016

Conditions

Keywords

ChildrenPhysical activityPhysical competenceObesitySchoolHealthFundamental movement skills

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in total skills score at end intervention (9 months) and follow up (3 years)

    8 fundamental movement skills were assessed (vertical jump, sprint run, hop, dodge (locomotor) kick, catch, overarm throw, strike (object-control). Assessments were conducted in the school playground or gym (weather dependent) by one researcher with the same equipment at each site. Children were given a verbal description and single demonstration of the skill. Children performed each skill 5 times (3 for the sprint run and dodge) in a standardised order. Recordings of all participants were taken from identical angles and distances using a tripod mounted video camera. Skills were assessed by video analysis using process-orientated measures. If the skill component was present on 4 out of 5 trials (2 out of 3 for sprint run and dodge) the child was marked as possessing that skill component. The number of skill components checked as present in each of the 8 skills was summed to create an overall skill score (max score 48) for use in the analysis.

    Baseline (month 0), End-intervention (9 months), Follow-up (3 years)

Secondary Outcomes (47)

  • Change from baseline in body mass index at end intervention (9 months) and follow up (3 years)

    Baseline (month 0), End-intervention (9 months), Follow-up (3 years)

  • Change from baseline in bone mineral content of the total body at end intervention (9 months) and follow up (3 years)

    Baseline (month 0), End-intervention (9 months), Follow-up (3 years)

  • Change from baseline in bone areal density of the total body at end intervention (9 months) and follow up (3 years)

    Baseline (month 0), End-intervention (9 months), Follow-up (3 years)

  • Change from baseline in bone mineral content of the femoral neck at end intervention (9 months) and follow up (3 years)

    Baseline (month 0), End-intervention (9 months), Follow-up (3 years)

  • Change from baseline in bone areal density of the femoral neck at end intervention (9 months) and follow up (3 years)

    Baseline (month 0), End-intervention (9 months), Follow-up (3 years)

  • +42 more secondary outcomes

Study Arms (4)

High intensity physical activity (HIPA)

EXPERIMENTAL

Participants attended high intensity vigorous activity after school clubs.

Behavioral: High intensity physical activity (HIPA)

Fundamental movement skill (FMS)

EXPERIMENTAL

Participants attended fundamental movement skill based after school clubs.

Behavioral: Fundamental movement skill (FMS)

Physical activity signposting (PASS)

EXPERIMENTAL

Participants attended educational physical activity signposting sessions during school hours.

Behavioral: Physical activity signposting (PASS)

Control

NO INTERVENTION

Children in the control group received British Heart Foundation leaflets that included information on heart health (given to all groups). Children participated in their usual school curriculum including two hours of physical education and school sport per week, both within and beyond the curriculum.

Interventions

This arm consisted of a twice-weekly after-school club at the intervention school for 26 weeks during school term time, delivered by qualified coaches. Each 60 minute session engaged participants in high-intensity vigorous activity using a combination of playground-style games and circuit training activities that aimed to keep children moving and maintain a mean heart rate above 70% of age-predicted maximum heart rate (\~145 beats/min) for the session duration. Intensity was verified by heart rate monitoring. Coaches delivered and monitored sessions and increased the intensity over time to allow for the children to progress. The mean heart rate for HIPA sessions was 150 beats/min, with children spending 52 min at this intensity during the session.

High intensity physical activity (HIPA)

This arm consisted of a twice-weekly after-school club at the intervention school for 26 weeks during school term time, delivered by qualified coaches. Each 60 minute session focused on improving two skills from the vertical jump, hop, sprint run, dodge, kick, catch, overarm throw, and strike. All skills were taught in equal quantities. Each session was designed to maximise participation and enjoyment, and consisted of various games, drills, self-learning activities, and offered numerous opportunities for practice. Skill components were taught to the children using simple learning cues, and skill related questions were used to develop purposeful feedback. The mean heart rate for FMS sessions was recorded at 141 beats/min, with children spending 55 min at this intensity during the session.

Fundamental movement skill (FMS)

A researcher visited participants once per week in 6 weekly blocks to set an activity mission to complete outside school with family and friends. Twenty missions were set over 4 x 6 week blocks, each separated by a 6 week break. Each mission suggests a task as a prompt to participate in physical activity and decrease sedentariness during the week. Children received a sticker on a wall chart for returning the mission; children were rewarded with prizes if all missions were returned in each block. If all missions were returned in a block, a reward was given. 58% of children returned all twenty missions. In addition to the missions, pedometers were issued as a promotional tool for the duration of the project for self-monitoring of activity.

Physical activity signposting (PASS)

Eligibility Criteria

Age9 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • a. body mass index (BMI) score within the lower 50th percentile relative to children in their year at their school.

You may not qualify if:

  • family history of sudden death.
  • presence of chronic disease, metabolic disorders, motor or co-ordination difficulties
  • prescribed medications including steroids inhaled by asthma sufferers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • McWhannell N, Foweather L, Graves LEF, Henaghan JL, Ridgers ND, Stratton G. From Surveillance to Intervention: Overview and Baseline Findings for the Active City of Liverpool Active Schools and SportsLinx (A-CLASS) Project. Int J Environ Res Public Health. 2018 Mar 23;15(4):582. doi: 10.3390/ijerph15040582.

MeSH Terms

Conditions

Motor ActivityHealth BehaviorObesity

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gareth Stratton, PhD

    Swansea University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 10, 2016

First Posted

November 15, 2016

Study Start

September 1, 2006

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

December 8, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share