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Table 2 Details of fidelity data collected and analysed in the HeLP cluster RCT

From: Intervention fidelity in the definitive cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP) trial: findings from the process evaluation

Element of fidelity assessed

Method of data collection

Data collected

Number completed

Time of data collection

Personnel collecting data

Intervention uptake (dose/exposure)

Registers

Child attendance for all intervention components and parental attendance for formal parental engagement events and invitations to observe (see Table 1).

21/21 child attendance registers completed for each of the 16 intervention schools for children.

4/4 parental attendance registers completed for each of the 16 intervention schools.

During delivery of each intervention component.

HeLP Coordinator and

Teachers for the literacy lesson in phase 1 and education lessons in phase 2 and 4.

Adherence to intervention components (form)

Observations and completion of checklists

Each component for each phase of the intervention had a number of sub components.

A yes or no was given depending upon whether the subcomponent had been delivered.

100%

(71/71 subcomponents assessed in each of the 16 intervention schools)

During delivery of each intervention component.

HeLP Coordinator

Year 5 teachers (for those components delivered solely by the Year 5 teacher):

• Literacy rap lesson in phase 1

• Education lessons in phase 2 and 4

Quality of intervention delivery (spirit)

Observations and completion of checklists

Quality of delivery and child, parent and teacher response scores (1–10) during delivery of the following components:

• Parent assembly (phase 1),

• Healthy Lifestyles Week (phase 2),

• Parent assembly (phase 3)

• Class delivered assembly (phase 4).

100%

(4/4 components assessed in each of the 16 intervention schools)

128 observations in total

During delivery of the specified intervention component.

Trial Manager (phases 1, 3 and 4)

HeLP Coordinator (phase 2)

Participant responsiveness to the intervention as a whole (engagement)

     

  Quantitative assessment

Observations and completion of field notes

Engagement scores:

School (range 0–9)

Child (range 0–3)

96%

(16/16 schools652/676 children

assessed)

Finalisation of scores were made immediately post intervention

(December 2013/14 for Cohort 1/2).

HeLP Coordinator

  Qualitative assessment

Teacher interviews and child focus groups

Teacher and child experience of participating in HeLP

28 teacher interviews and 35 child focus groups

June/July 2013/14 for Year 5 teacher interviews (following phase 3 of the intervention prior to schools breaking up for the Summer holiday)

Trial Manager

    

Jan-March 2014/15 for child focus groups (when the children were in year 6)

Led by the HeLP Coordinator for that school and facilitated by an additional HeLP Coordinator, who took notes and supported the management of the group.