Formative Evaluation of The HERizon Project

NCT04662775 | Completed

• 1 other identifier: HERizonProject
• Study Type: interventional
• Target: 42
• Locations: 2 countries
• Sites: 3

Brief Summary

This mixed methods study was the feasibility phase of a broader intervention of research (The HERizon Project) that aims to develop a theory-based physical activity intervention targeting adolescent girls in the UK and Ireland. The design was a two-arm randomised controlled trial, comprising of (i) the HERizon six week remote intervention arm and (ii) a wait-list control arm. Block randomisation with country-level stratification was used to allocate the participants on entry. The primary outcome of the study was change in moderate to vigorous physical activity levels. Secondary outcomes included cardiorespiratory fitness, muscular strength and endurance, exercise motivation, perceived competence, self-esteem and body appreciation. Assessments were conducted pre-intervention (April/May, 2020) and repeated immediately post-intervention (June/July, 2020). As the study ran during the COVID-19 pandemic, all participants began the intervention in full national lockdowns, with all local schools and amenities being closed. Restriction began to be lifted in the last week of June in Ireland and in the first week of July in the UK, with some local amenities opening and small outside group gathering being permitted. Due to the nature of the study, participants and project deliverers could not be blinded to the assigned intervention.

Conditions

Physical Activity

Keywords

physical activity; adolescents; girls; behaviour change; qualitative

Outcome Measures

Primary Outcomes (1)

• Physical activity

  Moderate to vigorous physical activity was assessed using the 8-item sub-scale World Health Organisation Health Behaviours of School Children questionnaire which has been validated with adolescents. This was used to collect self-reported physical activity over the previous seven-day period at baseline and post-intervention. Girls self-reported the estimated hours they spent engaging in physical activity before school, during school, after school and at weekends. The total hours spent in moderate to vigorous physical activity were then averaged across the week to find daily averages. The government guidelines are 60 minutes per day of physical activity on average across the week.

  6 weeks

Secondary Outcomes (9)

• Cardiorespiratory fitness

  6 weeks

• Muscular endurance

  6 weeks

• Muscular strength

  6 weeks

• Exercise motivation

  6 weeks

• Body image

  6 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

This group received the multi-component physical activity intervention (physical activity programme, weekly behaviour change support calls, non-reply text messages)

Behavioral: HERizon Project

Waitlist control

NO INTERVENTION

Participants in the wait-list control group were asked to continue their usual PA habits and received no additional contact from the research team outside of data collection points. Following post-intervention data collection, control group participants were invited to participate in the same intervention as described above.

Interventions

HERizon Project BEHAVIORAL

1\. Participants were asked to complete 3x30-minute physical activity sessions each week \& record their sessions using a logbook. They were given the choice of different types of home-based virtual exercise. 2. Behaviour change support calls - participants were allocated an "Activity Mentor" (trainee sport and exercise psychologists, was supervised by a HCPC-registered Psychologist). Participants had seven weekly videocalls. Each call was based on a pre-planned session outline and was goal orientated, participant centred and focused on physical activity. 3. No reply SMS - Participants received 3 standardised text messages each week, aimed at providing physical activity -related facts, encouragement and study information.

Intervention group

Eligibility Criteria

• Age: 13 Years - 16 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Female
• years
• Living in the UK and Ireland
• Ability to participate in moderate intensity physical activity according to the Physical Activity Readiness Questionnaire

You may not qualify if:

• Currently pregnant
• Severe psychological or neurological condition
• No access to a phone or computer

Sponsors & Collaborators

• Liverpool John Moores University: lead
• University of Liverpool: collaborator
• Dublin City University: collaborator
• Radboud University Medical Center: collaborator

Study Sites (3)

Dublin City University

Dublin, Ireland

Location

LiverpoolJMU

Liverpool, Merseyside, L3 5AF, United Kingdom

Location

Wolfson Centre for Personalised Medicine, Institute of Systems, Molecular and Integrative Biology

Liverpool, United Kingdom

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Anton Wagenmakers

  Liverpool John Moores University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Block randomisation with country-level stratification was used using Microsoft Excel to allocate the participants on entry (1:1 ratio to groups)

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 10, 2020
• Study Start: April 15, 2020
• Primary Completion: July 8, 2020
• Study Completion: July 8, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); IE (1)