Formative Evaluation of The HERizon Project

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

Interventions

BEHAVIORAL

HERizon Project

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.

Sponsors & Collaborators

• University of Liverpool

  collaborator OTHER

• Dublin City University

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• Liverpool John Moores University

  lead OTHER

Principal Investigators

• Anton Wagenmakers · Liverpool John Moores University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

13 Years

Max Age

16 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-04-15

Primary Completion

2020-07-08

Completion

2020-07-08

Countries

• Ireland
• United Kingdom

Study Locations