Formative Evaluation of The HERizon Project
Condition: Physical Activity
Study type: Interventional

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.
    

Detailed description: 
      Design. This physical activity study will be evaluated using a two-arm randomised controlled
      trial with an intervention group and a wait-list control group. Assessments will be conducted
      at baseline and 6 weeks from baseline. Assessments will occur remotely in the participants'
      homes in April/May (baseline) and May/June (end point).

      Recruitment. We aim to recruit 40 participants by convenience sampling through links with
      secondary school teachers, LJMU communications with staff and students, and via social media.
      The participant information sheet will be emailed to all potential participants. The email
      will ask potential participants to read the attached information sheet and they will be
      encouraged to ask the researchers questions. Participants will have up to one week to decide
      if they would like to participate in the study. Online consent forms will be used to obtain
      written informed consent for both the participant and their parent/ guardian. Participants
      will be given a link where they can sign the document online or they can sign a paper form
      and scan a copy back to the researcher. Participants will also be asked to provide verbal
      consent before any phone interviews and to tick a box confirming their consent before
      completing any questionnaires.

      Randomisation. Using a computer-based randomisation tool, participants will be assigned to
      one of the two arms (intervention or wait list control). To make allocation more time
      efficient, randomisation will occur prior to baseline assessment. Once the follow up
      assessment has taken place for the intervention group, the wait-list control participants can
      begin the six-week physical activity programme.

      Intervention. Due to the current COVID-19 pandemic, all aspects of this research project will
      be conducted virtually and adhere to the UK Government advice at the time the intervention
      begins. Assessments will be carried out as self-assessments by the participants in both the
      wait-list control and the intervention group in their own homes at two time points (week 0
      and 6). The goals of this physical activity programme are to 1) inform participants of
      specific behaviours change skills related to adopting and maintaining a physically active
      life during and after the COVID-19 pandemic (e.g. self-monitoring, goal setting and
      overcoming challenges), and 2) increase adolescent girls' habitual physical activity (steps
      per day). To achieve these goals the following elements will be implemented:

        -  Exercise Sessions: Participants will be given the choice of different types of
           home-based virtual exercise videos, e.g. boxercise, dance classes, Pilates, bodyweight
           resistance exercise, Joe Wicks Body Coach YouTube channel, or design their own using a
           home-based exercise booklet with a choice of body weight exercises (booklet attached in
           appendix). Participants will be asked to complete 3 sessions of 30 minutes per week. The
           researcher will host an online group fitness class each week which participants are also
           invited to join. This option is to allow participants to engage in the social elements
           of physical activity but from the comfort of their own homes. It is also thought that
           having a scheduled set time to join a class may increase motivation and improve
           adherence, however this is optional. Participants will have the flexibility to choose
           whatever type of exercise suits their preferences and abilities. Using a printed or
           online template (participant preference), participants are asked to record what activity
           they did, the duration and a reflection of how they found the workout e.g. more
           motivated in the morning, burpees really difficult, enjoy a mix of aerobic and
           resistance training.

        -  Behaviour Change Calls: Weekly by phone call or video conference (at the preference of
           the participant e.g. Skype or Zoom) by a trained Prof Doc psychology candidate.
           Behaviour change support is based on self-determination principles (autonomy, competence
           and relatedness). Each call will be based on a pre-planned session outline and will be
           goal orientated, participant centred and focused on PA. Calls are expected to last 15-20
           minutes per participant.

        -  No Reply SMS: Sent to the participant's mobile phone twice per week by a trained Prof
           Doc psychology candidate from an online messaging software (this option will be used as
           given the current situation researchers cannot access LJMU phones. This service is
           password protected and participants phone numbers will not be stored online). All
           messages will be standardised (not personally tailored) and will be focused on behaviour
           change techniques or reminders.

      Control: Participants in the wait-list control group will receive the physical activity
      programme after follow-up measures have been taken from the intervention group. Participants
      in the control group will only have contact with the research team during data collections
      for the first six week (and then will carry out six weeks with prof doc behaviour change
      support and SMS support). They will then complete all self-assessment measures at week 0 and
      6 (self-report and objective physical activity levels, aerobic capacity, muscular endurance,
      strength/power, PA motivation, self-esteem, body appreciation and PA competence).

      Primary and Secondary Outcomes The assessment of the primary and secondary outcomes will be
      conducted without on-site presence of the participants or researchers at two occasions;
      baseline (week 0) and post-intervention (week 6). Self-reported and objectively assessed PA
      levels of one week , and psychosocial determinants of physical activity will be assessed at
      baseline and post-intervention (week 0 and week 6). At 6 weeks, a sub-group of participants
      will be asked to do phone interviews with the lead researcher to give their feedback on the
      intervention.

      Phone interviews. Interviews will be conducted with a random subsample of 10 participants
      from the intervention group at week 6. Interviews will be conducted via phone call and will
      last approximately 20-30 minutes. Discussion will focus on participants' experience of the
      intervention, suggestions, perceived benefits of the intervention and perceived facilitators
      and barriers (i.e. what worked well, what worked less well). Qualitative measures are vital
      to this study as is it important to collect adolescents' perspectives of data collection
      measures, the method of behaviour change support and the virtual exercise. Through interviews
      we hope to gain a rich insight into their perceived barriers and facilitators to the PA
      programme. By gaining this invaluable knowledge the programme can be further refined for
      future implementation. Considerations have been outlined in regard to what the researcher
      might do in the unlikely event of a child disclosing potentially concerning information.

      Procedures. Written informed consent from participants and parents/guardians will be returned
      to the researcher prior to the commencement of testing. Testing will occur in the
      participants home remotely. It is advised that participants complete the testing, exercise
      sessions and behaviour change support calls in a public area of their home but in private
      e.g. in the sitting room and are not permitted to take any calls from the research team or
      prof doc candidates in their bedrooms. Following written consent, participants will complete
      all questionnaires online (approximately 30 minutes) - self-reported physical activity,
      sociodemographic and psychosocial determinants. Participants will then complete the fitness
      measures using the RTFT app (30 minutes). Participants will monitor their steps using a
      mobile-based app for 7 days before starting their 6-week physical activity programme. In
      total assessments should take approximately one hour and will be conducted at baseline (week
      0) and post-intervention (week 6).

      Each week for six weeks, participants will; (1) complete three 30-minute exercise sessions,
      (2) receive two behaviour change support SMS to their mobile from an LJMU prof doc for six
      weeks, e.g. motivation or reminder texts, (3) have one 15-20-minute call with an LJMU prof
      doc each week for six weeks. This will be done via phone call or video call (at the
      participants' preference) and will focus on behaviour change support, e.g. goal setting and
      overcoming challenges. The exercise options the girls can choose from are based on the
      results of previously conducted focus groups with a different cohort of adolescent girls from
      the UK and Ireland, i.e. their favourite types of activity were home-based, video-led,
      boxing, dancing and a mix of aerobic and resistance exercises. Participants adherence will be
      monitored in two ways, a. written self-reported exercise log and b. during weekly support
      call with prof doc.

      Data Processing and Statistical Analyses. Participants' baseline characteristics will be
      presented as means (standard deviation) for all continuous variables and as percentages for
      categorical variables. Statistical tests, including t-tests, Mann-Whitney tests and Pearson's
      chi-squared or Fisher's exact test will be used, as appropriate, to investigate any
      differences in demographic factors between the two groups. Linear missed models will be used
      to compare groups, time and group x time interaction. Recruitment and retention will also be
      summarised descriptively. Multilevel modelling will be used to assess preliminary
      effectiveness of the intervention on adolescents PA. Statistical analysis of measured
      outcomes will be conducted using the latest edition of SPSS Statistics (SPSS Inc., IBM Corp.,
      Armonk, NY).

      All semi-structured interviews will be audio recorded and transcribed verbatim by the primary
      researcher (when they will then be anonymised). Thematic analysis will be conducted using
      NVivo electronic software to identify common themes and sub-themes (Braun & Clarke, 2002).
    

Intervention name(s): HERizon Project
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Block randomisation with country-level stratification was used using Microsoft Excel to allocate the participants on entry (1:1 ratio to groups)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: physical activity; adolescents; girls; behaviour change; qualitative