A Multi-component Physical Activity Intervention for Adolescent Girls

NCT04766372 | Unknown

• 1 other identifier: HERizonProject2
• Study Type: interventional
• Target: 160
• Locations: 2 countries
• Sites: 3

Brief Summary

A four-arm randomised pilot trial involving:

• Who the intervention reaches, how representative they are for the population (Reach, Adoption) and who is most likely to benefit from the intervention (Reach);
• The extent to which the intervention is delivered as intended (Implementation), and factors that affect this (Adoption);
• Preliminary impact on participants' PA, sedentary behaviour, cardiovascular fitness and psychological wellbeing at 3, 6 and 12 months (Effectiveness, Maintenance);
• The qualitatively examine the acceptability of the intervention for adolescent girls, and identify necessary refinements;
• To gather data to inform a sample size calculation for a main trail

Conditions

Exercise

Keywords

physical activity; adolescent girls; feasibility; behaviour change

Outcome Measures

Primary Outcomes (1)

• Change in objective physical activity levels

  Participants objective PA will be monitored continuously (i.e. 24 h/day) over a nine-day period using an accelerometer (actigraph GT9x software). This device will be worn on their non-dominant wrist and uses the same validated MEMS sensor as the Actigraph GT3X+ model which has been validated (Hanggi et al., 2013) and used extensively with adolescents (Corder et al., 2016). Using the Actigraph, total daily PA, moderate-to-vigorous PA and sedentary time can be assessed.

  Baseline to post-intervention (week 12)

Secondary Outcomes (8)

• Aerobic capacity

  week 0, week 12, week 24

• Upper body strength

  week 0, week 12, week 24

• Strength/ Power

  week 0, week 12, week 24

• Change in Physical Activity Motivation

  week 0, week 12, week 24

• Change in Body Appreciation

  week 0, week 12, week 24

Other Outcomes (1)

• Process Evaluation

  week 0, week 12, week 24

Study Arms (4)

Menu of physical activity options

EXPERIMENTAL

Participants in all 4 groups will receive this booklet with suggestions of ways to be physically active, e.g. YouTube workouts, cycling or jogging, sports, or design their own using a home-based exercise booklet. Participants are asked to do 3 exercise sessions of 30 minutes per week. Participants are asked to record what activity they did and the duration of the session using a method most convenient for them, e.g. notes on their phone, wall calendar or using an activity log template which we will provide. .

Other: Behaviour change

Physical activity programme

EXPERIMENTAL

Participants in the second group with receive the activity menu (as described above) as well as a detailed physical activity programme. This programme includes supportive weekly text messages, access to live workouts and access to an online social community.

Other: Behaviour change

Individual behaviour change support

EXPERIMENTAL

Participants in the third group with receive the activity menu (as described above) as well as individual behaviour change support. Each participant is partnered with a trainee sport psychology ("Activity Mentor") who they have weekly video calls with to support their health behaviour change.

Other: Behaviour change

Activity Programme & Behaviour Change Support

EXPERIMENTAL

Participants in the fourth group will receive all of the above (exercise menu, live workouts, social community, support texts and weekly calls with an Activity Mentor).

Other: Behaviour change

Interventions

Behaviour change OTHER

Using needs supportive, self-determination theory-based, components to improve the physical activity behaviours of adolescent girls.

Activity Programme & Behaviour Change Support; Individual behaviour change support; Menu of physical activity options; Physical activity programme

Eligibility Criteria

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

You may qualify if:

• Female
• years
• Living in the UK or Ireland
• Would like support with becoming more physically active
• Ability to participate in moderate intensity physical activity according to the Physical Activity Readiness Questionnaire

You may not qualify if:

• Have taken part in previous HERizon study
• Currently doing more than 1 hour of exercise or sport every day.
• Currently pregnant
• Not having access to at least ONE of the following: a smartphone, home computer, or parent smartphone.

Sponsors & Collaborators

• Liverpool John Moores University: lead
• Dublin City University: collaborator
• University of Liverpool: collaborator

Study Sites (3)

Dublin City University

Dublin, Ireland

Location

Liverpool John Moores University

Liverpool, Merseyside, L3 5AF, United Kingdom

Location

University of Liverpool

Liverpool, United Kingdom

Location

Related Publications (2)

• Cowley ES, Watson PM, Foweather L, Belton S, Thompson A, Thijssen D, Wagenmakers AJM. "Girls Aren't Meant to Exercise": Perceived Influences on Physical Activity among Adolescent Girls-The HERizon Project. Children (Basel). 2021 Jan 7;8(1):31. doi: 10.3390/children8010031.

  PMID: 33430413 BACKGROUND

• Cowley ES, Watson PM, Foweather L, Belton S, Mansfield C, Whitcomb-Khan G, Cacciatore I, Thompson A, Thijssen D, Wagenmakers AJM. Formative Evaluation of a Home-Based Physical Activity Intervention for Adolescent Girls-The HERizon Project: A Randomised Controlled Trial. Children (Basel). 2021 Jan 22;8(2):76. doi: 10.3390/children8020076.

  PMID: 33499174 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Anton Wagenmakers, PhD

  Liverpool John Moores University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the study, it will not be possible to blind participants to their study condition (as they will know whether they are engaging the physical activity programme or not). As the researchers will be doing the data collection and conducting the behaviour change support calls, it will also not be possible to blind the researcher to the study.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Using block randomisation on Microsoft Excel, participants will be assigned to one of the four groups following baseline measures

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 23, 2021
• Study Start: November 30, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); IE (1)