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A Multi-component Physical Activity Intervention for Adolescent Girls

NCT04766372 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-02-23

No results posted yet for this study

Summary

A four-arm randomised pilot trial involving:

1. Physical activity programme only - live exercise sessions, social support, standardised text messages
2. Individual behaviour change support only - regular one-to-one video calls with an activity mentor
3. Combined - Physical activity provision and individual behaviour change support
4. Usual care control All groups will be provided with a menu of physical activities.

Objectives.

To conduct a RE-AIM evaluation of a 6-month multi-component PA intervention for adolescent girls, through investigating:

* 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

Interventions

OTHER

Behaviour change

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

Sponsors & Collaborators

  • Dublin City University

    collaborator OTHER

  • University of Liverpool

    collaborator OTHER

  • Liverpool John Moores University

    lead OTHER

Principal Investigators

  • Anton Wagenmakers, PhD · Liverpool John Moores University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • Ireland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04766372 on ClinicalTrials.gov