Condition category
Not Applicable
Date applied
26/02/2018
Date assigned
16/03/2018
Last edited
15/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The training of practitioners and undergraduate students of the health professions in communication skills to support lifestyle behavioural change related to chronic disease prevention and management is a national priority for Ireland’s Health Service and higher education institutions. An e-learning training programme in behavioural change skills related to self-management behaviours for chronic musculoskeletal pain (E-SOLAS) has been developed by the interdisciplinary UCD research team and shown to be acceptable to physiotherapists and effective in guiding delivery of a group-based intervention for clients with chronic musculoskeletal pain with high fidelity using a needs supportive communication style underpinned by self-determination theory. The behavioural change skills component of the E-SOLAS training programme has potential for integration into the education programmes of health professional students beyond physiotherapy. The original E-SOLAS training programme was adapted for students of clinical nutrition and dietetics who currently receive four hours face-to-face training in behavioural change skills. The aims of this study are to explore the effects of the E-SOLAS behaviour change skills training programme to prepare students in Human Nutrition and Dietetics to develop knowledge, confidence and skills in needs supportive communication to support behavioural change, as well as any necessary modifications to improve the acceptability and appropriateness of this e-learning training programme for application to UCD students.

Who can participate?
Students registered on the MSc Clinical Nutrition and Dietetics programme at University College Dublin

What does the study involve?
Participants are randomly allocated to one of two groups. One group receives E-SOLAS behaviour change skills training and the usual face-to-face behavioural change skills training. The other group receives the usual face-to-face behavioural change skills training only. On completion of the study each participant is invited to complete a questionnaire and submit an audio-recording of their practice of behaviour change skills for rating by two members of the research team.

What are the possible benefits and risks of participating?
Participants receive training to support their learning of behavioural change skills and provide feedback on the training programme to improve its acceptability and effectiveness for students in health professional programmes. There are no risks involved in participating in this study.

Where is the study run from?
University College Dublin (Ireland)

When is the study starting and how long is it expected to run for?
January 2018 to June 2018

Who is funding the study?
University College Dublin (Ireland)

Who is the main contact?
Prof. Deirdre Hurley
deirdre.hurleyosing@ucd.ie

Trial website

Contact information

Type

Scientific

Primary contact

Prof Deirdre Hurley

ORCID ID

Contact details

Room A102
Health Sciences Centre
University College Dublin
Belfield
Dublin
D4
Ireland
+353 (0)17166524
deirdre.hurleyosing@ucd.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LS-E-18-23-Hurley

Study information

Scientific title

Evaluation of theory-driven behavioural change skills training in clinical nutrition and dietetics students: a pilot trial comparing blended learning and face-to-face educational approaches

Acronym

Study hypothesis

1. Blended learning will have larger effects on participants' knowledge, self-efficacy and skills (competence) in the use of behavioural change skills than face-to-face training only
2. There will be comparable levels of student satisfaction with the education provided

Ethics approval

University College Dublin, Human Research Ethics Committee - Sciences (HREC-LS), 31/01/2018, ref: LS-E-18-23-Hurley

Study design

Single-centre pilot randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Education of pre-registration students in clinical nutrition and dietetics in behavioural change skills

Intervention

Consenting participants (i.e. students registered on the MSc Clinical Nutrition and Dietetics programme) will be randomly allocated to the experimental arm (usual face-to-face behavioural change skills training + E-learning behaviour change skills training; n=10) or the control arm (usual face-to-face behavioural change skills training only; n=10). Following provision of written, informed consent and completion of the baseline questionnaires all participants will be randomized. Concealed randomization will be conducted by the Principal Investigator using a random numbers table.

Experimental arm: 4 hours Group-Based Face-to-Face Training + Individual E-learning Training in Behavioural Change Skills
Control arm: 4 hours Group-Based Face-to-Face Training in Behavioural Change Skills

All participants will receive usual face-to-face training in behavioural change skills and in addition, experimental arm participants will be given access to the E-SOLAS training programme to complete independently over a 4-week period. On completion of the study each participant will be invited to complete the post-training questionnaire and submit an audio-recording of their practice of behaviour change skills for blinded rating by two members of the research team.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Measured at baseline and post-training:
1. Knowledge of Self-Determination Theory (SDT) strategies will be assessed by students narratively describing how they would work to motivate a disengaged client case study that will be coded by a blinded expert rater
2. Confidence (self-efficacy) in the use of the above SDT behavioural change strategies will be assessed using a researcher devised questionnaire (10 items, 7-point Likert Scale)
3. Competence in applying the above SDT behavioural change strategies will be assessed by each student audio-recording a role play with a colleague that will involve each participants use of the SDT strategies to support the 'client' to change their behaviour related to healthy eating, which will be rated by a blinded expert rater

Secondary outcome measures

Satisfaction and acceptability of each educational training programme will be assessed using a researcher devised questionnaire (5-point Likert Scale) post training

Overall trial start date

26/01/2018

Overall trial end date

30/06/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Students registered on the MSc Clinical Nutrition and Dietetics programme at University College Dublin

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

Students registered on any other programme at University College Dublin

Recruitment start date

08/02/2018

Recruitment end date

27/02/2018

Locations

Countries of recruitment

Ireland

Trial participating centre

University College Dublin
School of Public Health, Physiotherapy and Sports Science Health Sciences Centre Belfield
Dublin
D4
Ireland

Sponsor information

Organisation

University College Dublin

Sponsor details

School of Public Health
Physiotherapy and Sports Science
Belfield
Dublin
D4
Ireland
+353 (0)17166524
deirdre.hurleyosing@ucd.ie

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University College Dublin

Alternative name(s)

UCD

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Ireland

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal one year after trial end date.

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

30/06/2019

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes