Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/11/2013
Date assigned
27/12/2013
Last edited
10/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Rising levels of inactivity and poor diet are important concerns to public health, considering the increased incidence of obesity. While physical activity declines across the life course, this may be accelerated as a result of particular life events. One key point is during adolescence and early adulthood, and it is possible that leaving school (i.e., losing all the opportunities and encouragement for physical activity that school attendance entails), may be a contributor to this. Similarly, young people develop greater control over their diet during late adolescence (e.g., leaving controlled school and home eating environments to go to work), and potentially set down habits for how they will eat over coming years. Young people with low incomes and social resources are at particular risk of developing risky health behaviours (e.g., poor diet and an inactive lifestyle). We see the transition from school to employment to provide an opportunity to change behaviour; this is because it is much easier to break habits when your environment changes than when routines are established. This work will test an intervention to promote and maintain healthy lifestyle habits in young people leaving school for work. Engaging young people in health promoting initiatives is notoriously difficult, so to try and ensure good participation levels we will also test whether incentives can be used to prompt such changes. Findings from this work will provide valuable information to inform policy on the feasibility of health promotion with this under-researched and hard-to-reach group.

Who can participate?
All pupils in their final year of education before taking up employment or work-based learning within participating schools can take part in this study.

What does the study involve?
Students will be recruited to the project before leaving school, and invited to an information session at their local leisure centre. They will be randomly allocated to one of three groups: behavioural support, behavioural support with incentives or information only control group.

What are the possible benefits and risks of participating?
Participants in the intervention groups will benefit from receiving 3 months of free access to their local leisure centre, plus behavioural support to help them to set and reach their own physical activity and dietary goals. Participants in the control group will receive information about healthy lifestyles. There are no obvious risks related to participation.

Where is the study run from?
The study is run from secondary schools in the Bath & North East Somerset (UK) and Wiltshire (UK).

When is the study starting and how long is it expected to run for?
The study began in February 2009 and ran until in June 2011.

Who is funding the study?
National Prevention Research Initiative (NPRI), UK.

Who is the main contact?
Dr. Martyn Standage
M.Standage@bath.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Martyn Standage

ORCID ID

Contact details

Department for Health
University of Bath
Bath
BA2 7AY
United Kingdom
m.standage@bath.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0701878

Study information

Scientific title

The use of incentives in the formation of healthy lifestyle habits following the school to work transition: a cluster randomised controlled trial

Acronym

Study hypothesis

1. The study will test whether a theoretically derived intervention (based on the principles of self-determination theory) can promote the adoption of healthy physical activity and dietary habits in young people leaving school for work.
2. Financial incentives (in the form of 4 x £10 vouchers) contingent on continued attendance at behavioural support sessions (rather than target behavioural outcomes) will promote engagement with the programme; this will foster better outcomes through promoting higher exposure to intervention content.
3. Participant outcomes in terms of health behaviours and well-being will be mediated by increases in their perceptions of an autonomy supportive teaching context, satisfaction of autonomy, competence, relatedness and also by improved levels of autonomous motivation.

Ethics approval

University of Bath, School for Health Research Ethics Approval Panel, March 2009

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

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

Condition

Health Promotion (physical activity and diet)

Intervention

Participants are randomised to one of three groups
1. Three months of behavioural support for promoting a healthy diet and physical activity
2. Three months of behavioural support with incentives (4 x £10 voucher for driving lessons or mobile phone top-ups)
3. An information only control group.

The intervention was developed by a team of experts in motivation, habit theory, and the delivery of behavioural interventions. A full need assessment was conducted through interviewing young people in the target population, and conducting a thorough literature review. The intervention was then systematically constructed through a process of intervention mapping, that is, matching specific evidence-based behaviour change strategies to the specific determinants of behaviour change important in this context. Leisure centre advisors were provided with a half-day training event prior to participation, which included a rationale of the study, and aims within the study, and provided experience of delivering study content in a style that supported participants’ sense of autonomy, and confidence in their ability to take control over their health behaviours. Advisors also received a reference manual to consult following the training, and were provided with ongoing support from the research manager. A participant booklet (one issued for each person allocated) guided advisors and participants through the goal-setting process at each appointment. The focus of the intervention was for participants to set their own personal goals for improving/maintaining their diet and physical activity, and monitor their progress against these goals over a three month period. All costs for leisure centre use were covered during the study period, and participants in the intervention arm of the trial received £10 vouchers for continued attendance. At the end of the trial, advisors discussed long-term goals with participants, and facilitated the process of extending membership, or seeking other ways of achieving these goals locally.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Objectively assessed moderate-vigorous physical activity (MVPA), assessed using Actigraph GT1M accerlerometers
2. Diet quality, assessed using a European Food Frequency questionnaire

Outcomes measured at baseline, 12 weeks, and 52 weeks.

Secondary outcome measures

1. Weight and height (to provide Body Mass Index scores)
2. Motivation towards exercise (BREQ-2)
3. Perceived autonomy support for exercise (from study personnel)
4. Strength of habits for physical activity
5. Strength of habits for dietary intake

Outcomes measured at baseline, 12 weeks, and 52 weeks.

Overall trial start date

01/05/2009

Overall trial end date

01/09/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Students in participating schools who are in their final year of study before leaving school for work or work-based learning.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

350

Participant exclusion criteria

Students in participating schools leaving school for higher education, or further study (not work-based).

Recruitment start date

01/05/2009

Recruitment end date

01/09/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department for Health
Bath
BA2 7AY
United Kingdom

Sponsor information

Organisation

University of Bath (UK)

Sponsor details

c/o Lisa Austin
Department for Health
Bath
BA2 7AY
United Kingdom
L.Austin@bath.ac.uk

Sponsor type

University/education

Website

http://www.bath.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) - National Prevention Research Initiative (NPRI) (UK) Ref: G0701878

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24592967

Publication citations

  1. Protocol

    Gillison F, Standage M, Verplanken B, A cluster randomised controlled trial of an intervention to promote healthy lifestyle habits to school leavers: study rationale, design, and methods., BMC Public Health, 2014, 14, 221, doi: 10.1186/1471-2458-14-221.

Additional files

Editorial Notes