- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02432924
Using Combined Instantaneous and Multidimensional Feedback to Support a Change in Physical Activity Behaviour
The Effect of Using Combined Personalised Instantaneous and Multidimensional Physical Activity Feedback on Motivation and Behaviour
Study Overview
Status
Intervention / Treatment
Detailed Description
Advancements in monitoring technology not only permit the accurate capture of sophisticated physical activity information but also enable the provision of bespoke multidimensional feedback. Personalised feedback, self-monitoring and goal-setting are techniques that have been shown to be very effective in supporting a change in behaviour through improved motivation and awareness. To date the feedback provided in physical activity interventions invariably focuses on just one aspect of the behaviour and has had mixed results. Pedometers for example with a sole focus on the number of steps one takes has been shown to be a reasonably effective form of instant feedback in the short-term but its effects are rarely sustained after the device is removed. Tailored information about the achievement of 30 minutes of moderate to vigorous intensity activity is also only partially effective. One of the reasons might be that in focusing on just one aspect becomes prescriptive and doesn't allow individuals to explore the other important aspects that might be more aligned to their interests, needs and preferences. Having such narrow focused goals and information would likely frustrate rather than support an individual's needs for autonomy and competence, which is thought to be crucial in the adoption and maintenance of a new behaviour.
In this research, we want to find out whether the provision of both instantaneous and multidimensional personalised feedback about the different health-harnessing aspects of physical activity is effective in supporting adults in making a meaningful change to their physical activity behaviour. The study will take a mixed methods approach which will involve two phases. Phase 1 will involve a 2 group randomised control trial that will examine the use of combined instantaneous and multidimensional feedback over a 6-week period with a further follow-up outcome assessment a further 6-weeks after the intervention has finished. The second phase will involve a short one-to-one semi structured interview with each intervention participant that will be designed to qualitatively explore the preferred features of the intervention that were most effective for motivating and supporting a change in behaviour and/or to understand why it wasn't effective if applicable. The qualitative interviews will take place after the 6-week follow-up assessments have been completed so not to influence the results of any outcome measures.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bath, United Kingdom, BA2 7AY
- University of Bath: Department for Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged between 40-70 years inclusive
- Able to give informed consent to participate in the study
Exclusion Criteria:
- Diagnosed with coronary heart disease, chronic kidney disease (CKD stages 3-5), type 2 diabetes, stroke, heart failure and peripheral arterial disease
- Those with 'severe hypertension' defined as a BP greater than 180/110 mmHg.
- A BMI >40 kg/m2
- Use of weight loss drugs.
- A large recent (i.e. last 6 months) shift (>5%) in body mass or change in lifestyle.
- Those unable to change their physical activity (e.g. through disability or illness).
- Individuals who already lead highly physically active lifestyles (PAL > 2.0)
- Individuals who are not fluent in the English language.
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Feedback Group
Participants randomised into the intervention group will be invited to return to the university for a one-off 60 minute set-up session once their physical activity monitor has been returned and processed.
Within this session the participant will be given detailed instructions on how to use and wear the activity monitor and real time display and upload their data to and navigate the multidimensional feedback web platform (See materials section for details).
They will also be introduced to the concept of goal setting and talked through the different aspects of the instantaneous feedback display and how that might benefit them.
Following this visit the participant will be given licence to wear and use the physical activity monitoring devices for a 6-week period and encouraged to self-monitor their behaviour using the combined instantaneous and multidimensional feedback.
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Other Names:
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No Intervention: Waiting List Control Group
Participants who have been randomised into the control arm will be put on a 3 month waiting list to receive the intervention described above.
They will still attend assessment visits at week 6 and week 12 while they are not receiving any advice or feedback.
Following their 12 week assessment, participants in the control arm will be invited to attend the same 60 minute set-up session as received by the intervention group and then provided with the armband monitor and display to then receive the intervention in full.
No further post-intervention or follow-up assessments will be taken from these participants.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in physical activity level (PAL)
Time Frame: baseline, 6 weeks and 12 Weeks
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Mean physical activity level (PAL) as calculated using the formula average daily total energy expenditure/basal metabolic rate (Kcal).
Minute by minute energy expenditure (TEE) will be objective measured using the SenseWear Armband (Bodymedia, software version 8.0).
For assessment, monitors will be initialised with each individual's personal information (age, gender, height, and weight) and participants will be advised on how to fit and wear the devices.
Participants will be asked to wear the monitor(s) for 7 days (including while sleeping) and will be asked to remove the monitors briefly for showers or water activities.
As well as PAL the energy expenditure assessment will be used to determine total and average daily minutes of light intensity activity (greater than 1.5METs) moderate intensity activity (greater than 3METs); vigorous intensity activity (greater than 6 METs), accumulated moderate to vigorous activity bouts of 10 minutes and daily sedentary time.
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baseline, 6 weeks and 12 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Motivation for Physical activity
Time Frame: baseline, 6 weeks and 12 Weeks
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Motivation for physical activity will be assessed using an adapted version of the behavioural regulations for exercise questionnaire (BREQ-2, Markland and Tobin, 2004).
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baseline, 6 weeks and 12 Weeks
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Need satisfaction
Time Frame: baseline, 6 weeks and 12 Weeks
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Need satisfaction during physical activity will be measured by psychological need satisfaction in exercise (PNSE, Wilson et al., 2006).
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baseline, 6 weeks and 12 Weeks
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Habitual physical activity
Time Frame: baseline, 6 weeks and 12 Weeks
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Habitual physical activity will be measured using the self-reported habit index (SRHI, Verplanken and Orbell, 2003).
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baseline, 6 weeks and 12 Weeks
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Vitality
Time Frame: baseline, 6 weeks and 12 Weeks
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Vitality and quality of life will be assessed using the Subjective vitality index and Quality of life (SF-36, EQ-51) scales.
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baseline, 6 weeks and 12 Weeks
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QIntervention: Change in cardiovascular disease and type 2 diabetes risk
Time Frame: baseline, 6 weeks and 12 Weeks
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Risk of Type 2 Diabetes and Cardiovascular disease will be calculated at http://qintervention.org/ and be ascertained from measurements of glucose and insulin control, C-Reactive Protein, fasting lipid profile (HDL:LDL ratio; total cholesterol and triglyceride) in the blood and height, weight, waist circumference, smoking status, blood pressure and familial history of CVD or diabetes.
All of these measurements will be collected at the 3 assessment time points.
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baseline, 6 weeks and 12 Weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Dylan Thompson, PhD, University of Bath
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EP-14/15-10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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