Motor ActivityNCT02432924
Using Combined Instantaneous and Multidimensional Feedback to Support a Change in Physical Activity Behaviour
A study testing Instant + Multidimensional Physical Activity Feedback in people with Motor Activity and Cardiovascular Diseases, run by University of Bath at 1 site in United Kingdom.
Trial summary
The primary aim of the study is to examine whether the provision of personalised multidimensional physical activity profiles (derived from technological advances in physical activity monitoring) is supported by instantaneous physical activity feedback in fostering a meaningful change in physical activity behaviour… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Activity, Cardiovascular Diseases, Type 2 Diabetes Mellitus
- What is being tested?
- Instant + Multidimensional Physical Activity Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 40-70 years inclusive
- Able to give informed consent to participate in the study
Who cannot join
- 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).
Show all 9Show fewer
- Individuals who already lead highly physically active lifestyles (PAL > 2.0)
- Individuals who are not fluent in the English language.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Bath: Department for Health
Bath, BA2 7AY
About this study
Official title: The Effect of Using Combined Personalised Instantaneous and Multidimensional Physical Activity Feedback on Motivation and Behaviour
The primary aim of the study is to examine whether the provision of personalised multidimensional physical activity profiles (derived from technological advances in physical activity monitoring) is supported by instantaneous physical activity feedback in fostering a meaningful change in physical activity behaviour amongst adults.
Read the 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.
- Being tested
- Instant + Multidimensional Physical Activity Feedback
- Medical subject headings
- Motor Activity, Cardiovascular Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instant + Multidimensional Physical Activity FeedbackBehavioural
Also called Bodymedia
| Study group | Role | What they receive |
|---|---|---|
| Feedback Group | Experimental | 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. Receives: Behavioral: Instant + Multidimensional Physical Activity Feedback |
| Waiting List Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity level (PAL)
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.
Measured: baseline, 6 weeks and 12 Weeks
Secondary outcomes (5)
Motivation for Physical activity
Motivation for physical activity will be assessed using an adapted version of the behavioural regulations for exercise questionnaire (BREQ-2, Markland and Tobin, 2004).
Measured: baseline, 6 weeks and 12 Weeks
Need satisfaction
Need satisfaction during physical activity will be measured by psychological need satisfaction in exercise (PNSE, Wilson et al., 2006).
Measured: baseline, 6 weeks and 12 Weeks
Habitual physical activity
Habitual physical activity will be measured using the self-reported habit index (SRHI, Verplanken and Orbell, 2003).
Measured: baseline, 6 weeks and 12 Weeks
Vitality
Vitality and quality of life will be assessed using the Subjective vitality index and Quality of life (SF-36, EQ-51) scales.
Measured: baseline, 6 weeks and 12 Weeks
QIntervention: Change in cardiovascular disease and type 2 diabetes risk
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.
Measured: baseline, 6 weeks and 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startOct 2014
- Primary completionSep 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Motor ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Western, University of Bath
- Investigators
- Dylan Thompson, PhD, Study director, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432924
- Sponsor's protocol ID
- EP-14/15-10
- Status last verified
- Nov 2015
- First submitted
- 23 Apr 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Western MJ, Standage M, Peacock OJ, Nightingale T, Thompson D. Supporting Behavior Change in Sedentary Adults via Real-time Multidimensional Physical Activity Feedback: Mixed Methods Randomized Controlled Trial. JMIR Form Res. 2022 Mar 2;6(3):e26525. doi: 10.2196/26525.
PubMed 35234658
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Combined Personalised Instantaneous and Multidimensional Physical Activity Feedback on Motivation and Behaviour
- ClinicalTrials.gov ID
- NCT02432924
- Acronym / sponsor ID
- EP-14/15-10
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of the study is to examine whether the provision of personalised multidimensional physical activity profiles (derived from technological advances in physical activity monitoring) is supported by instantaneous physical activity feedback in fostering a meaningful change in physical activity behaviour amongst adults.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feedback Group | Experimental | Behavioral: Instant + Multidimensional Physical Activity FeedbackParticipants 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. |
| Waiting List Control Group | No intervention | –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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged between 40-70 years inclusive
- Able to give informed consent to participate in the study
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instant + Multidimensional Physical Activity FeedbackAlso: Bodymedia | Behavioural | Feedback Group |
Primary outcome
Change in physical activity level (PAL)
Time frame: baseline, 6 weeks and 12 Weeks
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.
5 secondary outcomes
Motivation for Physical activity
Time frame: baseline, 6 weeks and 12 Weeks
Need satisfaction
Time frame: baseline, 6 weeks and 12 Weeks
Habitual physical activity
Time frame: baseline, 6 weeks and 12 Weeks
Vitality
Time frame: baseline, 6 weeks and 12 Weeks
QIntervention: Change in cardiovascular disease and type 2 diabetes risk
Time frame: baseline, 6 weeks and 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Derived from this study: PubMed 35234658Western MJ, Standage M, Peacock OJ, Nightingale T, Thompson D. Supporting Behavior Change in Sedentary Adults via Real-time Multidimensional Physical Activity Feedback: Mixed Methods Randomized Controlled Trial. JMIR Form Res. 2022 Mar 2;6(3):e26525. doi: 10.2196/26525.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dylan Thompson, PhD study director
University of Bath
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instant + Multidimensional Physical Activity Feedback in people with Motor Activity and Cardiovascular Diseases, run by University of Bath at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical activity level (PAL) (time frame: baseline, 6 weeks and 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02432924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.