Clinical trial NCT02432924: Using Combined Instantaneous and Multidimensional Feedback to Support a Change in Physical Activity Behaviour
Official title: The Effect of Using Combined Personalised Instantaneous and Multidimensional Physical Activity Feedback on Motivation and Behaviour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Activity
Cardiovascular Diseases
Type 2 Diabetes Mellitus
Lead sponsor: University of Bath
Sponsor class: OTHER
First posted: 2015-05-04
Enrollment: 57
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in physical activity level (PAL)
timeFrame: baseline, 6 weeks and 12 Weeks
Secondary outcomes:
measure: Motivation for Physical activity
timeFrame: baseline, 6 weeks and 12 Weeks
measure: Need satisfaction
timeFrame: baseline, 6 weeks and 12 Weeks
measure: Habitual physical activity
timeFrame: baseline, 6 weeks and 12 Weeks
measure: Vitality
timeFrame: baseline, 6 weeks and 12 Weeks
measure: QIntervention: Change in cardiovascular disease and type 2 diabetes risk
timeFrame: baseline, 6 weeks and 12 Weeks
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: University of Bath: Department for Health
Study officials:
affiliation: University of Bath
name: Dylan Thompson, PhD
role: STUDY_DIRECTOR
References:
citation: 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.