Using Combined Instantaneous and Multidimensional Feedback to Support a Change in Physical Activity Behaviour

Cardiovascular Diseases Clinical Trial

Official title:

The Effect of Using Combined Personalised Instantaneous and Multidimensional Physical Activity Feedback on Motivation and Behaviour

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02432924
• Other study ID #: EP-14/15-10
• Status: Completed
• Phase: N/A
• First received: April 23, 2015
• Last updated: November 18, 2015
• Start date: October 2014
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: University of Bath
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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 amongst adults.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Motor Activity
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Instant + Multidimensional Physical Activity Feedback

Locations

Country	Name	City	State
United Kingdom	University of Bath: Department for Health	Bath

Sponsors (1)

Lead Sponsor	Collaborator
University of Bath

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, 6 weeks and 12 Weeks	No
Secondary	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).	baseline, 6 weeks and 12 Weeks	No
Secondary	Need satisfaction	Need satisfaction during physical activity will be measured by psychological need satisfaction in exercise (PNSE, Wilson et al., 2006).	baseline, 6 weeks and 12 Weeks	No
Secondary	Habitual physical activity	Habitual physical activity will be measured using the self-reported habit index (SRHI, Verplanken and Orbell, 2003).	baseline, 6 weeks and 12 Weeks	No
Secondary	Vitality	Vitality and quality of life will be assessed using the Subjective vitality index and Quality of life (SF-36, EQ-51) scales.	baseline, 6 weeks and 12 Weeks	No
Secondary	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.	baseline, 6 weeks and 12 Weeks	No