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Completed

NCT Number: NCT02432924

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

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bath: Department for Health

Bath, BA2 7AY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Instant + Multidimensional Physical Activity Feedback

Behavioral

Other names: Bodymedia

Primary outcomes

  1. 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.

Secondary outcomes

  1. Motivation for Physical activity

    Time frame: baseline, 6 weeks and 12 Weeks

    Motivation for physical activity will be assessed using an adapted version of the behavioural regulations for exercise questionnaire (BREQ-2, Markland and Tobin, 2004).

  2. Need satisfaction

    Time frame: baseline, 6 weeks and 12 Weeks

    Need satisfaction during physical activity will be measured by psychological need satisfaction in exercise (PNSE, Wilson et al., 2006).

  3. Habitual physical activity

    Time frame: baseline, 6 weeks and 12 Weeks

    Habitual physical activity will be measured using the self-reported habit index (SRHI, Verplanken and Orbell, 2003).

  4. Vitality

    Time frame: baseline, 6 weeks and 12 Weeks

    Vitality and quality of life will be assessed using the Subjective vitality index and Quality of life (SF-36, EQ-51) scales.

  5. QIntervention: Change in cardiovascular disease and type 2 diabetes risk

    Time frame: baseline, 6 weeks and 12 Weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Bath

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 4, 2015
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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