An Approach to "Move a Little & Often" With Health Conditions

Exploring the Acceptability of "Move a Little and Often"- a Behaviour Change Intervention to Reduce Sedentary Behaviours in People With Long Term Conditions and Symptoms of Depression.

People with long term conditions such as diabetes and arthritis, and who also have depression spend a lot of time sedentary during the day. This is because they face many barriers to being active, such as pain and fatigue. Being sedentary is problematic because it is associated with poorer health in the long term.

Common sedentary behaviours are watching television and using the computer; these behaviours are labelled as screen-based sedentary behaviours. An intervention to reduce these behaviours could improve mental and physical wellbeing. The aim of the study is to explore the acceptability of an intervention to "Move a Little and Often" in people with depression symptoms and long term conditions. The investigators will explore the intervention's acceptability using interviews and will examine if the intervention is associated with a reduction in time spent sedentary. Results will help refine the intervention further.

The feasibility study is part of a PhD project funded by the National Institute of Health Research (NIHR) Collaborations for Leadership in Applied Health Research and Care (CLAHRC) Greater Manchester

Study Overview

• Status: Completed
• Conditions: Depression; Multiple Chronic Conditions
• Intervention / Treatment: Behavioral: A plan to Move a Little and Often

Detailed Description

There is a growing focus in research on the need to reduce sedentary behaviours. Studies have shown that independently of moderate to vigorous physical activity, the amount of time spent sedentary predicts poorer health outcomes. This means that in addition to exercising, it is important to reduce prolonged periods of sedentary behaviours to improve health. For people with depression and long term conditions, milder forms of physical activity may be more appropriate due to higher levels of pain and fatigue resulting from exercise. Reducing sedentary behaviours by substituting them with mild physical activities such as walking is a potential avenue to improve health outcomes in this population group.

To date, no intervention has been developed to reduce prolonged periods of sedentariness in people with depression and long term health conditions within the UK. This feasibility study aims to refine a behaviour change intervention to reduce sedentary time in this population group. The intervention has been developed through reviewing the literature on interventions to increase physical activity (a systematic review), an interview study to explore sedentary and physical activity behaviours within this population group, and through patient and public involvement.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9PL
    • The University of Manchester
  • Manchester, United Kingdom
    • Salford Royal NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• be aged ≥18 years,
• self-report a clinical diagnosis of a long term physical health condition;
• score 8 or more on the depression subscale of the Hospital hospital anxiety and depression scales (Zigmond & Snaith, 1983) suggesting the presence of depression;
• speak English fluently;
• live within Greater Manchester

Exclusion Criteria:

• are not registered with a GP practice,
• in receipt of palliative care,
• report a diagnosis of severe mental health problems such as schizophrenia or bipolar disorder,
• have had a recent bereavement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: A plan to Move a Little and Often; The intervention will consist of 3 components: a short video will raise awareness about the impact of sedentary behaviours, a booklet, and an online forum on Facebook to encourage participants to support each other. At the end of the baseline data collection, participants will be asked to watch the video. They will then be given the booklet and invited to join the Facebook group. A minimum of 5 participants must be recruited prior to running the Facebook group.

Behavioral: A plan to Move a Little and Often; The intervention content is reported using the behaviour change technique (BCT) Taxonomy v1 (Michie, et al. 2013). The video will contain the BCT: information about health consequences. The booklet will consist of BCTs: self-monitoring of behaviour, goal setting behaviour, action planning, commitment, social support (practical), self-talk, and mental rehearsal of successful performance. Lastly, usage of the Facebook group will include BCTs: commitment, and social support unspecified, practical and emotional. Mental rehearsal, goal setting behaviour and action planning will be delivered through mental simulation exercises (Taylor, et al. 1998). BCTs self-monitoring of behaviour, goal setting behaviour, and commitment will be delivered using implementation intentions (Gollwitzer 1993).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The short form International Physical Activity Questionnaire (IPAQ ; Booth 2000).	The IPAQ will be used to measure frequency and duration of sedentariness, and any increase in physical activity. The IPAQ asks about walking, moderate intensity activities and vigorous-intensity activities. In order to compute the total score, it requires summation of the durations (minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities.	1 month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedentary Behaviour Questionnaire (Gardiner, et al. 2011)	The Sedentary Behaviour Questionnaire is a seven-item questionnaire that asks participants to report on activities they did during the last week while they were sitting or lying down, and to report the total time spent in each activity. The seven individual sedentary items are TV or video/DVD watching, computer use, reading, socializing with friends or family, time traveling in a motor vehicle or on public transport, doing hobbies, and any other activities they did while they were sitting or lying down. The measure has previously been used in a study of sedentariness in older adults (Gardiner, et al. 2011).	1 month follow-up
The International Sedentary Assessment Tool (ISAT; Prince, et al. 2017)	The ISAT contains 5 items relating to total time spent sedentary and time spent doing specific activities: television use, computer use, using transport, and reading. Participants will be asked how much time they spend on each activity over the course of a typical week. Psychometric properties have yet to be reported for this questionnaire measure.	1 month follow-up
The Hospital Anxiety and Depression Scale (HADS; Zigmond and Snaith 1983)	The HADS will measure depression and anxiety. The HADS is a 14-item self-report screening scale for anxiety and depression symptoms. It contains two 7 item scales: one for anxiety and one for depression; both of which have a score ranging from 0-21. The HADS is commonly used in research studies and has good validity (Bjelland et al. 2002, et al. 2005).	1 month follow-up
The Numeric Rating Scale (NRS; Herr and Mobily 1993).	Pain will be measured using the 0-10 Numeric Rating Scale (NRS) (Herr and Mobily 1993). Participants will be asked to rate their pain over the previous week. This questionnaire has been found to correlate significantly with other pain measures (Herr, et al. 2004). Scores can range from 0 to 10, with higher scores indicating more pain.	1 month follow-up
The Pittsburgh Sleep Quality Index (Buysse, et al. 1989)	Sleep quality and disturbances will be measured using the Pittsburgh Sleep Quality Index (Buysse, et al. 1989). The questionnaire can be used to generate seven component scores for subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each of the seven component scores is weighted equally on a scale of 0 (no difficulty) to 3 (severe difficulty). The seven component scores are then summed to yield a global PSQI score, ranging from 0 to 21, with a higher score indicating poorer sleep quality.	1 month follow-up
The Measure of National Wellbeing (Carter 2017)	Quality of life will be measured using items from the Measure of National Wellbeing used by the Office for National Statistics. Participants will be asked: overall, how satisfied they are with life nowadays; overall, to what extent they feel the things they do in life are worthwhile; overall, how happy they felt yesterday; overall, how anxious they felt yesterday?. Each question is answered on a scale of 0 to 10. People are asked to respond on a scale of 0 to 10, where 0 is "not at all" and 10 is "completely". Mean ratings for all 4 personal well-being questions will be calculated.	1 month follow-up
Short Form Health Survey (SF-12; Ware, et al. 1996)	The SF 12 is a 12 item measure with two scales: mental and physical functioning and overall health-related-quality of life. The SF-12 is weighted and summed to provide Physical and Mental Health Composite Scores (PCS & MCS). These two composite scores are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The questionnaire was adapted from the SF-36 Health Survey and its results can be compared with the SF36 (Jenkinson, et al. 1997)	1 month follow-up
The ENRICHD Social Support Instrument (Mitchell, et al. 2003)	Social support will be measured using the ENRICHD Social Support Instrument (Mitchell, et al. 2003). The ENRICHD Social Support Instrument (ESSI) is a brief seven-item measure of perceived social support. The scale contains six social support items that have been shown to be individually predictive of poor outcome in patients with cardiac disease, and one item that assesses partner status.	1 month follow-up
The Self-Report Behavioural Automaticity Index SRBAI (Gardner, et al. 2012)	The SRBAI will be used to measure habit strength for avoiding sedentariness. Participants will be asked to rate 4 items on a Likert scale of 0 (strongly disagree) to 5 (strongly agree). The 4 items are: avoiding being sedentary is something:- 1) I do automatically; 2) I do without having to consciously remember,3) I do without thinking, 4) I start doing before I realise I'm doing it.	1 month follow-up

Collaborators and Investigators

• Sponsor: University of Manchester
• Collaborators: NIHR CLAHRC
• Investigators: Principal Investigator: Isabel Adeyemi, MPhil, The University of Manchester

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2018
• Primary Completion (Actual): July 20, 2019
• Study Completion (Actual): July 20, 2019

Study Registration Dates

• First Submitted: May 1, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (Actual): May 25, 2018

Study Record Updates

• Last Update Posted (Actual): April 10, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Sedentary Lifestyle
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Disease Attributes; Chronic Disease; Depression; Disease; Multiple Chronic Conditions
• Other Study ID Numbers: IRAS ID: 244602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised data on demographics (age, gender) and standardised questionnaire measures will be shared.
• IPD Sharing Time Frame: The data will become available upon publication of the study in an academic journal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No