Clinical trial NCT03537053: An Approach to "Move a Little & Often" With Health Conditions
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Multiple Chronic Conditions
Keywords: Sedentary Lifestyle
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: NIHR CLAHRC
First posted: 2018-05-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a single group feasibility study
Primary purpose: OTHER

Brief summary: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: The short form International Physical Activity Questionnaire (IPAQ ; Booth 2000).
timeFrame: 1 month follow-up
Secondary outcomes:
Other outcomes:
measure: Sedentary Behaviour Questionnaire (Gardiner, et al. 2011)
timeFrame: 1 month follow-up
measure: The International Sedentary Assessment Tool (ISAT; Prince, et al. 2017)
timeFrame: 1 month follow-up
measure: The Hospital Anxiety and Depression Scale (HADS; Zigmond and Snaith 1983)
timeFrame: 1 month follow-up
measure: The Numeric Rating Scale (NRS; Herr and Mobily 1993).
timeFrame: 1 month follow-up
measure: The Pittsburgh Sleep Quality Index (Buysse, et al. 1989)
timeFrame: 1 month follow-up
measure: The Measure of National Wellbeing (Carter 2017)
timeFrame: 1 month follow-up
measure: Short Form Health Survey (SF-12; Ware, et al. 1996)
timeFrame: 1 month follow-up
measure: The ENRICHD Social Support Instrument (Mitchell, et al. 2003)
timeFrame: 1 month follow-up
measure: The Self-Report Behavioural Automaticity Index SRBAI (Gardner, et al. 2012)
timeFrame: 1 month follow-up
Locations:
city: Manchester
country: United Kingdom
facility: The University of Manchester
city: Manchester
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
Study officials:
affiliation: The University of Manchester
name: Isabel Adeyemi, MPhil
role: PRINCIPAL_INVESTIGATOR
References: