DepressionNCT03537053
An Approach to "Move a Little & Often" With Health Conditions
A study testing A plan to Move a Little and Often in people with Depression and Multiple Chronic Conditions, run by University of Manchester at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Multiple Chronic Conditions
- What is being tested?
- A plan to Move a Little and Often
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 21 Sep 2018to 20 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
The University of Manchester
Manchester, M13 9PL
Salford Royal NHS Foundation Trust
Manchester
About this study
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.
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
Read the 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.
- Conditions
- Depression, Multiple Chronic Conditions
- Being tested
- A plan to Move a Little and Often
- Keywords
- Sedentary Lifestyle
- Medical subject headings
- Depression, Multiple Chronic Conditions, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A plan to Move a Little and OftenBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| A plan to Move a Little and Often | Experimental | 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. Receives: Behavioral: A plan to Move a Little and Often |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start21 Sep 2018
- Primary completion20 Jul 2019
- Study completion20 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a single group feasibility study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Principal investigator, Isabel Adeyemi, University of Manchester
- Investigators
- Isabel Adeyemi, MPhil, Principal investigator, The University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537053
- Sponsor's protocol ID
- IRAS ID: 244602
- Status last verified
- Apr 2020
- First submitted
- 1 May 2018
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data on demographics (age, gender) and standardised questionnaire measures will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03537053
- Acronym / sponsor ID
- IRAS ID: 244602
- Conditions
- Depression, Multiple Chronic Conditions
- Keywords
- Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 20 Jul 2019 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a single group feasibility study
| Arm | Type | Receives |
|---|---|---|
| A plan to Move a Little and Often | Experimental | Behavioral: A plan to Move a Little and OftenThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A plan to Move a Little and OftenThe 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). | Behavioural | A plan to Move a Little and Often |
Primary outcome
The short form International Physical Activity Questionnaire (IPAQ ; Booth 2000).
Time frame: 1 month follow-up
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Individual participant dataSharing planned: Yes. Anonymised data on demographics (age, gender) and standardised questionnaire measures will be shared.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabel Adeyemi, MPhil principal investigator
The University of Manchester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A plan to Move a Little and Often in people with Depression and Multiple Chronic Conditions, run by University of Manchester at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The short form International Physical Activity Questionnaire (IPAQ ; Booth 2000). (time frame: 1 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.