Physical ActivityNCT02880449
Promoting Physical Activity Among Older Women Living in Socio-economically Disadvantaged Areas
A study testing Intervention in people with Physical Activity and Health Behaviour, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
The aim of the project is pilot an intervention to promote physical activity (PA) among older women. Participants will be women aged ≥50 years attending an identified community centre situated in a socioeconomically deprived area of Belfast. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Health Behaviour
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2016to Apr 2017
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females
- Aged over 50 years
- Member of women's community centres in an area of socioeconomic deprivation
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Public Health, Queen's University Belfast
Belfast, BT12 6BJ
About this study
Official title: Promoting Physical Activity Among Older Women Living in Socio-economically Disadvantaged Areas Using a Social Practice Theory Based Intervention: A Pilot Trial
The aim of the project is pilot an intervention to promote physical activity (PA) among older women.
Participants will be women aged ≥50 years attending an identified community centre situated in a socioeconomically deprived area of Belfast. The intervention consists of education, social support and information on local opportunities for physical activity (PA), based on Social Practice Theory. A stepped wedge design shall be used. The intervention was developed using findings from a literature review, systematic review and interviews with stakeholders. Outcome measures are accelerometer data, self-reported PA, a mental health questionnaire and qualitative interviews.
Read the detailed description
Participants will be recruited from previously established older women's community groups. The intervention will utilize existing weekly community group sessions. A stepped wedge design, with a delayed intervention, shall be used to allow a randomised controlled trial to be conducted and to control for seasonal weather effects on PA levels. Two community groups from each centre shall be identified. One group from each centre shall receive the intervention from week one for 6 weeks; the second group shall receive the control condition from week one for 6 weeks and then receive the intervention at week 7 for 6 weeks. The intervention will consist of three educational sessions, encouragement to enlist the support of a partner or 'buddy' (e.g. a spouse, partner or friend), an information pack (containing information on the local area, walking routes, points of interest) and the option of weekly telephone contact. At each weekly meeting, participants will be given the opportunity to discuss their progress and share feedback with the rest of the group to gain peer social support. The intervention was developed using findings from a literature review, systematic review and interviews with stakeholders. The intervention is underpinned by constructs from the Social Practice Theory, a model that facilities behaviour change through the three elements of: materials (information on the local area, telephone calls, interactive group sessions), meanings (benefits of increasing PA, improving physical health and mental well-being) and competencies (encouragement to seek social support, knowledge of how to increase PA, knowledge of the local area).
- Conditions
- Physical Activity, Health Behaviour
- Being tested
- Intervention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
A PA promoting intervention which provides education, social support and information about local opportunities for PA to pre-existing groups of older women living in socio-economically disadvantaged areas
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention will be conducted in pre-existing older women's groups based in community centres. The intervention will consist of three educational sessions, encouragement to enlist the support of a partner or 'buddy' (e.g. a spouse, partner or friend), an information pack (containing information on the local area, walking routes, points of interest) and the option of weekly telephone contact. Participants will be given the opportunity to discuss their progress and share feedback with the rest of the group at weekly meetings. Receives: Behavioral: Intervention |
| Control | No intervention | Due to the stepped wedge design of the study, one group in each centre will not receive the intervention procedure detailed above until week seven. The control groups shall be given information about the study at baseline and informed that they will receive the intervention 6 weeks later. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of steps per day
Changes from baseline number of steps per day measured objectively using an Actigraph accelerometer over a period of seven days.
Measured: Baseline, 12 weeks and 6 months
Secondary outcomes (2)
Mental health
To measure changes in mental health, using the HADS questionnaire, completed by participants
Measured: Baseline, 12 weeks and 6 months
Moderate to vigorous physical activity (MVPA)
Changes from baseline in mean daily minutes of moderate physical activity (MVPA) measured objectively using an Actigraph accelerometer over a period of seven days.
Measured: Baseline, 12 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mark Tully, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880449
- Sponsor's protocol ID
- 16.38
- Status last verified
- Aug 2017
- First submitted
- 23 Aug 2016
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lawlor ER, Cupples ME, Donnelly M, Tully MA. Promoting physical activity among community groups of older women in socio-economically disadvantaged areas: randomised feasibility study. Trials. 2019 Apr 25;20(1):234. doi: 10.1186/s13063-019-3312-9.
PubMed 31023329
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Physical Activity Among Older Women Living in Socio-economically Disadvantaged Areas Using a Social Practice Theory Based Intervention: A Pilot Trial
- ClinicalTrials.gov ID
- NCT02880449
- Acronym / sponsor ID
- 16.38
- Conditions
- Physical Activity, Health Behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 26 Aug 2016 (estimated)
- 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.
The aim of the project is pilot an intervention to promote physical activity (PA) among older women.
Participants will be women aged ≥50 years attending an identified community centre situated in a socioeconomically deprived area of Belfast. The intervention consists of education, social support and information on local opportunities for physical activity (PA), based on Social Practice Theory. A stepped wedge design shall be used. The intervention was developed using findings from a literature review, systematic review and interviews with stakeholders. Outcome measures are accelerometer data, self-reported PA, a mental health questionnaire and qualitative interviews.
Detailed description
Participants will be recruited from previously established older women's community groups. The intervention will utilize existing weekly community group sessions. A stepped wedge design, with a delayed intervention, shall be used to allow a randomised controlled trial to be conducted and to control for seasonal weather effects on PA levels. Two community groups from each centre shall be identified. One group from each centre shall receive the intervention from week one for 6 weeks; the second group shall receive the control condition from week one for 6 weeks and then receive the intervention at week 7 for 6 weeks. The intervention will consist of three educational sessions, encouragement to enlist the support of a partner or 'buddy' (e.g. a spouse, partner or friend), an information pack (containing information on the local area, walking routes, points of interest) and the option of weekly telephone contact. At each weekly meeting, participants will be given the opportunity to discuss their progress and share feedback with the rest of the group to gain peer social support. The intervention was developed using findings from a literature review, systematic review and interviews with stakeholders. The intervention is underpinned by constructs from the Social Practice Theory, a model that facilities behaviour change through the three elements of: materials (information on the local area, telephone calls, interactive group sessions), meanings (benefits of increasing PA, improving physical health and mental well-being) and competencies (encouragement to seek social support, knowledge of how to increase PA, knowledge of the local area).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionThe intervention will be conducted in pre-existing older women's groups based in community centres. The intervention will consist of three educational sessions, encouragement to enlist the support of a partner or 'buddy' (e.g. a spouse, partner or friend), an information pack (containing information on the local area, walking routes, points of interest) and the option of weekly telephone contact. Participants will be given the opportunity to discuss their progress and share feedback with the rest of the group at weekly meetings. |
| Control | No intervention | –Due to the stepped wedge design of the study, one group in each centre will not receive the intervention procedure detailed above until week seven. The control groups shall be given information about the study at baseline and informed that they will receive the intervention 6 weeks later. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Females
- Aged over 50 years
- Member of women's community centres in an area of socioeconomic deprivation
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| InterventionA PA promoting intervention which provides education, social support and information about local opportunities for PA to pre-existing groups of older women living in socio-economically disadvantaged areas | Behavioural | Intervention |
Primary outcome
Total number of steps per day
Time frame: Baseline, 12 weeks and 6 months
Changes from baseline number of steps per day measured objectively using an Actigraph accelerometer over a period of seven days.
2 secondary outcomes
Mental health
Time frame: Baseline, 12 weeks and 6 months
Moderate to vigorous physical activity (MVPA)
Time frame: Baseline, 12 weeks and 6 months
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 17 Aug 2017.
- Derived from this study: PubMed 31023329Lawlor ER, Cupples ME, Donnelly M, Tully MA. Promoting physical activity among community groups of older women in socio-economically disadvantaged areas: randomised feasibility study. Trials. 2019 Apr 25;20(1):234. doi: 10.1186/s13063-019-3312-9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Physical Activity and Health Behaviour, run by Queen's University, Belfast at 1 site 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 3 inclusion and 1 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 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Total number of steps per day (time frame: Baseline, 12 weeks and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02880449, which also lists 1 linked publication.
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 17 Aug 2017.