- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02880449
Promoting Physical Activity Among Older Women Living in Socio-economically Disadvantaged Areas
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Belfast, United Kingdom, BT12 6BJ
- Centre for Public Health, Queen's University Belfast
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Females
- Aged over 50 years
- Member of women's community centres in an area of socioeconomic deprivation
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
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.
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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
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No Intervention: Control
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total number of steps per day
Time Frame: Baseline, 12 weeks and 6 months
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Changes from baseline number of steps per day measured objectively using an Actigraph accelerometer over a period of seven days.
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Baseline, 12 weeks and 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental health
Time Frame: Baseline, 12 weeks and 6 months
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To measure changes in mental health, using the HADS questionnaire, completed by participants
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Baseline, 12 weeks and 6 months
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Moderate to vigorous physical activity (MVPA)
Time Frame: Baseline, 12 weeks and 6 months
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Changes from baseline in mean daily minutes of moderate physical activity (MVPA) measured objectively using an Actigraph accelerometer over a period of seven days.
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Baseline, 12 weeks and 6 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 16.38
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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