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Promoting Physical Activity Among Older Women Living in Socio-economically Disadvantaged Areas

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified August 2016 by Dr Mark Tully, Queen's University, Belfast
Sponsor:
Information provided by (Responsible Party):
Dr Mark Tully, Queen's University, Belfast
ClinicalTrials.gov Identifier:
NCT02880449
First received: August 23, 2016
Last updated: August 25, 2016
Last verified: August 2016
  Purpose

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.


Condition Intervention
Physical Activity Health Behaviour Behavioral: Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Promoting Physical Activity Among Older Women Living in Socio-economically Disadvantaged Areas Using a Social Practice Theory Based Intervention: A Pilot Trial

Resource links provided by NLM:


Further study details as provided by Dr Mark Tully, Queen's University, Belfast:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Mental health [ Time Frame: Baseline, 12 weeks and 6 months ]
    To measure changes in mental health, using the HADS questionnaire, completed by participants

  • Moderate to vigorous physical activity (MVPA) [ Time Frame: Baseline, 12 weeks and 6 months ]
    Changes from baseline in mean daily minutes of moderate physical activity (MVPA) measured objectively using an Actigraph accelerometer over a period of seven days.


Estimated Enrollment: 40
Study Start Date: September 2016
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Intervention
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
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.

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).
  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Females
  • Aged over 50 years
  • Member of women's community centres in an area of socioeconomic deprivation

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02880449

Contacts
Contact: Emma Lawlor, BSc elawlor01@qub.ac.uk
Contact: Mark A Tully, PhD +44 (0)2890632721 m.tully@qub.ac.uk

Locations
United Kingdom
Centre for Public Health, Queen's University Belfast
Belfast, United Kingdom, BT12 6BJ
Sponsors and Collaborators
Queen's University, Belfast
  More Information

Responsible Party: Dr Mark Tully, Lecturer, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT02880449     History of Changes
Other Study ID Numbers: 16.38
Study First Received: August 23, 2016
Last Updated: August 25, 2016

ClinicalTrials.gov processed this record on July 27, 2017