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

Physical Activity Clinical Trial

Official title:

Promoting Physical Activity Among Older Women Living in Socio-economically Disadvantaged Areas Using a Social Practice Theory Based Intervention: A Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02880449
• Other study ID #: 16.38
• Status: Completed
• Phase: N/A
• First received: August 23, 2016
• Last updated: August 14, 2017
• Start date: September 2016
• Est. completion date: April 2017

Study information

• Verified date: August 2017
• Source: Queen's University, Belfast
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Females

• Aged over 50 years

• Member of women's community centres in an area of socioeconomic deprivation

Exclusion Criteria:

Related Conditions & MeSH terms

• Health Behaviour
• Physical Activity

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Centre for Public Health, Queen's University Belfast	Belfast

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University, Belfast

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 12 weeks and 6 months
Secondary	Mental health	To measure changes in mental health, using the HADS questionnaire, completed by participants	Baseline, 12 weeks and 6 months
Secondary	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.	Baseline, 12 weeks and 6 months