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

August 14, 2017 updated by: Dr Mark Tully, Queen's University, Belfast

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Belfast, United Kingdom, BT12 6BJ
        • Centre for Public Health, Queen's University Belfast

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 12 weeks and 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mental health
Time Frame: Baseline, 12 weeks and 6 months
To measure changes in mental health, using the HADS questionnaire, completed by participants
Baseline, 12 weeks and 6 months
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.
Baseline, 12 weeks and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Queen's University, Belfast

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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