NCT02880449

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

August 17, 2017

Status Verified

August 1, 2017

Enrollment Period

7 months

First QC Date

August 23, 2016

Last Update Submit

August 14, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Mental health

    Baseline, 12 weeks and 6 months

  • Moderate to vigorous physical activity (MVPA)

    Baseline, 12 weeks and 6 months

Study Arms (2)

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.

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.

Interventions

InterventionBEHAVIORAL

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

Intervention

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Public Health, Queen's University Belfast

Belfast, BT12 6BJ, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor Activity

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 23, 2016

First Posted

August 26, 2016

Study Start

September 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

August 17, 2017

Record last verified: 2017-08

Locations