NCT06407557

Brief Summary

There will be a multi-channel approach to recruitment. Currently, ongoing projects within diverse communities lead in Swansea, Bridgend, and Neath Port Talbot will be approached, and this research will recruit alongside these projects. Regional coordinators and sub-coordinators will be contacted for recruitment, to best ensure participating older adults reflect the typical socio-demographics of Wales. This network will help the researchers to reach older adults who previously took part in different projects. Recruitment letter posters/leaflets will be used as an enrolment technique. Furthermore, the researchers will place advertisements across the University using the intranet and work alongside the City and County of Swansea, Neath Port Talbot, and Bridgend Borough Council to recruit using their sport, play, and community networks. The first stage of recruitment involves approaching diverse community organizations to formally request approval to recruit via their contacts. In-stage gatekeepers will be approached by the researcher to seek permission to contact potential participants via their organization. All interested participants will be asked to contact the researcher directly to further discuss the study and indicate their interest. All participants will provide written informed consent to participate in the study before the baseline assessment is conducted. Moreover, each older adult will receive a sleeping log (to record not wearing time), an accelerometer device, and instructions on how to attach and wear the device for 7 consecutive days. The primary researcher will be contacted if older adults have any queries or issues with the device. The participants will be subsequently randomized to an intervention group or comparison group on the basis of 1:1 allocation. All assessments including questionnaires and a 7-day accelerometer assessment will be repeated post-intervention. An Independent t-test will be run to assess the pre-post difference in the effectiveness of the trial in the intervention and comparison groups. The regression model will be applied to assess the impact of covariates with the dependent variables (MVPA, daily step count, self-efficacy, well-being, and sedentary behaviour). Qualitative data analysis of interview data will use reflexive thematic analysis to illustrate common themes regarding the acceptability of the feasibility trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

February 8, 2024

Last Update Submit

May 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasibility assessment

    Retention = Older adults completed post intervention assessment (semi-structured interviews)/ older adults enrolled \* 100

    2 months

Secondary Outcomes (7)

  • Activity

    2 months

  • Self-efficacy

    2 months

  • Sitting Behaviours

    2 months

  • Well-being

    2 months

  • Acceptability

    3 months

  • +2 more secondary outcomes

Study Arms (2)

Accelerometer

ACTIVE COMPARATOR
Behavioral: Accelerometer

No arm accelerometer

ACTIVE COMPARATOR
Behavioral: Accelerometer

Interventions

AccelerometerBEHAVIORAL

Use of prompts to enable activity in older adults.

AccelerometerNo arm accelerometer

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • All participants aged ≥ 65 years old and able to do their daily living activities.
  • Be able to communicate in English.
  • Self-reported daily sitting time of 6 hours/day

You may not qualify if:

  • are not able to cooperate with the research team for the full duration of the project.
  • any exercise contraindications
  • cognitive impairment, or other mental health diagnosis and/or psychological impairment.
  • living in a supported nursing home or in long-term care.
  • participating in daily moderate to vigorous physical activity level (\> 150 minutes/week) These criteria were put in place to ensure a group of sedentary older adults who could safely alter their sitting habits in an unsupervised intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swansea University

Swansea, SA1 8EN, United Kingdom

Location

Related Publications (1)

  • Meghani NAA, Hudson J, Stratton G, Mullins J, Sahoo D. A multi-method feasibility trial of a multi-component behaviour change intervention to reduce sedentary behaviour and increase physical activity among ethnically diverse older adults. BMJ Open. 2024 Nov 7;14(11):e084645. doi: 10.1136/bmjopen-2024-084645.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2024

First Posted

May 9, 2024

Study Start

January 1, 2024

Primary Completion

April 22, 2024

Study Completion

April 22, 2024

Last Updated

May 9, 2024

Record last verified: 2024-05

Locations