Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000939897
Ethics application status
Approved
Date submitted
10/06/2021
Date registered
19/07/2021
Date last updated
11/01/2023
Date data sharing statement initially provided
19/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The development, implementation and evaluation of an online Movement, Interaction and Nutrition for Greater Lifestyles in the Elderly (MINGLE) program for people with age-related macular degeneration
Scientific title
The development, implementation and evaluation of an online Movement, Interaction and Nutrition for Greater Lifestyles in the Elderly (MINGLE) program for people with age-related macular degeneration
Secondary ID [1] 304453 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-related macular degeneration 322274 0
Condition category
Condition code
Eye 319959 319959 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 1 of this study includes once-off, audio-recorded semi-structured interviews with AMD patients recruited from a private eye clinic in Western Sydney, Australia. These interviews are estimated to take an average of 20 minutes and will help to identify the barriers and facilitators to participating in MINGLE and inform any modifications to the program prior to Phase 2 of the study. These interviews will be administered by a member of the research team either face-to-face or via telephone, depending on the participant's preference and the general health recommendations during the global pandemic.
Phase 2 of this study is the online intervention, which will be administered via Zoom. It will commence after the preliminary analysis of Phase 1 data. Participants for Phase 2 will be recruited from the same private eye clinic as described in Phase 1. Participants of Phase 1 will also be given the opportunity to participate in Phase 2 if they are interested. A draft form of the program will involve the following: Participants will be divided into subgroups based on session timings (morning/afternoon). Sessions will run for 60-minutes once/week over ten-weeks. Sessions will be structured as follows: 10 minutes informal socialising; 30 minutes physical activity session; 15 minutes nutrition education. The physical activity session will not require any equipment other than a chair and will be facilitated by the research assistant (with an exercise-related qualification) and a research student who will be enrolled in a medical/allied health degree. Each physical activity session will be the same and proposed to include: 5-minute mindful breathing, 15-minute warm-up and moderate intensity exercises (e.g. stretching and bodyweight strengthening exercises), and 10-minute cool down (e.g. balance exercises and stretching). Participants will be given a short break to use the facilities and drink water before commencing the 15-minute nutrition education session with a focus on evidence-based topics. These topics include evidence-based nutritional supplements - what's out there and what's recommended; key nutrients for eye health e.g., lutein and zeaxanthin; the Australian Dietary Guidelines - core food groups and serving sizes. The format of nutrition education will vary and range from presentations by the research assistant and/or student to interactive activity and/or discussion.
Adherence to the intervention will be assessed by systematically tracking all participant contacts to allow for reporting on: the number sessions attended, completed sessions (‘dose’ of intervention received), and reasons for missed sessions. The session content will be tracked via checklists completed after each session allowing for reporting on the extent to which the intervention content is delivered per protocol and percentage of participants engaging/completing the activities.
Intervention code [1] 320797 0
Lifestyle
Intervention code [2] 320798 0
Behaviour
Intervention code [3] 320799 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327832 0
The primary outcome of this intervention is any change in loneliness. This outcome will be assessed using the De Jong Gierveld Scale.
Timepoint [1] 327832 0
Baseline and immediately post-intervention (week 10)
Secondary outcome [1] 396718 0
The secondary outcome is any change in depression. This outcome will be assessed using the Assessment of Quality of Life (AQoL)-8D's mental health dimension.
Timepoint [1] 396718 0
Baseline and immediately post-intervention (week 10)
Secondary outcome [2] 397631 0
Another secondary outcome of this intervention is any change in falls-self-efficacy. This outcome will be measured using the Falls Self-Efficacy Scale.
Timepoint [2] 397631 0
Baseline and immediately post-intervention (week 10).
Secondary outcome [3] 397632 0
Another secondary outcome is any change in physical activity. This outcome will be assessed using the Active Australia Survey which captures leisure-time physical activity.
Timepoint [3] 397632 0
Baseline and immediately post-intervention (week 10).
Secondary outcome [4] 397633 0
Another secondary outcome is any change in dietary intake. This outcome will be assessed using the researcher-developed Short Dietary Questionnaire for Age-Related Macular Degeneration (SDQ-AMD).
Timepoint [4] 397633 0
Baseline and immediately post-intervention (week 10).
Secondary outcome [5] 404565 0
Another secondary outcome is any change in quality of life. This will be assessed using the AQoL-8D.
Timepoint [5] 404565 0
Baseline and immediately post-intervention (week 10)
Secondary outcome [6] 404566 0
Another secondary outcome is attitudes towards the intervention. This will be assessed using the Attitudes to Falls-Related Intervention Scale and provided data on program acceptability and feasibility.
Timepoint [6] 404566 0
Immediately post-intervention (week 10)
Secondary outcome [7] 404567 0
Post-intervention feedback
Timepoint [7] 404567 0
Post-intervention feedback will be collected via group discussions and a post-intervention feedback form. This data will help to inform program acceptability and feasibility.
Secondary outcome [8] 404568 0
Program adherence
Timepoint [8] 404568 0
Program attendance will be assessed using an attendance checklist. This data will help to inform program acceptability.

Eligibility
Key inclusion criteria
Phase 1 (semi-structured interviews) eligibility: 1) aged >= 50 years with a diagnosis of any form of AMD, 2) fluent English, 3) consent to participate in the study (including audio recording).
Phase 2 (pilot study) eligibility: 1) aged >= 50 years with a diagnosis of any form of AMD, 2) fluent English, 3) access to a smart phone, tablet or laptop with a front-facing camera; 4) technical ability to use Zoom or have someone to help; 4) clearance to safely participate in the physical activity components of the intervention (i.e. Physical Activity Readiness Questionnaire (PARQ+) or written physician clearance for participation; 5) written informed consent to participate.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Phase 2 exclusion criteria: 1) unable to ambulate/walk for exercise; 2) serious illness limiting their ability to exercise or complete the trial; 3) contraindications to exercise (i.e. failure to fulfil the prerequisites of the PARQ+); 4) uncontrolled hypertension (>=160/>90 mmHg); 5) signs or symptoms of alcohol/substance abuse and; 6) unable to commit to attending at least 80% of the sessions.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Phase 1: Recruitment of participants until data saturation achieved. According to a previous qualitative study conducted in people with AMD, approximately 30 participants were required to achieve this. Verbatim transcripts of the focus groups/semi-structured interviews will be analysed iteratively to ensure analytic reflexivity. Transcripts will be coded separately by the research assistant and research student, using the Capability, Opportunity, Motivation and Behaviour (COM-B) model of the behaviour change wheel and discussed with the investigators. The research assistant and student will then establish themes under each subset of the COM-B model relating to barriers and facilitators to participating in an interactive online program. Phase 1 findings will inform the design of the program.
Phase 2: At least 52 participants are required to achieve a pre-post change in quality of life assuming a 0.4 effect size according to Cohen’s d and 80% power (G*Power 3.1 software). Statistical analysis will be carried out using IBM SPSS Statistics V.25. Descriptive statistics will be used to assess the acceptability and feasibility of MINGLE. T-tests will be carried out to assess the pre-post intervention improvement in quality of life, falls efficacy, physical activity, and dietary intakes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/11/2021
Actual
4/11/2021
Date of last participant enrolment
Anticipated
31/03/2023
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
82
Accrual to date
26
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 34338 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 308814 0
Charities/Societies/Foundations
Name [1] 308814 0
The Macular Disease Foundation Australia
Country [1] 308814 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
16 University Avenue, Macquarie University NSW 2109
Country
Australia
Secondary sponsor category [1] 309732 0
None
Name [1] 309732 0
Address [1] 309732 0
Country [1] 309732 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308727 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 308727 0
75 Talavera Road, Level 3, Macquarie University, NSW 2109, Australia
Ethics committee country [1] 308727 0
Australia
Date submitted for ethics approval [1] 308727 0
09/06/2021
Approval date [1] 308727 0
10/08/2021
Ethics approval number [1] 308727 0

Summary
Brief summary
Targeted lifestyle interventions that include education, behaviour change and/or group support components could be effective in improving the lifestyle risk factors, increased falls risk and poorer mental health status associated with age-related macular degeneration (AMD). This study therefore aims to develop, implement and evaluate an online intervention through the Movement, Interaction and Nutrition for Greater Lifestyles in the Elderly (MINGLE) program. This will be achieved over two phases: 1) a small qualitative study (semi-structured interviews) with AMD patients to determine the barriers and facilitators to participating in such a program; and 2) applying the findings from phase 1 to inform the development of the MINGLE program, followed by a pilot study to evaluate its feasibility and acceptability. Participants will be recruited from a private eye clinic in Westmead NSW. Eligible Phase 1 participants will be: 1) aged >= 50 years with a diagnosis of any form of AMD, 2) fluent in English, 3) verbally consent to participate in the study (including audio recording). Audio recordings will be transcribed verbatim by a transcribing service and analysed and coded iteratively to ensure analytic reflexivity. Key themes will be established relating to barriers and facilitators to participating in MINGLE. Eligible Phase 2 participants will be 1) aged >= 50 years with a diagnosis of any form of AMD, 2) fluent in English, 3) able to access a smart device with a front-facing camera; 4) technically capable to use Zoom or have someone to help; 4) cleared to safely participate in the physical activity components of the intervention (i.e. Physical Activity Readiness Questionnaire or written physician clearance for participation). Participants also agree to provided written informed consent to participate and complete the baseline questionnaire. For the intervention, participants will be divided into subgroups based on session timings (morning/afternoon). Sessions will run for 60-minutes once/week over ten-weeks with each session including 10 minutes informal socialising; 30 minutes physical activity session; 15 minutes nutrition education. Descriptive statistics will be used to assess the acceptability and feasibility of MINGLE. T-tests will be carried out to assess the pre-post intervention improvement in quality of life, falls efficacy, physical activity, and dietary intakes. The baseline questionnaire will be re-administered immediately post-intervention. The primary outcomes of the questionnaire are significant improvements in loneliness. The secondary outcomes are significant improvements in quality of life, attitudes towards the intervention, falls self-efficacy, physical activity level and diet. The primary process outcome of this study is the development of a novel holistic online intervention with a focus on socialisation, physical activity, and nutrition education to specifically improve the wellbeing of people with AMD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111682 0
Dr Diana Tang
Address 111682 0
Room 3.514, Australian Hearing Hub, 16 University Avenue, Macquarie University, Macquarie Park NSW 2109
Country 111682 0
Australia
Phone 111682 0
+61 298507431
Fax 111682 0
Email 111682 0
[email protected]
Contact person for public queries
Name 111683 0
Dr Diana Tang
Address 111683 0
Room 3.514, Australian Hearing Hub, 16 University Avenue, Macquarie University, Macquarie Park NSW 2109
Country 111683 0
Australia
Phone 111683 0
+61 298507431
Fax 111683 0
Email 111683 0
[email protected]
Contact person for scientific queries
Name 111684 0
Dr Diana Tang
Address 111684 0
Room 3.514, Australian Hearing Hub, 16 University Avenue, Macquarie University, Macquarie Park NSW 2109
Country 111684 0
Australia
Phone 111684 0
+61 298507431
Fax 111684 0
Email 111684 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At this stage there is no patient permission to share this data outside of the study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDevelopment, implementation and evaluation of the online Movement, Interaction and Nutrition for Greater Lifestyles in the Elderly (MINGLE) program: The protocol for a pilot trial.2022https://dx.doi.org/10.1371/journal.pone.0267581
N.B. These documents automatically identified may not have been verified by the study sponsor.