Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001211651
Ethics application status
Approved
Date submitted
4/09/2023
Date registered
23/11/2023
Date last updated
22/04/2024
Date data sharing statement initially provided
23/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating Mental and Physical Health Approaches for Supporting Men with Depression and Overweight or Obesity: A Feasibility Trial
Scientific title
Feasibility and Preliminary Efficacy of an Online Lifestyle Intervention vs an Online Mental Health Intervention for Men with Depression and Overweight or Obesity: A Pilot Study
Secondary ID [1] 310416 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 331177 0
Overweight 331178 0
Obesity 331754 0
Condition category
Condition code
Mental Health 327952 327952 0 0
Depression
Diet and Nutrition 328503 328503 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1:
SHED-IT Lifestyle Intervention
Intervention description and dose:
Participants in the SHED-IT program receive access to an online program delivered via the Articulate Reach learning management system, which can be accessed via internet browser or an app. Participants will receive the following:
1. A series of online and interactive modules, using the articulate rise program, targeting lifestyle improvements (weight loss, exercise, sleep). The modules include short videos, written material, and links to extra sources of information.
2. Fillable activity sheets that correspond with each online module (e.g., physical activity goal setting)
3. Downloadable resources to monitor progress (e.g., weight chart)
4. Access to the MyFitnessPal app to monitor food and exercise behaviour
5. Weekly text message reminders to complete the program

Program dose:
1. Complete 12 online modules (15 mins each): 3hrs
2. Complete program activities: 2hrs
3. Complete mood & weight check-ins: 30 minutes
Total time: 5.5hrs

SHED=IT is a lifestyle behaviour change intervention, focusing on weight loss and physical activity, by supporting participants to make a series of small changes to eating, exercise, and other lifestyle behaviours.
The program is self-paced over 12 weeks. There are 12 online modules available, so participants may choose to complete 1 module and the corresponding activity per week, or choose to complete the program at their own pace. Use of the resources to monitor progress (weight chart, MyFitnessPal) are encouraged, but not mandatory or monitored. Typically, the weight chart would be used weekly to record weight, and the MyFitnessPal app used daily to monitor diet. The program activities include practical exercises or worksheets that correspond to the information presented in the online modules and ask participants to reflect on current lifestyle factors that can be changed. For example, participants are asked to calculate their daily kj intake and output, set goals for lifestyle behaviour changes and identify ways of increasing incidental physical activity.

Mode: Online, self-directed.

Procedures: After completing an online eligibility survey, participants will attend baseline assessment at the University of Newcastle. After completing their assessments, men who are randomly allocated to this arm will be provided with access to the SHED-IT Articulate Reach platform. Participants will then have access to the program for 3 months.

Materials: Access to Articulate Reach and MyFitnessPal

Location: The program will be accessed by participants from their personal devices in their own time.

Treatment adherence and fidelity: Engagement data will be collected via the Articulate Reach platform in which the program is delivered, and via a survey at the 3 month point regarding acceptability.
Intervention code [1] 326811 0
Lifestyle
Intervention code [2] 327192 0
Behaviour
Comparator / control treatment
Arm 2:
RECHARGE Mental Health Intervention
Intervention description and dose:
Participants in the RECHARGE program receive access to an online program delivered via the Articulate Reach learning management system, which can be accessed via internet browser or an app. Participants will receive the following:
1. A series of online and interactive modules, using the articulate rise program, based on Cognitive Behavioural Therapy targeting Depression. The modules include short videos, written material, and links to extra sources of information.
2. Fillable activity sheets that correspond with each online module (e.g., thought challenging, behavioural activation).
3. Access to symptoms and progress monitoring via the Articulate Reach learning management platform
4. Weekly text message reminders to complete the program

Program dose:
1. Complete 12 online modules (15 mins each): 3hrs
2. Complete program activities: 2hr
3. Complete mood & weight check-ins: 30 minutes
Total time: 5.5hrs

RECHARGE is a Cognitive Behavioural Therapy based intervention designed to target depression. It will include behavioural activation, mindfulness and relaxation, thought and mood monitoring, negative thinking styles and thought challenging. It will also include targeted material on the impact of adherence to masculine norms on mental health.
The program is self-paced over 12 weeks. There are 12 online modules available, so participants may choose to complete 1 module and the corresponding activity per week, or, may choose to complete the program at their own pace. Progress monitoring is encouraged, but not mandatory. Participants will have the option to personally monitor progress using the Patient Healthcare Questionnaire (PHQ-9) weekly via the Articulate Reach platform. Additionally, participants will be sent a link, via SMS, to complete the Patient Healthcare Questionnaire (PHQ-9) 3 times throughout the program which research staff will use to monitor progress and suicidal ideation. The program activities include practical exercises or worksheets that correspond to the information presented in the online modules and ask participants to reflect on thoughts, emotions, and behaviors relevant to their mental health. For example, participants are asked to engage in mindfulness activities that increase awareness of thoughts and emotions, identify activities that meaningful to engage in, learn and practice stress reduction techniques, and learn to challenge automatic thoughts.

Mode: Online, self-directed.

Procedures: After completing an online eligibility survey, participants will attend baseline assessment at the University of Newcastle. After completing their assessments, men who are randomly allocated to this arm will be provided with access to the RECHARGE Articulate reach platform. Participants will then have access to the program for 3 months.

Materials: Access to Articulate reach platform

Location: The program will be accessed by participants from their personal devices in their own time.

Treatment adherence and fidelity: Engagement data will be collected via the Articulate reach platform in which the program is delivered, and via a survey at the 3 month point regarding acceptability.
Control group
Active

Outcomes
Primary outcome [1] 335968 0
Outcome: Recruitment capability
Measure: study database
Metric: number of eligible participants randomised
Indicator of feasibility: 40 participants recruited for trial
Timepoint [1] 335968 0
At the conclusion of study
Primary outcome [2] 335969 0
Outcome: participant satisfaction
Measure: Participants overall satisfaction with therapy using a single item likert scale developed for this study (1 = Poor, 2 = Fair, 3 = Average, 4 = Good, 5 = Excellent).
Metric: mean score
Indicator of feasibility: Mean score at least 4 / 5. Each study arm will be evaluated independently.
Timepoint [2] 335969 0
primary time-point (3 months post-baseline)
Primary outcome [3] 335970 0
Outcome: program usage (number of modules completed) Measure: average proportion of modules completed by participants. Data will be collected via the Articulate Reach platform analytics. Indicator of feasibility: at least 50% of modules completed on average (each study arm will be evaluated independently).
Timepoint [3] 335970 0
primary time-point (3 months post-baseline)
Secondary outcome [1] 426017 0
Outcome: change in weight
Measure: digital scales (kg; total)
Timepoint [1] 426017 0
Baseline, 3 months post-baseline
Secondary outcome [2] 426018 0
Outcome: change in waist circumference
Measure: non-extensible steel tape (cm; total)
Timepoint [2] 426018 0
Baseline, 3 months post-baseline
Secondary outcome [3] 426019 0
Outcome: change in risky alcohol intake
Measure: Alcohol Use Disorders Identification Test (AUDIT-C; total score)
Timepoint [3] 426019 0
Baseline, 3 months post-baseline
Secondary outcome [4] 426020 0
Outcome: change in Sleep
Measure: Pittsburgh Sleep Quality Index (total score)
Timepoint [4] 426020 0
Baseline, 3 months post-baseline
Secondary outcome [5] 426021 0
Outcome: change in Mental wellbeing
Measure: Warwick Edinburgh Mental Well-being Scale (total sc0re)
Timepoint [5] 426021 0
Baseline, 3 months post-baseline
Secondary outcome [6] 426022 0
Outcome: change in physical self-worth
Measure: Physical Self Perception Profile - global physical self-worth items only (mean score)
Timepoint [6] 426022 0
Baseline, 3 months post-baseline
Secondary outcome [7] 426023 0
Outcome: change in Male depressive symptoms
Measure: Male Depression Risk Scale (MDRS-22; total score)
Timepoint [7] 426023 0
Baseline, 3 months post-baseline
Secondary outcome [8] 426024 0
Outcome: change in Anxiety symptoms
Measure: General Anxiety Disorder-7 (GAD-7; total score)
Timepoint [8] 426024 0
Baseline, 3 months post-baseline
Secondary outcome [9] 426025 0
Outcome: change in Conformity to masculine norms
Measure: Conformity to Masculine Norms Inventory (CMNI-22; total score)
Timepoint [9] 426025 0
Baseline, 3 months post-baseline
Secondary outcome [10] 426029 0
Outcome: change in behavioural activation
Measure: Behavioural Activation for Depression Scale – Short Form (total score)
Timepoint [10] 426029 0
Baseline, 3 months post-baseline
Secondary outcome [11] 426033 0
Outcome: change in cognitive flexibility
Measure: Cognitive Flexibility Inventory – alternatives subscale (total score)
Timepoint [11] 426033 0
Baseline, 3 months post-baseline
Secondary outcome [12] 426036 0
Outcome: change in help-seeking attitudes
Measure: Attitudes Towards Professional Psychological Help (total score)
Timepoint [12] 426036 0
Baseline, 3 months post-baseline
Secondary outcome [13] 426042 0
Outcome: change in stigma
Measure: Depression Stigma Scale – personal items (total score)
Timepoint [13] 426042 0
Baseline, 3 months post-baseline
Secondary outcome [14] 426044 0
Outcome: change in % time spent in moderate to vigorous physical activity
Measure: Accelerometers (GT9X Link)
Timepoint [14] 426044 0
Baseline, 3 months post-baseline
Secondary outcome [15] 426045 0
Outcome: change in % time spent in light physical activity
Measure: Accelerometers (GT9X Link)
Timepoint [15] 426045 0
Baseline, 3 months post-baseline
Secondary outcome [16] 426046 0
Body fat percentage will be calculated using a standard formula. The InBody720 bioimpedance machine is no longer being used.
Timepoint [16] 426046 0
Baseline, 3 months post-baseline
Secondary outcome [17] 426047 0
Outcome: change in Body Mass Index
Measure: standard formula (kg/m2). Height measured using a stadiometer, weight measured using digital scales.

Timepoint [17] 426047 0
Baseline, 3 months post-baseline
Secondary outcome [18] 426049 0
Outcome: participant retention
Measure: study database
Metric: number of randomised participants who complete 3-month (primary timepoint) assessment.
Indicator of feasibility: at least 80% of participants retained.
Timepoint [18] 426049 0
Baseline, 3 months post-baseline
Secondary outcome [19] 426305 0
Outcome: change in Depressive symptoms
Measure: Patient Healthcare Questionnaire (PHQ-9; total score)
Timepoint [19] 426305 0
Baseline, 3 months post-baseline
Secondary outcome [20] 426306 0
Outcome: change in average kJ/day
Measure: Australian Eating Survey (AES)
Timepoint [20] 426306 0
Baseline, 3 months post-baseline
Secondary outcome [21] 426307 0
Outcome: change in % Energy from Non-core Food
Measure: Australian Eating Survey (AES)
Timepoint [21] 426307 0
Baseline, 3 months post-baseline
Secondary outcome [22] 426308 0
Outcome: change in % time spent sedentary
Measure: Accelerometers (GT9X Link)
Timepoint [22] 426308 0
Baseline, 3 months post-baseline

Eligibility
Key inclusion criteria
- Are 18 – 70-years-old
- Identifies as a man;
- Persistent low mood for at least two weeks (score of greater than or equal to 10 on the Patient Health Questionnaire – 9 item (PHQ-9))
- Are overweight (determined as a Body Mass Index (BMI) from 25 – 42 kg/m2);
- Have experienced a persistent low mood for at least two weeks;
- Own a computer, tablet or smartphone with internet access;
- Have a current email address and mobile phone number.
Minimum age
18 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Require intensive treatment or hospitalisation, as determined by the study psychologist (e.g., acute suicide risk);
- Have started psychological counselling or therapy in the past 4 weeks;
- Have started a new medication (or changed your dose in the past 4 weeks);
- Have had weight loss surgery in the past 12 months (or plan to during the study);
- Are unable to speak, read or understand English;
- Are participating (or plan to participate) in an alternative weight loss program;
- Are not willing to be randomly allocated into either study group;
- Have intentionally lost 5% or more of your body weight in the past 6 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Information for the two study groups will be pre-packed into identical white, opaque envelopes. These envelopes will be consecutively numbered and ordered according to the randomisation schedule. The packing and sequencing of these envelopes will be completed by a research assistant who is not involved in the enrolment, assessment or allocation of participants.
After each participant has completed the baseline measures, an independent research assistant will complete the randomisation process, where they will open the next available envelope, inform the participant of their group assignment, and provide them access to the relevant Articulate reach program site depending on their allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised at an individual level. The allocation sequence will be generated by a member of the research team who will not be involved in enrolment, assessment, or allocation of participants using a computer-based random number-producing algorithm. Randomisation codes will be stored in a restricted computer folder, which will not be accessible by those assessing participants, those involved in allocating participants to groups or those participating in data entry for the study. Complete separation will be achieved between those who generate the randomisation sequence and pack the envelopes to the research assistant who will open the envelopes and conduct the group assignment process.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: A sample size calculation is not required for pilots, but we will recruit 40 participants to provide stable estimates of retention, satisfaction, and preliminary efficacy. This sample aligns with Whitehead et al's (2016) recommendation for pilot trials of future RCTs that will aim to detect a medium effect size between groups (90% power, two-sided test, p<0.05).
Analyses: Descriptive analyses and chi-squared tests will assess feasibility outcomes. Intention-to-treat linear mixed models will identify the preliminary impact on key efficacy outcomes. As the trial is not specifically powered to detect changes in efficacy-related outcomes, the interpretation of results will focus on the overall group-by-time effect size (cohen's d) rather than indicators of statistical significance.

Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016;25:1057-73. doi:10.1177/0962280215588241 pmid:26092476.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/01/2024
Actual
22/02/2024
Date of last participant enrolment
Anticipated
15/05/2024
Actual
Date of last data collection
Anticipated
15/07/2024
Actual
Sample size
Target
40
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 314629 0
Charities/Societies/Foundations
Name [1] 314629 0
AMP Foundation
Country [1] 314629 0
Australia
Primary sponsor type
Individual
Name
Dr Myles Young
Address
W257 Behavioural SciencesUniversity of NewcastleUniversity DriveCallaghan, 2308NSW AUSTRALIA
Country
Australia
Secondary sponsor category [1] 316705 0
None
Name [1] 316705 0
Address [1] 316705 0
Country [1] 316705 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313647 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 313647 0
Ethics committee country [1] 313647 0
Australia
Date submitted for ethics approval [1] 313647 0
Approval date [1] 313647 0
11/10/2022
Ethics approval number [1] 313647 0
H-2022-0270

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128866 0
Dr Myles Young
Address 128866 0
W257 Behavioural Sciences University of Newcastle University Drive Callaghan, NSW 2308
Country 128866 0
Australia
Phone 128866 0
+61 249216096
Fax 128866 0
Email 128866 0
[email protected]
Contact person for public queries
Name 128867 0
Myles Young
Address 128867 0
W257 Behavioural Sciences University of Newcastle University Drive Callaghan, NSW 2308
Country 128867 0
Australia
Phone 128867 0
+61 249216096
Fax 128867 0
Email 128867 0
[email protected]
Contact person for scientific queries
Name 128868 0
Myles Young
Address 128868 0
W257 Behavioural Sciences University of Newcastle University Drive Callaghan, NSW 2308
Country 128868 0
Australia
Phone 128868 0
+61 249216096
Fax 128868 0
Email 128868 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


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
No additional documents have been identified.