Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001209189
Ethics application status
Approved
Date submitted
20/08/2019
Date registered
30/08/2019
Date last updated
15/06/2021
Date data sharing statement initially provided
30/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
SHED-IT Recharge: Evaluation of an online weight loss program for men with low mood.
Scientific title
SHED-IT Recharge: Evaluation of an online weight loss program for men with low mood.
Secondary ID [1] 298712 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SHED-IT (Self-Help, Exercise and Diet using Information Technology)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/Obesity 313719 0
Depression 313720 0
Condition category
Condition code
Diet and Nutrition 312128 312128 0 0
Obesity
Mental Health 312129 312129 0 0
Depression
Public Health 312130 312130 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Men in the intervention group will receive the SHED-IT Recharge Program. This 3-month program will be based on the SHED-IT Weight Loss Program for Men, which has been validated in previous RCTs. Given the study is specifically targeting men with overweight/obesity and low mood, the program will be adapted to include additional information and strategies supporting men's mental health, which will be specifically created for this study.

As with the SHED-IT program, SHED-IT: Recharge will be an eHealth, self-directed program. As such, participants will complete the program independently in their own home, without the need to engage with a program facilitator. The program will also be ‘gender-tailored’, targeting both surface structure components (e.g., male images and statistics) and deep-structure components, which align with men’s preferences and values (e.g., frank and realistic communication, humour).

At the point of randomisation, all men in the intervention group will receive:

i) The SHED-IT: Recharge Guide to Physical and Mental Fitness (hardcopy)
ii) The SHED-IT: Recharge Log Book (hardcopy document to complete key program tasks, e.g., weight monitoring), and
iii) Access to the SHED-IT: Recharge Website, which will include a series of weight loss video clips containing non-prescriptive dietary and exercise advice, brief strength training workout videos (5-10 minutes), which will be uploaded weekly, and four ‘mental fitness’ modules to be completed over the 3 months. These modules will target evidence-based cognitive-behavioural techniques for managing depressive symptoms (e.g., cognitive restructuring, mindfulness, behavioural activation) and will be made available in Weeks 4, 7, 10, and 13 of the program. Each module will take approximately 15-20 minutes to complete.
iv) A pedometer to track physical activity habits
v) Weekly motivational text messages

Men will also be encouraged to monitor their weight (weekly) and their food and exercise behaviours (4 days/week) using the freely available MyFitnessPal app or website.

Adherence to the program will be assessed by the participant's completion of key weekly log book tasks (e.g., goal setting, weight monitoring). Participants also self-report their use of MyFitnessPal in the Log Books each week. Group-level engagement with the website will be assessed using Google Analytics.
Intervention code [1] 315043 0
Treatment: Other
Intervention code [2] 315044 0
Lifestyle
Intervention code [3] 315045 0
Behaviour
Comparator / control treatment
The self-assessment control group will not receive the SHED-IT Recharge intervention until after they have completed the 6-month assessment.

For duty of care purposes, control participants will be asked to self-report their depressive symptoms every 6 weeks during the trial. These responses will be monitored and participants experiencing notable symptoms exacerbations will be contacted by the study psychologist to discuss support options. Wait-list participants will not be prevented from seeking external help to support their mental health during the study period if required.
Control group
Active

Outcomes
Primary outcome [1] 320767 0
Weight (kg) measured in light clothing, without shoes on a digital scale.
Timepoint [1] 320767 0
Baseline, 3 months post-baseline (primary endpoint), and 6 months post-baseline.
Primary outcome [2] 320769 0
Depressive Symptoms, measured using the 9-item Patient Health Questionnaire (PHQ-9).
Timepoint [2] 320769 0
Baseline, 3 months post-baseline (primary endpoint), and 6 months post-baseline.
Secondary outcome [1] 372772 0
Waist Circumference, measured level with the umbilicus using a non-extensible steel tape.
Timepoint [1] 372772 0
Baseline, 3 months post-baseline, and 6 months post-baseline.
Secondary outcome [2] 372782 0
Anxiety symptoms, measured using the 7-item Generalised Anxiety Disorder Questionnaire (GAD-7).
Timepoint [2] 372782 0
Baseline, 3 months post-baseline, and 6 months post-baseline.
Secondary outcome [3] 372785 0
Sleep quality, measured with the Global Pittsburgh Sleep Quality Index (PSQI) score.
Timepoint [3] 372785 0
Baseline, 3 months post-baseline, and 6 months post-baseline.
Secondary outcome [4] 372786 0
Risky alcohol intake, measured using the Alcohol Use Disorders Identification Test (AUDIT)
Timepoint [4] 372786 0
Baseline, 3 months post-baseline, and 6 months post-baseline.
Secondary outcome [5] 372787 0
Average meal portion sizes, measured using portion size photographs from the Dietary Questionnaire for Epidemiological Studies v2
Timepoint [5] 372787 0
Baseline, 3 months post-baseline, and 6 months post-baseline.
Secondary outcome [6] 373839 0
Depressive symptoms, measured using Beck's Depression Inventory
Timepoint [6] 373839 0
Baseline, 3 months post baseline, and 6 months post-baseline
Secondary outcome [7] 373840 0
Masculine depressive symptoms, measured using the Male Depression Risk Scale (MDRS).
Timepoint [7] 373840 0
Baseline, 3 months post baseline, and 6 months post-baseline
Secondary outcome [8] 373841 0
Body Mass Index, measured using the standard formula (kg/m2). Height will be measured at baseline using a calibrated stadiometer (stretch stature method).
Timepoint [8] 373841 0
Baseline, 3 months post-baseline,. and 6 months post-baseline.
Secondary outcome [9] 373844 0
Brachial blood pressure (systolic), measured with the Pulsecor Cardioscope II
Timepoint [9] 373844 0
Baseline, 3 months post-baseline, and 6 months post-baseline.
Secondary outcome [10] 373845 0
Arterial stiffness (augmentation index), measured with the Pulsecor Cardioscope II
Timepoint [10] 373845 0
Baseline, 3 months post-baseline, and 6 months post-baseline.
Secondary outcome [11] 373846 0
Resting pulse, measured with the Pulsecor Cardioscope II
Timepoint [11] 373846 0
Baseline, 3 months post-baseline and 6 months post-baseline
Secondary outcome [12] 373983 0
Cognitive Flexibility, measured using the Alternatives subscale from the Cognitive Flexibility Index.
Timepoint [12] 373983 0
Baseline, 3 months post-baseline and 6 months post-baseline
Secondary outcome [13] 373984 0
Mindful Attention, measured using the Mindful Attention Awareness Scale
Timepoint [13] 373984 0
Baseline, 3 months post-baseline and 6 months post-baseline
Secondary outcome [14] 373985 0
Behavioral Activation experiences, measured using the Behavioral Activation for Depression Scale.
Timepoint [14] 373985 0
Baseline, 3 months post-baseline and 6 months post-baseline
Secondary outcome [15] 374377 0
Body Fat %, measured using InBody720 bioimpedance machine.
Timepoint [15] 374377 0
Baseline, 3 months post-baseline, and 6 months post-baseline.
Secondary outcome [16] 374378 0
Average total kJ/day, measured using the online Australian Eating Survey.
Timepoint [16] 374378 0
Baseline, 3 months post-baseline, and 6 months post-baseline.
Secondary outcome [17] 374379 0
Fruit and vegetable serves/day, measured using the online Australian Eating Survey
Timepoint [17] 374379 0
Baseline, 3 months post-baseline, and 6 months post-baseline.
Secondary outcome [18] 374380 0
% Energy from Non-core Food, measured using the online Australian Eating Survey
Timepoint [18] 374380 0
Baseline, 3 months post-baseline, and 6 months post-baseline.
Secondary outcome [19] 374381 0
% time spent in moderate to vigorous physical activity, measured via one week of accelerometery with GT3x accelerometers
Timepoint [19] 374381 0
Baseline, 3 months post-baseline, and 6 months post-baseline.
Secondary outcome [20] 374382 0
% time spent in light physical activity, measured via one week of accelerometry using GT3x accelerometers.
Timepoint [20] 374382 0
Baseline, 3 months post-baseline, and 6 months post-baseline.
Secondary outcome [21] 374383 0
Total cholesterol (mmol/l), obtained from a fasting finger prick blood sample analysed using a CardioChek analyser and lipid panel test strips.
Timepoint [21] 374383 0
Baseline, 3 months post-baseline, and 6 months post-baseline.
Secondary outcome [22] 374384 0
HDL-Cholesterol (mmol/l), obtained from a fasting finger prick blood sample analysed using a CardioChek analyser and lipid panel test strips.
Timepoint [22] 374384 0
Baseline, 3 months post-baseline, and 6 months post-baseline.
Secondary outcome [23] 374385 0
LDL-Cholesterol (mmol/l), obtained from a fasting finger prick blood sample analysed using a CardioChek analyser and lipid panel test strips.
Timepoint [23] 374385 0
Baseline, 3 months post-baseline, and 6 months post-baseline.
Secondary outcome [24] 374386 0
Triglyceride (mmol/l), obtained from a fasting finger prick blood sample analysed using a CardioChek analyser and lipid panel test strips.
Timepoint [24] 374386 0
Baseline, 3 months post-baseline, and 6 months post-baseline.
Secondary outcome [25] 374387 0
Total cholesterol/HDL-C ratio, obtained from a fasting finger prick blood sample analysed using a CardioChek analyser and lipid panel test strips.
Timepoint [25] 374387 0
Baseline, 3 months post-baseline, and 6 months post-baseline.
Secondary outcome [26] 374388 0
Brachial blood pressure (diastolic), measured with the Pulsecor Cardioscope II
Timepoint [26] 374388 0
Baseline, 3 months post-baseline, and 6 months post-baseline
Secondary outcome [27] 374389 0
Perceived physical strength, measured using the Strength subscale of the Physical Self Perception Profile - short form.
Timepoint [27] 374389 0
Baseline, 3 months post-baseline, and 6 months post-baseline.
Secondary outcome [28] 374390 0
Perceived global physical self worth, measured using the Global Physical subscale of the Physical Self Perception Profile - short form.
Timepoint [28] 374390 0
Baseline, 3 months post-baseline, and 6 months post-baseline

Eligibility
Key inclusion criteria
- Male
- Aged 18-70 years old
- Overweight or obese (Body Mass Index of 25-42 kg/m2)
- Current depressive symptoms indicated by a PHQ-9 score greater than or equal to 5
- Own a computer, tablet or smartphone with internet access;
- Available to attend three assessment sessions at the University of Newcastle over 6 months.
Minimum age
18 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Serious risk of suicide
- Started a new antidepressant medication (or changed dose) in the past 4 weeks;
- Have had bariatric surgery in the past 12 months or plan to have the surgery during the study;
- Unable to speak, read or understand English;
- Planning to move out of the area during the study period;
- Currently participating (or plan to participate) in an alternative weight loss program;
- Not willing to be randomly allocated into either study group
- Lost 5% or more of body weight in the past 6 months.
- Does not pass a pre-exercise screening tool (or obtain a Dr’s clearance)

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 within the stratification categories (see sequence generation) 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. Study participants will complete all baseline assessments before proceeding to a separate room to meet with a study chief investigator who will not be involved in assessments. The allocation sequence will be concealed during this process. At this point, the participant will be allocated the next available envelope in their relevant stratification category. The chief investigator will then open the envelope and briefly provide to the participant with details on their group assignment using a standardised protocol. If the participant is randomised into the intervention group they will then provided with their program resources.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised at an individual level by an independent statistician who will not have any contact with participants during the trial. Allocation will be stratified by baseline BMI (less than 33 kg/m2, greater than or equal to 33 kg/m2), baseline depressive symptoms (PHQ score less than 10, PHQ score greater than or equal to 10), and whether the participant is taking anti-depressant medication (Y/N). The allocation sequence within strata will be generated by a computer-based random number-producing algorithm in randomly varied block lengths. 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 the statistician who generated the randomisation sequence and those who conceal allocation from those involved in implementation of group assignments.
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
Based on pilot data, 118 participants will provide 80% power to detect a 4 kg group-by-time difference in weight (baseline SD 14 kg, pre-post correlation 0.9) and a large standardised mean difference (Cohen’s d - 0.8) in depressive symptoms (MD 3.2 PHQ-9 units, baseline SD 4 units, pre-post correlation 0.5) at 3 months (primary endpoint).

Importantly, a 4 kg weight loss is associated with clinically meaningful improvements in multiple cardiovascular disease risk factors and our pilot data indicate that a 3.2 unit decrease in PHQ-9 score would move approximately 80% of men with depressive symptoms into a lower symptom severity bracket (e.g., moderate to mild). This power calculation includes an adjusted significance level (a = 0.025) to account for the dual primary outcomes, assumes 80% retention at 3 months, and provides adequate power to detect medium-sized mediation effects.

Intention to treat, linear mixed models will be used to examine the intervention effect on all continuous study outcomes compared with the wait-list control, adjusted for significant covariates. These models will assess all outcomes for the impact of group (intervention vs. control), time (categorical) and the group-by-time interaction.

Potential moderators of intervention effects for the study primary outcomes will be explored using interaction tests. Subgroup analyses will be conducted for the following variables if the significance of the group-by-moderator interaction is less than or equal to .10. Socio-economic status (SEIFA decile 1-5/6-10), baseline weight status (overweight/obese), baseline depressive symptoms (PHQ-9 <10/>=10), and if the participant was receiving mental health support at baseline (e.g., antidepressant medication and/or psychotherapy, Y/N).

As the analyses of secondary outcomes are intended to complement the primary outcome data and provide preliminary insights for future hypothesis testing, no multiplicity adjustments will be conducted. Given the exploratory nature of these secondary analyses, p values <0.05 will be interpreted as suggestive, rather than significant effects for these outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/09/2019
Actual
2/09/2019
Date of last participant enrolment
Anticipated
20/09/2019
Actual
20/09/2019
Date of last data collection
Anticipated
20/03/2020
Actual
24/03/2020
Sample size
Target
118
Accrual to date
Final
125
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303265 0
Other Collaborative groups
Name [1] 303265 0
Hunter Medical Research Institute (HMRI)
Country [1] 303265 0
Australia
Funding source category [2] 303331 0
Commercial sector/Industry
Name [2] 303331 0
Daracon Group
Country [2] 303331 0
Australia
Funding source category [3] 303332 0
Charities/Societies/Foundations
Name [3] 303332 0
National Heart Foundation of Australia
Country [3] 303332 0
Australia
Funding source category [4] 303333 0
University
Name [4] 303333 0
University of Newcastle
Country [4] 303333 0
Australia
Primary sponsor type
Individual
Name
Dr Myles Young
Address
School of Education
University of Newcastle
University Drive
Callaghan NSW 2308
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 303622 0
None
Name [1] 303622 0
Address [1] 303622 0
Country [1] 303622 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303803 0
The University of Newcastle Human Research Ethics Committee (HREC)
Ethics committee address [1] 303803 0
Ethics committee country [1] 303803 0
Australia
Date submitted for ethics approval [1] 303803 0
19/02/2019
Approval date [1] 303803 0
30/07/2019
Ethics approval number [1] 303803 0
H-2019-0047

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

Contacts
Principal investigator
Name 94866 0
Dr Myles Young
Address 94866 0
Priority Research Centre in Physical Activity and Nutrition,
University of Newcastle,
University Drive, Callaghan, NSW, 2308
Country 94866 0
Australia
Phone 94866 0
+61 2 49 216 096
Fax 94866 0
Email 94866 0
myles.young@newcastle.edu.au
Contact person for public queries
Name 94867 0
Myles Young
Address 94867 0
Priority Research Centre in Physical Activity and Nutrition,
University of Newcastle,
University Drive, Callaghan, NSW, 2308
Country 94867 0
Australia
Phone 94867 0
+61 2 49 216 096
Fax 94867 0
Email 94867 0
myles.young@newcastle.edu.au
Contact person for scientific queries
Name 94868 0
Myles Young
Address 94868 0
Priority Research Centre in Physical Activity and Nutrition,
University of Newcastle,
University Drive, Callaghan, NSW, 2308
Country 94868 0
Australia
Phone 94868 0
+61 2 49 216 096
Fax 94868 0
Email 94868 0
myles.young@newcastle.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseMechanisms of an eHealth program targeting depression in men with overweight or obesity: A randomised trial.2022https://dx.doi.org/10.1016/j.jad.2021.12.001
N.B. These documents automatically identified may not have been verified by the study sponsor.