None listed
Conditions
Brief summary
Depression and obesity in men are two of the largest public health concerns in Australia. These conditions also appear to be linked as men with overweight or obesity are ~30% more likely to develop depression than healthy weight men. Furthermore, men with depression are 43% more likely to develop obesity than men without depression. The SHED-IT: Recharge randomised trial (ACTRN12619001209189) tested a self-guided eHealth program combining lifestyle behaviour change advice and mental health support to reduce depression (and weight status) in men. It was the first RCT of an integrated mental and physical health intervention for men with depression. Results indicated significant and clinically meaningful intervention effects on both depressive symptoms and weight loss at post-intervention compared to the control group, which was maintained at 6-month follow up. However, because the program targeted physical and mental health it was unclear which components were most important for driving changes in the men's depressive symptoms. As such, the purpose of this pilot trial is the examine the feasibility and preliminary efficacy of comparing an online program focused only on lifestyle behaviour change to an online program focused only on mental health support for men with depression and overweight or obesity.
Interventions
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 mater
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.
Sponsors
Dr Myles Young
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 70 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed