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 who are overweight or obese 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. Behavioural weight loss programs have shown promise to reduce depressive symptoms and improve weight status in people who are overweight or obese, but few interventions have engaged men and most have included components that are not scalable (e.g., intensive face-to-face support). E-health programs targeting men’s physical and mental health may represent a more scalable solution to these concerns, but the evidence-base supporting their efficacy is limited. Primary aim: To develop and test the efficacy of a gender-tailored, e-health weight loss program (SHED-IT: Recharge) to improve the physical and mental health of overweight and obese men with elevated depressive symptoms. Primary hypothesis: Men in the SHED-IT: Recharge group will show greater improvements in i) weight and ii) depressive symptoms at 3 months post-baseline, compared to a wait-list control group. Secondary aim 1: To determine the effect of SHED-IT: Recharge on men’s weight and depressive symptoms at 6 month follow-up. Secondary aim 2: To determine the effect of SHED-IT: Recharge on a range of lifestyle health behaviours (e.g., physical activity, dietary habits), mental health outcomes (e.g., anxiety) and other health indicators (e.g., blood pressure, blood lipids). Secondary aim 3: To identify which behavioural changes (e.g., diet, sleep) result in the largest, independent contributions toward the overall intervention effect on weight and depressive symptoms.
Interventions
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 eH
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.
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
- 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.
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)
Outcome results
None listed