None listed
Conditions
Brief summary
Obesity in men is one of the greatest public health challenges facing Australia. Obesity is an independent risk factor for cardiovascular disease (CVD) and a major cause of preventable death and disability. With 70% of Australian men overweight or obese, the current and predicted financial and human costs are alarming. Despite men being more susceptible than women to many of the serious consequences of obesity such as CVD, men rarely engage in weight loss (WL) programs, and when they do lose weight they rarely maintain the WL. There is an urgent need to develop and evaluate novel and cost effective approaches that achieve long-term WL in men. The aim of this pilot study is to develop and evaluate the feasibility and efficacy of a WL maintenance (WLM) program specifically for men.
Interventions
This study contains two distinct phases.
Phase I: A 3-month Weight Loss (WL) phase
All men in the study will receive a WL tool kit which has been developed and extensively tested in our pilot research. The SHED-IT WL Program includes:
1.The ‘SHED-IT WL DVD for Blokes’
2.The ‘SHED-IT WL Handbook for Blokes’
3.The ‘SHED-IT WL Log Book for Blokes'
4. Tools (pedometer, tape measure and kJ counter book).
Men will also be advised to self-monitor their food and exercise diary 4 days each week and
This study contains two distinct phases. Phase I: A 3-month Weight Loss (WL) phase All men in the study will receive a WL tool kit which has been developed and extensively tested in our pilot research. The SHED-IT WL Program includes: 1.The ‘SHED-IT WL DVD for Blokes’ 2.The ‘SHED-IT WL Handbook for Blokes’ 3.The ‘SHED-IT WL Log Book for Blokes' 4. Tools (pedometer, tape measure and kJ counter book). Men will also be advised to self-monitor their food and exercise diary 4 days each week and record their weight weekly. Men will receive weekly text messages to reinforce key behaviours for weight loss and to target the hypothesised cognitive and behavioural mediators of behaviour change outlined in Social Cognitive Theory (e.g. self efficacy, social support). Phase II: A 36-month Weight Loss Maintenance (WLM) phase (6-month WLM Program + additional 30 months of unsupervised follow-up) The 'baseline' assessment for this RCT will occur at the beginning of Phase II (i.e. 3 months after the commencement of the weight loss program in Phase I). At this assessment, all men who have lost at least 4 kg during Phase I will be randomised to either a self-help control group (see comparator / control treatment below) or a WLM group. Men who have not lost at least 4 kg will not be eligible for Phase II of this study. The WLM group will receive the SHED-IT WLM program, which is a six month program that includes: 1. 'The SHED-IT WLM DVD for Blokes' 2. 'The SHED-IT WLM Handbook for Blokes' 3. 'The SHED-IT WLM Logbook for Blokes' 4. A Gymstick (portable, elastic tubing resistance training device). 5. Access to the weekly SHED-IT WLM Online Blog Men will be advised to engage with the resources at their discretion and to check in with the WLM Blog weekly. A gymstick manual will be provided to men, but the intervention will not involve a specified resistance training program. However men will be advised to aim for at least 300 minutes per week of moderate physical activity. Men will also be encouraged to continue self-monitoring their food and exercise 2 days per week and to record their weight each week. Men will receive fortnightly text messages to reinforce key behaviours for weight loss maintenance and to target the hypothesised cognitive and behavioural mediators of behaviour change outlined in Social Cognitive Theory (e.g. self efficacy, social support).
Sponsors
Prof. Philip Morgan
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Overweight or obese men (BMI between 25 and 40 kg/[m2])
Exclusion criteria
History of major medical problems such as heart disease in the last 5 years, Insulin-Dependent Diabetes Mellitus (IDDM), or orthopaedic or joint problems that would be a barrier to physical activity. Participants with recent weight loss of 5% of total body mass or more or who are taking medications that might be affected by weight loss or participating in other weight loss programs or without internet access will also be excluded.
Outcome results
None listed