None listed
Conditions
Brief summary
Obesity is now the most important avoidable cause of ill health in Australia today. Obesity is an independent risk factor for cardiovascular disease (CVD) and a major cause of preventable death. In Australia, 67% of men are considered to be overweight or obese compared to 52% of women, yet men are less likely to attempt weight loss than women. Men are notoriously difficult to recruit to weight loss programs, despite being more susceptible to many of the serious consequences such as CVD. Overweight men have greater abdominal adiposity than women, which is associated with increased risk of CVD. There is an urgent need to develop and evaluate novel and cost effective approaches to weight loss that engage large numbers of men. The primary aim of the current study is to explore the efficacy of two SHED-IT behavioural intervention strategies developed specifically for men and involving different modes of delivery in a large community weight loss trial. Key secondary objectives include: - Determine the relative benefit of two different weight loss programs (Resources and Online) designed to be incremental in extent of interaction & intensity of intervention on weight and other health outcomes; - Evaluate strategies to improve adherence to online programs and examine what attributes of individuals and website features may predict compliance; - Determine the characteristics of men for which each program is most effective; - Compare the effects of the different programs in defined subgroups (age, education, occupation, marital status, SES). It is hypothesised that: (1) Compared to baseline, both the SHED-IT Resources and Online interventions will result in a clinically important and statistically significant (a) reduction in weight and (b) improvement in other important secondary outcome measures; at 3 and 6 months post-baseline (2) The Online intervention, compared to the Resources Intervention, will result in greater improvements in primary and secondary outcomes at 3 and 6 months post-baseline. RESEARCH PLAN Study design: Assessor-blinded randomised controlled trial. Men randomised to one of three study arms: (i) Resources (ii) Online (iii) Wait list. Participants - Overweight/obese men (BMI >25 <40kg/m2) aged 18 to 65 years. Intervention Descriptions: (i) WL Resources (Information and self-help control) resource package includes: DVD on weight loss in men; program booklet; calorie counter. (ii) WL Online (Basic + Internet behavioural therapy): ‘WL Basic’ resources plus access to study website; website user manual; individualised online feedback. Outcomes: At baseline, 3- and 6-months: weight, waist circumference, BMI, fat free mass, dietary intake (FFQ), physical activity (pedometers), sedentary behaviours, blood pressure, perceived physical/mental health (SF-12), demographics & SES. Analysis: Linear mixed models to assess all outcomes for the impact of treatment, time and the treatment by time interaction, with these three terms forming the base model.
Interventions
The duration of the intervention is 3 months. Participants will be randomised to one of three groups (i) SHED-IT Resources only (ii) SHED-IT Online and Resources or (iii) waitlist control group. All participants in the resources group will be sent a DVD with a presentation on weight loss for men; two program booklets - The Weight Loss Handbook for Blokes and The Weight Loss Support Book for Blokes; a calorie counter book; a pedometer and tape measure with instructions for use. The DVD will cov
The duration of the intervention is 3 months. Participants will be randomised to one of three groups (i) SHED-IT Resources only (ii) SHED-IT Online and Resources or (iii) waitlist control group. All participants in the resources group will be sent a DVD with a presentation on weight loss for men; two program booklets - The Weight Loss Handbook for Blokes and The Weight Loss Support Book for Blokes; a calorie counter book; a pedometer and tape measure with instructions for use. The DVD will cover weight control instruction relating to diet, physical activity and behaviour change strategies aligned with Bandura's Social Learning Theory (aka Social Cognitive Theory). Participants in the online group will receive resources as above plus additional behavioural support over the course of the 3 months via use of the online website www.calorieking.com.au. This website reinforces the key strategies of self monitoring, goal setting and social support. The website allows submission of self-monitored energy expenditure and intake, weight and online group support. Participants will be instructed to submit at least 4 daily diaries per week for 3 months. Their diaries will be reviewed (weekly in the 1st month; fortnightly in the 2nd month and monthly thereafter) and individualised feedback provided in the key areas of weight loss; diet (kilojoule intake, saturated fat, sodium and fibre) and physical activity (frequency, intensity, type and time). Participants can email the research team with questions. The waitlist control group will be randomised to either SHED-IT resources only or SHED-IT Online and Resources immediately following the 6 month follow-up assessment
Sponsors
Professor Philip Morgan
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
Yes
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