None listed
Conditions
Brief summary
The Type 2 Diabetes PULSE (Prevention Using LifeStyle Education) study, is a 6 month research study evaluating the effectiveness of a men only Type 2 Diabetes prevention study that focuses on diet and home-based exercise (aerobic and resistance exercise). Aims: To determine the feasibility and efficacy of a novel multi-component Type 2 Diabetes prevention program (diet + aerobic exercise + resistance exercise) Hypotheses: 1. Compared to the wait-list control, the diet + aerobic training + RT intervention will result in a significant and a clinically meaningful reduction in weight as well as improvements in important secondary outcomes such as plasma biomarkers at 3 and 6 months post-baseline. The Type 2 Diabetes PULSE intervention will consist of a diet and exercise (aerobic and resistance training) program. Men in the intervention group will receive a resource pack with information regarding Type 2 Diabetes prevention. The dietary intervention will consist of a resource manual with information/tips to improve diet quality and reduce Type 2 Diabetes risk such reducing overall energy intake, reading food labels, reducing portion size, reducing alcohol and sugared beverages, improving quality of diet (low GI carbohydrates, high fibre, low saturated fat), achieving an ideal macronutrient (carbohydrates-fat-protein) profile, reducing salt intake, and increasing fruit and vegetable intake. The exercise intervention will consist of both aerobic and resistance training and will be self-administered over the duration of the 6-month intervention. Men will be asked to perform at least 150 mins/wk (5 x 30 min sessions) of moderate intensity aerobic exercise (e.g., walking, jogging, swimming, cycling) and at least 60 mins/wk (2 x 30 min sessions) of resistance training using body weight and Gymstick (an elastic tubing) exercises. Men will be assessed at baseline, 3- and 6-months on a range of health outcomes. Primary outcomes for the study are weight and fasting plasma glucose. Secondary outcomes will include anthropometric, plasma biomarker, and diet and exercise/fitness measures. The wait-list control group will receive the intervention after the 6-month time-point and will be followed up for a further 6 months.
Interventions
A 6-month randomised controlled trial of a novel Type 2 Diabetes prevention intervention: The Type 2 Diabetes PULSE study - Prevention Using Lifestyle Education.
The Type 2 Diabetes PULSE intervention will consist of a diet and exercise (aerobic and resistance training) program. Men in the intervention group will receive a resource pack with information regarding Type 2 Diabetes prevention.
The dietary intervention will consist of a resource manual with information/tips to improve diet quali
A 6-month randomised controlled trial of a novel Type 2 Diabetes prevention intervention: The Type 2 Diabetes PULSE study - Prevention Using Lifestyle Education. The Type 2 Diabetes PULSE intervention will consist of a diet and exercise (aerobic and resistance training) program. Men in the intervention group will receive a resource pack with information regarding Type 2 Diabetes prevention. The dietary intervention will consist of a resource manual with information/tips to improve diet quality and reduce Type 2 Diabetes risk such reducing overall energy intake, reading food labels, reducing portion size, reducing alcohol and sugared beverages, improving quality of diet (low GI carbohydrates, high fibre, low saturated fat), achieving an ideal macronutrient (carbohydrates-fat-protein) profile, reducing salt intake, and increasing fruit and vegetable intake. The participants will be asked to enter their dietary intake into a food and exercise diary (www.calorieking.com.au). The participants will not be prescribed a specific diet or meal plan. The exercise intervention will consist of both aerobic and resistance training and will be self-administered over the duration of the 6-month intervention. Men will be asked to perform at least 150 mins/wk (5 x 30 min sessions) of moderate intensity aerobic exercise (e.g., walking, jogging, swimming, cycling) and at least 60 mins/wk (2 x 30 min sessions) of resistance training using body weight and Gymstick (an elastic tubing) exercises. The exercise resource manual will provide thorough instruction on how to safely perform the exercise. Participants will also receive an instruction video demonstrating the technique of the prescribed Gymstick and bodyweight exercises. These exercises will be conducted in their homes and will not be supervised. The participants will be also be asked to record the amount of exercise they do in an exercise log book and also into a food and exercise diary (www.calorieking.com.au) Men will be assessed at baseline, 3- and 6-months on a range of health outcomes. Primary outcomes for the study are weight and fasting plasma glucose. Secondary outcomes will include anthropometric, plasma biomarker, and diet and exercise/fitness measures. The wait-list control group will receive the intervention after the 6-month time-point and will be followed up for a further 6 months.
Sponsors
Professor Robin Callister
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria - Aged 18-65 years - Overweight or obese men with a body mass index (BMI) between 25 and 40 kg/m2 - An AUSDRISK score of >12 i.e., high risk - Obtained a GP clearance if required confirming they are able to participate in a diet and exercise program - Agree to not participate in other weight loss programs during the study - Pass a health-screening questionnaire - Available for assessment sessions - Have access to a computer with e-mail and Internet facilities
Exclusion criteria
Exclusion criteria - Have T2D or a history of major medical problems such as heart disease - Have orthopaedic or joint problems that would be a barrier to physical activity such as walking, running and resistance training - Recently lost 5 kg or more in weight - Are taking medications that might be affected by weight loss or affect weight loss or glucose tolerance/insulin sensitivity
Outcome results
None listed