- Title
- The PULSE (Prevention Using LifeStyle Education) trial protocol: a randomised controlled trial of a Type 2 Diabetes Prevention programme for men.
- Creator
- Aguiar, Elroy J.; Morgan, Philip J.; Collins, Clare E.; Plotnikoff, Ronald C.; Young, Myles D.; Callister, Robin
- Relation
- Contemporary Clinical Trials Vol. 39, Issue 1, p. 132-144
- Publisher Link
- http://dx.doi.org/10.1016/j.cct.2014.07.008
- Publisher
- Elsevier
- Resource Type
- journal article
- Date
- 2014
- Description
- Background: Intensive lifestyle interventions have been successful in reducing type 2 diabetes incidence. Whether intensive programmes requiring face-to-face contact, trained staff and access to facilities are feasible, on a larger scale, has been debated. Objectives: The aim of this study is to determine the feasibility and efficacy of a lifestyle intervention for type 2 diabetes prevention in men using an assessor-blinded, parallel-group, randomised controlled trial. The 'Type 2 Diabetes PULSE (Prevention Using LifeStyle Education) Programme for Men' is a 6-month, self-administered, gender-tailored lifestyle intervention, with a multicomponent approach (weight loss, dietary modification, aerobic exercise and resistance training). Eligible men were aged 18-65 years, overweight/obese (BMI 25-40 kg m(-2)) and at high-risk for type 2 diabetes (score = 12, Australian diabetes risk tool). Men with diagnosed prediabetes were eligible, but those with type 1 and 2 diabetes were ineligible. Randomisation was stratified by age (<50 or = 50 years) and BMI category (kg m(-2): 25-29.9; 30-34.9; 35-40) to the intervention or wait-list control group. Data are collected at study entry (baseline), 3 and 6 months. The primary outcome is weight change at 6 months. Secondary outcomes include: fasting plasma glucose, HbA1C, waist circumference, body composition, blood pressure, diet quality, aerobic fitness, muscular fitness and physical activity. Generalised linear mixed models (intention-to-treat) will assess outcomes for treatment (intervention vs. control), time (baseline, 3 and 6-months) and the treatment-by-time interaction. Conclusion: The results will determine the efficacy of a type 2 diabetes prevention programme for men with potential for wide reach and dissemination.
- Subject
- type 2 diabetes; prevention; diet; exercise; resistance training; weight loss
- Identifier
- http://hdl.handle.net/1959.13/1054589
- Identifier
- uon:15776
- Identifier
- ISSN:1551-7144
- Language
- eng
- Full Text
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