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Contemp Clin Trials. 2014 Sep;39(1):132-44. doi: 10.1016/j.cct.2014.07.008. Epub 2014 Aug 1.

The PULSE (Prevention Using LifeStyle Education) trial protocol: a randomised controlled trial of a Type 2 Diabetes Prevention programme for men.

Author information

1
Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia; School of Biomedical Sciences and Pharmacy, Faculty of Health and Medicine, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia. Electronic address: Elroy.Aguiar@newcastle.edu.au.
2
Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia; School of Education, Faculty of Education and Arts, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia. Electronic address: Philip.Morgan@newcastle.edu.au.
3
Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia; School of Health Sciences, Faculty of Health and Medicine, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia. Electronic address: Clare.Collins@newcastle.edu.au.
4
Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia; School of Education, Faculty of Education and Arts, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia. Electronic address: Ron.Plotnikoff@newcastle.edu.au.
5
Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia; School of Education, Faculty of Education and Arts, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia. Electronic address: Myles.Young@newcastle.edu.au.
6
Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia; School of Biomedical Sciences and Pharmacy, Faculty of Health and Medicine, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia. Electronic address: Robin.Callister@newcastle.edu.au.

Abstract

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.

TRIAL REGISTRATION:

Australian New Zealand Clinical Trials Registry (ACTRN12612000721808).

KEYWORDS:

Diet; Exercise; Prevention; Resistance training; Type 2 diabetes; Weight loss

PMID:
25092484
DOI:
10.1016/j.cct.2014.07.008
[Indexed for MEDLINE]
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