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

Contemporary Clinical Trials

Volumn 39, Issue 1, 2014, Pages 132-144

  Aguiar, Elroy J ^a,b   Morgan, Philip J ^a,b   Collins, Clare E ^a,b   Plotnikoff, Ronald C ^a,b   Young, Myles D ^a,b   Callister, Robin ^a,b  

^a UNIVERSITY OF NEWCASTLE   (Australia)

^b UNIVERSITY OF NEWCASTLE   (Australia)

Author keywords

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

Indexed keywords

ALANINE AMINOTRANSFERASE; ALBUMIN; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; GLOBULIN; GLUCOSE; HEMOGLOBIN A1C; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; INSULIN; LOW DENSITY LIPOPROTEIN CHOLESTEROL; URATE; CARBOHYDRATE; GAMMA GLUTAMYLTRANSFERASE; POLYUNSATURATED FATTY ACID; PROTEIN; TRIACYLGLYCEROL; GLUCOSE BLOOD LEVEL; GLYCOSYLATED HEMOGLOBIN;

ADULT; AEROBIC EXERCISE; AGED; ALCOHOL CONSUMPTION; ARTICLE; BEHAVIOR CHANGE; BLOOD PRESSURE; BODY COMPOSITION; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; DIET; DIET RESTRICTION; DIETARY INTAKE; FITNESS; FOLLOW UP; GLUCOSE BLOOD LEVEL; HEALTH BEHAVIOR; HEALTH EDUCATION; HEALTH PROGRAM; HEMOGLOBIN BLOOD LEVEL; HIGH RISK POPULATION; HUMAN; IMPAIRED GLUCOSE TOLERANCE; INTERVENTION STUDY; ISOMETRIC EXERCISE; LIFESTYLE MODIFICATION; MAJOR CLINICAL STUDY; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; OBESITY; OUTCOME ASSESSMENT; PARALLEL DESIGN; PHYSICAL ACTIVITY; PORTION SIZE; PROGRAM FEASIBILITY; PSYCHOLOGICAL WELL BEING; QUALITY OF LIFE; QUANTITATIVE INSULIN SENSITIVITY CHECK INDEX; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RESISTANCE TRAINING; SINGLE BLIND PROCEDURE; WAIST CIRCUMFERENCE; WEIGHT CHANGE; WEIGHT REDUCTION; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; BODY MASS; CARBOHYDRATE INTAKE; CHOLESTEROL BLOOD LEVEL; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; INSULIN DEPENDENT DIABETES MELLITUS; PROTEIN INTAKE; RANGE OF MOTION; REIMBURSEMENT; RESTING HEART RATE; ADOLESCENT; AGE; AUSTRALIA; DIABETES MELLITUS, TYPE 2; EXERCISE; LIFESTYLE; MIDDLE AGED; MORPHOMETRICS; OVERWEIGHT; PROCEDURES; RISK FACTOR; SOCIOECONOMICS; WEIGHT LOSS PROGRAM; YOUNG ADULT;

ADOLESCENT; ADULT; AGE FACTORS; AGED; AUSTRALIA; BLOOD GLUCOSE; BODY MASS INDEX; BODY WEIGHTS AND MEASURES; DIABETES MELLITUS, TYPE 2; DIET; EXERCISE; HEALTH BEHAVIOR; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; LIFE STYLE; MALE; MIDDLE AGED; OBESITY; OVERWEIGHT; QUALITY OF LIFE; RISK FACTORS; SINGLE-BLIND METHOD; SOCIOECONOMIC FACTORS; WEIGHT REDUCTION PROGRAMS; YOUNG ADULT;

EID: 84926158276     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2014.07.008     Document Type: Article

References (77)

1. IDF diabetes atlas 2013, International Diabetes Federation, Brussels, Belgium. 6th ed.
2. Alberti K., Zimmet P., Shaw J. International diabetes federation: a consensus on type 2 diabetes prevention. Diabet Med 2007, 24:451-463. 10.1111/j.1464-5491.2007.02157.x.
3. Knowler W.C., Barrett-Connor E., Fowler S.E., Hamman R.F., Lachin J.M., Walker E.A., et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002, 346:393-403. 10.1056/NEJMoa012512.
4. Lindstrom J., Louheranta A., Mannelin M., Rastas M., Salminen V., Eriksson J., et al. The Finnish Diabetes Prevention Study (DPS): lifestyle intervention and 3-year results on diet and physical activity. Diabetes Care 2003, 26(12):3230-3236. 10.2337/diacare.26.12.3230.
5. Eddy D.M., Schlessinger L., Kahn R. Clinical outcomes and cost-effectiveness of strategies for managing people at high risk for diabetes. Ann Intern Med 2005, 143:251-264. 10.7326/0003-4819-143-4-200508160-00006.
6. Dunkley A.J., Bodicoat D.H., Greaves C.J., Russell C., Yates T., Davies M.J., et al. Diabetes prevention in the real world: effectiveness of pragmatic lifestyle interventions for the prevention of type 2 diabetes and of the impact of adherence to guideline recommendations: a systematic review and meta-analysis. Diabetes Care 2014, 37:922-933. 10.2337/dc13-2195.
7. Bray G.A., Culbert I.W., Champagne C.M., Dawson L., Eberhardt B., Greenway F.L., et al. The diabetes prevention program - design and methods for a clinical trial in the prevention of type 2 diabetes. Diabetes Care 1999, 22:623-634. 10.2337/diacare.22.4.623.
8. Herman W.H., Brandle M., Zhang P., Williamson D.F., Matulik M.J., Ratner R.E., et al. Costs associated with the primary prevention of type 2 diabetes mellitus in the diabetes prevention program. Diabetes Care 2003, 26:36-47. 10.2337/diacare.26.1.36.
9. Morgan P.J., Callister R., Collins C.E., Plotnikoff R.C., Young M.D., Berry N., et al. The SHED-IT community trial: a randomized controlled trial of internet- and paper-based weight loss programs tailored for overweight and obese men. Ann Behav Med 2013, 45:139-152. 10.1007/s12160-012-9424-z.
10. Eves N.D., Plotnikoff R.C. Resistance training and type 2 diabetes: considerations for implementation at the population level. Diabetes Care 2006, 29:1933-1941. 10.2337/dc05-1981.
11. Dunstan D.W., Daly R.M., Owen N., Jolley D., Vulikh E., Shaw J., et al. Home-based resistance training is not sufficient to maintain improved glycemic control following supervised training in older individuals with type 2 diabetes. Diabetes Care 2005, 28:3-9. 10.2337/diacare.28.1.3.
12. Schwarz P.E., Greaves C.J., Lindstrom J., Yates T., Davies M.J. Nonpharmacological interventions for the prevention of type 2 diabetes mellitus. Nat Rev Endocrinol 2012, 8:363-373. 10.1038/nrendo.2011.232.
13. Pagoto S.L., Schneider K.L., Oleski J.L., Luciani J.M., Bodenlos J.S., Whited M.C. Male inclusion in randomized controlled trials of lifestyle weight loss interventions. Obesity (Silver Spring) 2012, 20:1234-1239. 10.1038/oby.2011.140.
14. Aguiar E.J., Morgan P.J., Collins C.E., Plotnikoff R.C., Callister R. Efficacy of interventions that include diet, aerobic and resistance training components for type 2 diabetes prevention: a systematic review with meta-analysis. Int J Behav Nutr Phys Act 2014, 11. 10.1186/1479-5868-11-2.
15. Schulz K.F., Altman D.G., Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 2010, 152:726-732. 10.7326/0003-4819-152-11-201006010-00232.
16. Moher D., Hopewell S., Schulz K.F., Montori V., Gotzsche P.C., Devereaux P.J., et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010, 340:c869. 10.1136/bmj.c869.
17. Australian Government: Department of Health and Ageing The Australian type 2 diabetes risk assessment tool (AUSDRISK) 2010, [Canberra].
18. Norton K., Norton L. Pre-exercise screening: guide to the Australian adult pre-exercise screening system 2011, Exercise and Sports Science Australia/Fitness Australia/Sports Medicine Australia, Adelaide.
19. Lovejoy J.C., Sainsbury A. Sex differences in obesity and the regulation of energy homeostasis. Obes Rev 2009, 10:154-167. 10.1111/j.1467-789X.2008.00529.x.
20. Young M.D., Morgan P.J., Plotnikoff R.C., Callister R., Collins C.E. Effectiveness of male-only weight loss and weight loss maintenance interventions: a systematic review with meta-analysis. Obes Rev 2012, 13:393-408. 10.1111/j.1467-789X.2011.00967.x.
21. Morgan P.J., Warren J.M., Lubans D.R., Collins C.E., Callister R. Engaging men in weight loss: experiences of men who participated in the male only SHED-IT pilot study. Obes Res Clin Pract 2011, 5:e239-e248. 10.1016/j.orcp.2011.03.002.
22. Morgan P.J., Collins C.E., Plotnikoff R.C., Cook A.T., Berthon B., Mitchell S., et al. Efficacy of a workplace-based weight loss program for overweight male shift workers: the Workplace POWER (Preventing Obesity Without Eating like a Rabbit) randomized controlled trial. Prev Med 2011, 52:317-325. 10.1016/j.ypmed.2011.01.031.
23. Morgan P.J., Lubans D.R., Collins C.E., Warren J.M., Callister R. 12-Month outcomes and process evaluation of the SHED-IT RCT: an internet-based weight loss program targeting men. Obesity (Silver Spring) 2011, 19:142-151. 10.1038/oby.2010.119.
24. Morgan P.J., Lubans D.R., Callister R., Okely A.D., Burrows T.L., Fletcher R., et al. The 'Healthy Dads, Healthy Kids' randomized controlled trial: efficacy of a healthy lifestyle program for overweight fathers and their children. Int J Obes (Lond) 2011, 35:436-447. 10.1038/ijo.2010.151.
25. International Diabetes Federation IDF education modules 2011, International Diabetes Federation, Brussels, Belgium.
26. American Diabetes Association Nutrition Recommendations and Interventions for Diabetes: a position statement of the American Diabetes Association. Diabetes Care 2007, 30(Suppl. 1):S48-65. 10.2337/dc07-S048.
27. Morgan P.J., Collins C.E., Plotnikoff R.C., McElduff P., Burrows T., Warren J.M., et al. The SHED-IT community trial study protocol: a randomised controlled trial of weight loss programs for overweight and obese men. BMC Public Health 2010, 10:701. 10.1186/1471-2458-10-701.
28. Morgan P.J., Lubans D.R., Collins C.E., Warren J.M., Callister R. The SHED-IT randomized controlled trial: evaluation of an Internet-based weight-loss program for men. Obesity (Silver Spring) 2009, 17:2025-2032. 10.1038/oby.2009.85.
29. National Health and Medical Research Council Australian dietary guidelines 2013, National Health and Medical Research Council, Canberrra.
30. Colberg S.R., Sigal R.J., Fernhall B., Regensteiner J.G., Blissmer B.J., Rubin R.R., et al. Exercise and type 2 diabetes: the American College of Sports Medicine and the American Diabetes Association: joint position statement executive summary. Diabetes Care 2010, 33:2692-2696. 10.2337/dc10-1548.
31. Hordern M.D., Dunstan D.W., Prins J.B., Baker M.K., Singh M.A., Coombes J.S. Exercise prescription for patients with type 2 diabetes and pre-diabetes: a position statement from Exercise and Sport Science Australia. J Sci Med Sport 2012, 15:25-31. 10.1016/j.jsams.2011.04.005.
32. Nutrient reference values for Australia and New Zealand including recommended dietary intakes 2006, Australian National Health and Medical Research Council (NHMRC) and the New Zealand Ministry of Health (MoH).
33. Hamman R.F., Wing R.R., Edelstein S.L., Lachin J.M., Bray G.A., Delahanty L., et al. Effect of weight loss with lifestyle intervention on risk of diabetes. Diabetes Care 2006, 29:2102-2107. 10.2337/dc06-0560.
34. Borushek A. Calorie fat and carbohydrate counter 2012, Family Health Publications, Nedlands, Western Australia.
35. Young M.D., Collins C.E., Callister R., Plotnikoff R.C., Doran C.M., Morgan P.J. The SHED-IT weight loss maintenance trial protocol: a randomised controlled trial of a weight loss maintenance program for overweight and obese men. Contemp Clin Trials 2013, 10.1016/j.cct.2013.11.004.
36. Morgan P.J., Collins C.E., Plotnikoff R.C., Callister R., Burrows T., Fletcher R., et al. The 'Healthy Dads, Healthy Kids' community randomized controlled trial: a community-based healthy lifestyle program for fathers and their children. Prev Med 2013, 61C:90-99. 10.1016/j.ypmed.2013.12.019.
37. Bandura A. Social foundations of thought and action: a social cognitive theory 1986, Prentice-Hall, Englewood Cliffs, NJ.
38. Bandura A. Health promotion by social cognitive means. Health Educ Behav 2004, 31:143-164. 10.1177/1090198104263660.
39. Michie S., Richardson M., Johnston M., Abraham C., Francis J., Hardeman W., et al. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med 2013, 46:81-95. 10.1007/s12160-013-9486-6.
40. Morgan P.J., Scott H.A., Young M.D., Plotnikoff R.C., Collins C.E., Callister R. Associations between program outcomes and adherence to social cognitive theory tasks: process evaluation of the SHED-IT community weight loss trial for men. Int J Behav Nutr Phys Act 2014, 11:89. 10.1186/s12966-014-0089-9.
41. Resnicow K., Baranowski T., Ahluwalia J.S., Braithwaite R.L. Cultural sensitivity in public health: defined and demystified. Ethn Dis 1999, 9:10-21.
42. Hankey C.R., Leslie W.S., Lean M.E. Why lose weight? Reasons for seeking weight loss by overweight but otherwise healthy men. Int J Obes Relat Metab Disord 2002, 26:880-882. 10.1038/sj.ijo.0801999.
43. Dionigi R. Resistance training and older adults' beliefs about psychological benefits: the importance of self-efficacy and social interaction. J Sport Exerc Psychol 2007, 29:723-746.
44. Smith J.A., Braunack-Mayer A.J., Wittert G.A., Warin M.J. Qualities men value when communicating with general practitioners: implications for primary care settings. Med J Aust 2008, 189:618-621.
45. Baldi J.C., Snowling N. Resistance training improves glycaemic control in obese type 2 diabetic men. Int J Sports Med 2003, 24:419-423. 10.1055/s-2003-41173.
46. Black L.E., Swan P.D., Alvar B.A. Effects of intensity and volume on insulin sensitivity during acute bouts of resistance training. J Strength Cond Res 2010, 24:1109-1116. 10.1519/JSC.0b013e3181cbab6d.
47. Bweir S., Al-Jarrah M., Almalty A.M., Maayah M., Smirnova I.V., Novikova L., et al. Resistance exercise training lowers HbA1C more than aerobic training in adults with type 2 diabetes. Diabetol Metab Syndr 2009, 1:27. 10.1186/1758-5996-1-27.
48. Castaneda C., Layne J.E., Munoz-Orians L., Gordon P.L., Walsmith J., Foldvari M., et al. A randomized controlled trial of resistance exercise training to improve glycemic control in older adults with type 2 diabetes. Diabetes Care 2002, 25:2335-2341. 10.2337/diacare.25.12.2335.
49. Church T.S., Blair S.N., Cocreham S., Johannsen N., Johnson W., Kramer K., et al. Effects of aerobic and resistance training on hemoglobin A1c levels in patients with type 2 diabetes: a randomized controlled trial. JAMA 2010, 304:2253-2262. 10.1001/jama.2010.1710.
50. Dunstan D.W., Daly R.M., Owen N., Jolley D., De Courten M., Shaw J., et al. High-intensity resistance training improves glycemic control in older patients with type 2 diabetes. Diabetes Care 2002, 25:1729-1736. 10.2337/diacare.25.10.1729.
51. Honkola A., Forsen T., Eriksson J. Resistance training improves the metabolic profile in individuals with type 2 diabetes. Acta Diabetol 1997, 34:245-248. 10.1007/s005920050082.
52. Ibanez J., Izquierdo M., Arguelles I., Forga L., Larrion J.L., Garcia-Unciti M., et al. Twice-weekly progressive resistance training decreases abdominal fat and improves insulin sensitivity in older men with type 2 diabetes. Diabetes Care 2005, 28:662-667. 10.2337/diacare.28.3.662.
53. Ishii T., Yamakita T., Sato T., Tanaka S., Fujii S. Resistance training improves insulin sensitivity in NIDDM subjects without altering maximal oxygen uptake. Diabetes Care 1998, 21:1353-1355. 10.2337/diacare.21.8.1353.
54. Umpierre D., Ribeiro P.A., Kramer C.K., Leitao C.B., Zucatti A.T., Azevedo M.J., et al. Physical activity advice only or structured exercise training and association with HbA1C levels in type 2 diabetes: a systematic review and meta-analysis. JAMA 2011, 305:1790-1799. 10.1001/jama.2011.576.
55. Ballor D.L., Poehlman E.T. Exercise-training enhances fat-free mass preservation during diet-induced weight loss: a meta-analytical finding. Int J Obes Relat Metab Disord 1994, 18:35-40.
56. Sweeney M.E., Hill J.O., Heller P.A., Baney R., DiGirolamo M. Severe vs moderate energy restriction with and without exercise in the treatment of obesity: efficiency of weight loss. Am J Clin Nutr 1993, 57:127-134.
57. Gibson A.L., Holmes J.C., Desautels R.L., Edmonds L.B., Nuudi L. Ability of new octapolar bioimpedance spectroscopy analyzers to predict 4-component-model percentage body fat in Hispanic, black, and white adults. Am J Clin Nutr 2008, 87:332-338.
58. Chobanian A.V., Bakris G.L., Black H.R., Cushman W.C., Green L.A., Izzo J.L., et al. Seventh report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure. Hypertension 2003, 42:1206-1252. 10.1161/01.HYP.0000107251.49515.c2.
59. Perloff D., Grim C., Flack J., Frohlich E.D., Hill M., McDonald M., et al. Human blood pressure determination by sphygmomanometry. Circulation 1993, 88:2460-2470.
60. Harris E.H. Elevated liver function tests in type 2 diabetes. Clin Diabetes 2005, 23:115-119. 10.2337/diaclin.23.3.115.
61. de Oliveira E.P., Burini R.C. High plasma uric acid concentration: causes and consequences. Diabetol Metab Syndr 2012, 4:12. 10.1186/1758-5996-4-12.
62. Ebbeling C.B., Ward A., Puleo E.M., Widrick J., Rippe J.M. Development of a single-stage submaximal treadmill walking test. Med Sci Sports Exerc 1991, 23:966-973.
63. Bell D.R., Padua D.A., Clark M.A. Muscle strength and flexibility characteristics of people displaying excessive medial knee displacement. Arch Phys Med Rehabil 2008, 89:1323-1328. 10.1016/j.apmr.2007.11.048.
64. Courneya K.S., Jones L.W., Rhodes R.E., Blanchard C.M. Effects of different combinations of intensity categories on self-reported exercise. Res Q Exerc Sport 2004, 75:429-433. 10.1080/02701367.2004.10609176.
65. Godin G., Shephard R.J. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci 1985, 10:141-146.
66. Marshall A.L., Miller Y.D., Burton N.W., Brown W.J. Measuring total and domain-specific sitting: a study of reliability and validity. Med Sci Sports Exerc 2010, 42:1094-1102. 10.1249/MSS.0b013e3181c5ec18.
67. Collins C.E., Boggess M.M., Watson J.F., Guest M., Duncanson K., Pezdirc K., et al. Reproducibility and comparative validity of a food frequency questionnaire for Australian adults. Clin Nutr 2013, 10.1016/j.clnu.2013.09.015.
68. Marshall S., Watson J., Burrows T., Guest M., Collins C.E. The development and evaluation of the Australian child and adolescent recommended food score: a cross-sectional study. Nutr J 2012, 11:96. 10.1186/1475-2891-11-96.
69. Australian Bureau of Statistics National Nutrition Survey: nutrient intakes and physical measurements 1998, Commonwealth of Australia, Canberra.
70. Giles C.G., Ireland P.D. Dietary Questionnaire for Epidemiological Studies (version 2) 1996, [Melbourne].
71. Hodge A., Patterson A.J., Brown W.J., Ireland P., Giles G. The Anti Cancer Council of Victoria FFQ: relative validity of nutrient intakes compared with weighed food records in young to middle-aged women in a study of iron supplementation. Aust N Z J Public Health 2000, 24:576-583.
72. Bush K., Kivlahan D.R., McDonell M.B., Fihn S.D., Bradley K.A. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med 1998, 158:1789-1795.
73. Ware J., Kosinski M., Keller S.D. A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996, 34:220-233.
74. Australian Bureau of Statistics Socio-Economic Indexes for Areas (SEIFA) 2011: the index of relative socio-economic advantage and disadvantage 2013, Commonwealth of Australia, Canberra.
75. American Diabetes Association Diagnosis and classification of diabetes mellitus. Diabetes Care 2014, 37(Suppl. 1):S81-90. 10.2337/dc14-S081.
76. Alberti K.G., Zimmet P., Shaw J. Metabolic syndrome-a new world-wide definition. A consensus statement from the International Diabetes Federation. Diabet Med 2006, 23:469-480. 10.1111/j.1464-5491.2006.01858.x.
77. Fayers P., King M. The baseline characteristics did not differ significantly. Qual Life Res 2008, 17:1047-1048. 10.1007/s11136-008-9382-x.