TITLE

The ProActive trial protocol -- a randomised controlled trial of the efficacy of a family-based, domiciliary intervention programme to increase physical activity among individuals at high risk of diabetes [ISRCTN61323766]

AUTHOR(S)

Williams, Kate; Prevost, A. Toby; Griffin, Simon; Hardeman, Wendy; Hollingworth, William; Spiegelhalter, David; Sutton, Stephen; Ekelund, Ulf; Wareham, Nicholas; Kinmonth, Ann Louise

PUB. DATE

January 2004

SOURCE

BMC Public Health;2004, Vol. 4, p1

SOURCE TYPE

Academic Journal

DOC. TYPE

Article

ABSTRACT

Background: Increasing prevalence of obesity and disorders associated with sedentary living constitute a major global public health problem. While previous evaluations of interventions to increase physical activity have involved communities or individuals with established disease, less attention has been given to interventions for individuals at risk of disease. Methods/design: ProActive aims to evaluate the efficacy of a theoretical, evidence- and family-based intervention programme to increase physical activity in a sedentary population, defined as being at-risk through having a parental family history of diabetes. Primary care diabetes or family history registers were used to recruit 365 individuals aged 30-50 years, screened for activity level. Participants were assigned by central randomisation to three intervention programmes: brief written advice (comparison group), or a psychologically based behavioural change programme, delivered either by telephone (distance group) or face-to-face in the family home over one year. The protocol-driven intervention programme is delivered by trained facilitators, and aims to support increases in physical activity through the introduction and facilitation of a range of self-regulatory skills (e.g. goal setting). The primary outcome is daytime energy expenditure and its ratio to resting energy expenditure, measured at baseline and one year using individually calibrated heart rate monitoring. Secondary measures include self-report of individual and family activity, psychological mediators of behaviour change, physiological and biochemical correlates, acceptability, and costs, measured at baseline, six months and one year. The primary intention to treat analysis will compare groups at one-year post randomisation. Estimation of the impact on diabetes incidence will be modelled using data from a parallel ten-year cohort study using similar measures. Discussion: ProActive is the first efficacy trial of an intervention programme to promote physical activity in a defined high-risk group accessible through primary care. The intervention programme is based on psychological theory and evidence; it introduces and facilitates the use of self-regulatory skills to support behaviour change and maintenance. The trial addresses a range of methodological weaknesses in the field by careful specification and quality assurance of the intervention programme, precise characterisation of participants, year-long follow-up and objective measurement of physical activity. Due to report in 2005, ProActive will provide estimates of the extent to which this approach could assist at-risk groups who could benefit from changes in behaviours affecting health, and inform future pragmatic trials.

ACCESSION #

29361740

 

Related Articles

• Physical Inactivity and Mortality Risk. Kokkinos, Peter; Sheriff, Helen; Kheirbek, Raya // Cardiology Research & Practice;2011, p1 

  In recent years a plethora of epidemiologic evidence accumulated supports a strong, independent and inverse, association between physical activity and the fitness status of an individual and mortality in apparently healthy individuals and diseased populations. These health benefits are realized...

• Epidemiological studies of physical activity and diabetes risk, and implications for diabetes prevention. Wareham, Nicholas J. // Applied Physiology, Nutrition & Metabolism;Aug2007, Vol. 32 Issue 4, p778 

  The evidence linking physical inactivity to the future risk of type 2 diabetes is strong, and modification of behaviour is a critical and effective element of strategies aimed at the prevention of this increasingly prevalent disorder. Two key unresolved epidemiologic issues relate to the type of...

• Cardiovascular risk profile: Cross-sectional analysis of motivational determinants, physical fitness and physical activity. Sassen, Barbara; Kok, Gerjo; Schaalma, Herman; Kiers, Henri; Vanhees, Luc // BMC Public Health;2010, Vol. 10, p592 

  Background: Cardiovascular risk factors are associated with physical fitness and, to a lesser extent, physical activity. Lifestyle interventions directed at enhancing physical fitness in order to decrease the risk of cardiovascular diseases should be extended. To enable the development of...

• High prevalence of undiagnosed diabetes mellitus in Southern Germany: Target populations for efficient screening. The KORA survey 2000 W. Rathmann et al.: Undiagnosed diabetes in Germany: KORA Survey 2000. Rathmann, W.; Haastert, B.; Icks, A.; Löwel, H.; Meisinger, C.; Holle, R.; Giani, G. // Diabetologia;Feb2003, Vol. 46 Issue 2, p182 

  Aims/hypothesis. To estimate the prevalence of undiagnosed diabetes mellitus, impaired glucose tolerance (IGT) and impaired fasting glucose (IFG), and their relations with cardiovascular risk factors in the general population aged 55 to 74 years in Southern Germany. Methods. Oral glucose...

• Adult Participation in Recommended Levels of Physical Activity - United States, 2001 and 2003.  // JAMA: Journal of the American Medical Association;1/4/2006, Vol. 295 Issue 1, p27 

  This article reports on a study of differences in adult participation in recommended levels of physical activity in the United States from 2001 to 2003. Physical activity is associated with a range of health benefits, and its absence can have harmful effects on health and well being. A lack of...

• A Randomized Controlled Trial of Prenatal Physical Activity to Prevent Gestational Diabetes: Design and Methods. Chasan-Taber, Lisa; Marcus, Bess H.; Stanek III, Edward; Ciccolo, Joseph T.; Marquez, David X.; Solomon, Caren G.; Markenson, Glenn // Journal of Women's Health (15409996);Jun2009, Vol. 18 Issue 6, p851 

  Background: Women diagnosed with gestational diabetes mellitus (GDM) are at substantially increased risk of developing type 2 diabetes and obesity, currently at epidemic rates in the United States. GDM, therefore, identifies a population of women at high risk of developing type 2 diabetes and...

• Excess Weight and Obesity. Serrano JR, Carlos Vicente; Cardoso, Paulo O. // World Medical Journal;Feb2014, Vol. 60 Issue 1, p34 

  The article discusses the problem of excess weight and obesity. The topics discussed include the risks associated with excess weight and obesity including the risk of coronary heart disease and diabetes, the benefits of regular physical exercise in weight management, and the public health...

• Diabetes: Have We Got It All Wrong? CORKEY, BARBARA E. // Diabetes Care;Dec2012, Vol. 35 Issue 12, p2432 

  The article informs that gradual increase in obesity and diabetes, and health risks associated with them make it urgent to identify causative agents. It has been informed that the cause of the epidemic increase in diabetes and obesity is environmental changes rather than genetic as these...

• Managing chronic oedema in the morbidly obese patient. Todd, Marie // British Journal of Nursing;10/8/2009, Vol. 18 Issue 18, p1120 

  The obesity epidemic has become one of the major challenges for health and social policy makers around the world. The increase in obesity is commensurate with the rise in associated complications, including type 2 diabetes, cardiovascular disease and some types of cancer (breast, colon,...

Read the Article