A pragmatic randomised controlled trial in primary care of the Camden Weight Loss (CAMWEL) programme

Kiran Nanchahal, Tom Power, Elizabeth Holdsworth, Michelle Hession, Annik Sorhaindo, Ulla Griffiths, Joy Townsend, Nicki Thorogood, David Haslam, Anthony Kessel, Shah Ebrahim, Mike Kenward, Andrew Haines, Kiran Nanchahal, Tom Power, Elizabeth Holdsworth, Michelle Hession, Annik Sorhaindo, Ulla Griffiths, Joy Townsend, Nicki Thorogood, David Haslam, Anthony Kessel, Shah Ebrahim, Mike Kenward, Andrew Haines

Abstract

Objectives: To evaluate effectiveness of a structured one-to-one behaviour change programme on weight loss in obese and overweight individuals.

Design: Randomised controlled trial.

Setting: 23 general practices in Camden, London.

Participants: 381 adults with body mass index ≥25 kg/m(2) randomly assigned to intervention (n=191) or control (n=190) group.

Interventions: A structured one-to-one programme, delivered over 14 visits during 12 months by trained advisors in three primary care centres compared with usual care in general practice.

Outcome measures: Changes in weight, per cent body fat, waist circumference, blood pressure and heart rate between baseline and 12 months.

Results: 217/381 (57.0%) participants were assessed at 12 months: missing values were imputed. The difference in mean weight change between the intervention and control groups was not statistically significant (0.70 kg (0.67 to 2.17, p=0.35)), although a higher proportion of the intervention group (32.7%) than the control group (20.4%) lost 5% or more of their baseline weight (OR: 1.80 (1.02 to 3.18, p=0.04)). The intervention group achieved a lower mean heart rate (mean difference 3.68 beats per minute (0.31 to 7.04, p=0.03)) than the control group. Participants in the intervention group reported higher satisfaction and more positive experiences of their care compared with the control group.

Conclusions: Although there is no significant difference in mean weight loss between the intervention and control groups, trained non-specialist advisors can deliver a structured programme and achieve clinically beneficial weight loss in some patients in primary care. The intervention group also reported a higher level of satisfaction with the support received. Primary care interventions are unlikely to be sufficient to tackle the obesity epidemic and effective population-wide measures are also necessary.

Clinical trial registration number: Trial registrationClincaltrials.gov NCT00891943.

Conflict of interest statement

Competing interests: All authors have completed the Unified Competing Interest form at http://www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare that KN, TP, EH, MH, AS, UG and JLT had salary support from NHS Camden for the submitted work. AK was Director of Public Health at Camden Primary Care Trust between 2004 and 2009. The views expressed here are personal, and no financial support was received for the other authors' involvement in the CAMWEL Trial. No authors have had a relationship with companies that might have an interest in the submitted work in the previous 3 years nor do their spouses, partners or children have financial relationships that may be relevant to the submitted work. DH is on the scientific advisory board for LighterLife and no other authors have non-financial interests that may be relevant to the submitted work.

Figures

Figure 1
Figure 1
CAMWEL intervention framework.
Figure 2
Figure 2
Flow of participants through the trial.

References

    1. Whitlock G, Lewington S, Sherliker P, et al. ; Prospective Studies Collaboration Body-mass index and cause-specific mortality in 900,000 adults: collaborative analyses of 57 prospective studies. Lancet 2009;373:1083–96
    1. Global Health Risks Mortality and Burden of Diseases Attributable to Selected Major Risks. Geneva: World Health Orgainisation, 2009
    1. Finucane MM, Stevens GA, Cowan MJ, et al. ; Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Body Mass Index) National, regional, and global trends in body-mass index since 1980: systematic analysis of health examination surveys and epidemiological studies with 960 country-years and 9.1 million participants. Lancet 2011;377:557–67
    1. Whitlock G, Lewington S, Mhurchu CN. Coronary heart disease and body mass index: a systematic review of the evidence from larger prospective cohort studies. Semin Vasc Med 2002;2:369–81
    1. Haslam DW, James WP. Obesity. Lancet 2005;366:1197–209
    1. Foresight Tackling Obesities: Future Choices. London: Government Office for Science, 2007
    1. The NHS Information Centre, lifestyles Statistics Statistics On Obesity, Physical Activity and Diet. England: 2012. (accessed Mar 2012).
    1. Perri MG, Limacher MC, Durning PE, et al. Extended-care programs for weight management in rural communities: the treatment of obesity in underserved rural settings (TOURS) randomized trial. Arch Intern Med 2008;168:2347–54
    1. Perri MG, Sears SF, Jr, Clark JE. Strategies for improving maintenance of weight loss. Toward a continuous care model of obesity management. Diabetes Care 1993;16:200–9
    1. Kinmonth AL, Wareham NJ, Hardeman W, et al. Efficacy of a theory-based behavioural intervention to increase physical activity in an at-risk group in primary care (ProActive UK): a randomised trial. Lancet 2008;371:41–8
    1. Wing RR, Phelan S. Long-term weight loss maintenance. Am J Clin Nutr 2005;82(Suppl 1):222S–5
    1. Aucott L, Poobalan A, Smith WC, et al. Weight loss in obese diabetic and non-diabetic individuals and long-term diabetes outcomes–a systematic review. Diabetes Obes Metab 2004;6:85–94
    1. Poobalan A, Aucott L, Smith WC, Avenell A, et al. Effects of weight loss in overweight/obese individuals and long-term lipid outcomes–a systematic review. Obes Rev 2004;5:43–50
    1. Avenell A, Broom J, Brown TJ, et al. Systematic review of the long-term effects and economic consequences of treatments for obesity and implications for health improvement. Health Technol Assess 2004;8:1–182
    1. Norris SL, Zhang X, Avenell A, et al. Long-term effectiveness of weight-loss interventions in adults with pre-diabetes: a review. Am J Prev Med 2005;28:126–39
    1. Norris SL, Zhang X, Avenell A, et al. Long-term effectiveness of lifestyle and behavioral weight loss interventions in adults with type 2 diabetes: a meta-analysis. Am J Med 2004;117:762–74
    1. Potter MB, Vu JD, Croughan-Minhane M. Weight management: what patients want from their primary care physicians. J Fam Pract 2001;50:513–18
    1. Nanchahal K, Townsend J, Letley L, et al. Weight-management interventions in primary care: a pilot randomised controlled trial. Br J Gen Pract 2009;59:e157–66
    1. Davies MJ, Heller S, Skinner TC, et al. ; Diabetes Education and Self Management for Ongoing and Newly Diagnosed Collaborative Effectiveness of the diabetes education and self management for ongoing and newly diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: cluster randomised controlled trial. BMJ 2008;336:491–5
    1. Trueman P, Haynes SM, Felicity Lyons G, et al. Long-term cost-effectiveness of weight management in primary care. Int J Clin Pract 2010;64:775–83
    1. Wardle J, Johnson F. Weight and dieting: examining levels of weight concern in British adults. Int J Obes Relat Metab Disord 2002;26:1144–9
    1. Campbell M, Fitzpatrick R, Haines A, et al. Framework for design and evaluation of complex interventions to improve health. BMJ 2000;321:694–6
    1. Jones LR, Wadden RA. State of the science: behavioural treatment of obesity. Asia Pac J Clin Nutr 2006;15(Suppl 1):30–9
    1. Bandura A. Health promotion by social cognitive means. Health Educ Behav 2004;31:143–64
    1. Locke EA, Latham GP. Building a practically useful theory of goal setting and task motivation: a 35-year odyssey. Am Psychol 2002;57:705–17
    1. Alemi F, Neuhauser D, Ardito S, et al. Continuous self-improvement: systems thinking in a personal context. Jt Comm J Qual Improv 2000;26:74–86
    1. NICE Clinical Guidance 43 Obesity: Quick Reference Guide 2 for the NHS. London: National Institute for Health and Clinical Excellence, 2006
    1. Koenigsberg MR, Bartlett D, Cramer JS. Facilitating treatment adherence with lifestyle changes in diabetes. Am Fam Physician 2004;69:309–16
    1. Abraham C, Michie S. A taxonomy of behavior change techniques used in interventions. Health Psychol 2008;27:379–87
    1. Miller WR, Rose GS. Toward a theory of motivational interviewing. Am Psychol 2009;64:527–37
    1. Foreyt JP, Poston WS. What is the role of cognitive-behavior therapy in patient management? Obes Res 1998;6(Suppl 1):18S–22
    1. Managing Obesity in Primary Care CD-ROM. National obesity Forum, 2004.
    1. Kellow J, Costain L, Walton R. The Calorie, Carb and Fat Bible. Peterborough: weight loss Resources, 2009
    1. Byoni Ltd Perfect Diet Tracker Software.
    1. Michie S, Rumsey N, Fussell A, et al. Improving Health: Changing Behaviour NHS Health Trainer Handbook. London: Department of Health, 2008
    1. British Heart Foundation So You Want to Lose Weight. For Good. London: British Heart Foundation, 2005
    1. NHS Camden Annual Report & Accounts 2009/10. Camden Primary Care Trust, 2010.
    1. Forward Planning Service London Borough of Camden Camden Profile 2010. London Borough of camden Forward Planning service.
    1. Patrick DL, Bushnell DM, Rothman M. Performance of two self-report measures for evaluating obesity and weight loss. Obes Res 2004;12:48–57
    1. Olssøn I, Mykletun A, Dahl AA. The Hospital Anxiety and Depression Rating Scale: a cross-sectional study of psychometrics and case finding abilities in general practice. BMC Psychiatry 2005;5:46.
    1. Rosenberg M. Society and the Adolescent Self Image. Princeton, NJ: Princeton University Press, 1965
    1. Broadhead WE, Gehlbach SH, de Gruy FV, et al. The Duke-UNC Functional Social Support Questionnaire: measurement of social support in family medicine patients. Med Care 1988;26:709–23
    1. Karlsson J, Persson LO, Sjöström L, et al. Psychometric properties and factor structure of the three-factor eating questionnaire (TFEQ) in obese men and women. Results from the Swedish obese subjects (SOS) study. Int J Obes Relat Metab Disord 2000;24:1715–25
    1. Besson H, Brage S, Jakes RW, et al. Estimating physical activity energy expenditure, sedentary time, and physical activity intensity by self-report in adults. Am J Clin Nutr 2010;91:106–14
    1. Department for Communities and Local Government The English Indices of Deprivation 2010. London: 2010.
    1. Glasgow RE, Wagner EH, Schaefer J, et al. Development and validation of the patient assessment of chronic illness care (PACIC). Med Care 2005;43:436–44
    1. Schmittdiel J, Mosen DM, Glasgow RE, et al. Patient Assessment of Chronic Illness Care (PACIC) and improved patient-centered outcomes for chronic conditions. J Gen Intern Med 2008;23:77–80
    1. Scott NW, McPherson GC, Ramsay CR, et al. The method of minimization for allocation to clinical trials: a review. Control Clin Trials 2002;23:662–74
    1. Douketis JD, Macie C, Thabane L, et al. Systematic review of long-term weight loss studies in obese adults: clinical significance and applicability to clinical practice. Int J Obes (Lond) 2005;29:1153–67
    1. Carpenter JR, Kenward MG. Missing Data in Clinical Trials—A Practical Guide. National Health Service Coordinating Centre for Research Methodology. Birmingham: 2008.
    1. Rubin DB. Multiple Imputation for Nonresponse in Surveys. New York: Wiley, 1987
    1. Kenward MG, Carpenter J. Multiple imputation: current perspectives. Stat Methods Med Res 2007;16:199–218
    1. Royston P. Multiple imputation of missing values. STATA Journal 2004;4:227–41
    1. Nanchahal K, Hession M, Power T, et al. Challenges in recruitment to clinical trials and lessons learned from a randomized controlled trial of a weight management intervention in general practice. Obes Rev 2010;11(Suppl S1):P214
    1. McConnon A, Kirk SF, Cockroft JE, et al. The Internet for weight control in an obese sample: results of a randomised controlled trial. BMC Health Serv Res 2007;7:206.
    1. Counterweight Project Team Evaluation of the Counterweight Programme for obesity management in primary care: a starting point for continuous improvement. Br J Gen Pract 2008;58:548–54
    1. Jebb SA, Ahern AL, Olson AD, et al. Primary care referral to a commercial provider for weight loss treatment versus standard care: a randomised controlled trial. Lancet 2011;378:1485–92
    1. Jolly K, Lewis A, Beach J, et al. Comparison of range of commercial or primary care led weight reduction programmes with minimal intervention control for weight loss in obesity: Lighten Up randomised controlled trial. BMJ 2011;343:d6500.
    1. Inelmen EM, Toffanello ED, Enzi G, et al. Predictors of drop-out in overweight and obese outpatients. Int J Obes (Lond) 2005;29:122–8
    1. Thomas E, Croft PR, Paterson SM, et al. What influences participants' treatment preference and can it influence outcome? Results from a primary care based randomised trial for shoulder pain. Br J Gen Pract 2004;54:93–6
    1. McCambridge J, Kypri K. Can simply answering research questions change behaviour? Systematic review and meta analyses of brief alcohol intervention trials. PLoS One 2011;6:e23748.
    1. Moore H, Summerbell CD, Greenwood DC, et al. Improving management of obesity in primary care: cluster randomised trial. BMJ 2003;327:1085.
    1. Ahern AL, Olson AD, Aston LM, et al. Weight Watchers on prescription: an observational study of weight change among adults referred to Weight Watchers by the NHS. BMC Public Health 2011;11:434.
    1. Woodcock J, Edwards P, Tonne C, et al. Public health benefits of strategies to reduce greenhouse-gas emissions: urban land transport. Lancet 2009;374:1930–43

Source: PubMed

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