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      The Happy Life Club™ study protocol: A cluster randomised controlled trial of a type 2 diabetes health coach intervention

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          Abstract

          Background

          The Happy Life Club™ is an intervention that utilises health coaches trained in behavioural change and motivational interviewing techniques to assist with the management of type 2 diabetes mellitus (T2DM) in primary care settings in China. Health coaches will support participants to improve modifiable risk factors and adhere to effective self-management treatments associated with T2DM.

          Methods/Design

          A cluster randomised controlled trial involving 22 Community Health Centres (CHCs) in Fengtai District of Beijing, China. CHCs will be randomised into a control or intervention group, facilitating recruitment of at least 1320 individual participants with T2DM into the study. Participants in the intervention group will receive a combination of both telephone and face-to-face health coaching over 18 months, in addition to usual care received by the control group. Health coaching will be performed by CHC doctors and nurses certified in coach-assisted chronic disease management. Outcomes will be assessed at baseline and again at 6, 12 and 18 months by means of a clinical health check and self-administered questionnaire. The primary outcome measure is HbA1c level. Secondary outcomes include metabolic, physiological and psychological variables.

          Discussion

          This cluster RCT has been developed to suit the Chinese health care system and will contribute to the evidence base for the management of patients with T2DM. With a strong focus on self-management and health coach support, the study has the potential to be adapted to other chronic diseases, as well as other regions of China.

          Trial Registration

          Current Controlled Trials ISRCTN01010526

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          Most cited references22

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          Is China facing an obesity epidemic and the consequences? The trends in obesity and chronic disease in China.

          Y. WANG, J. Mi, X-Y Shan … (2007)
          Over the past two decades, China has enjoyed impressive economic development, and her citizens have experienced many remarked changes in their lifestyle. These changes are often associated with an increase in obesity and chronic disease. In this meta-analysis, based on nationally representative data, we studied the current prevalence of obesity and the trends in obesity, mortality and morbidity in China. Between 1992 and 2002, the prevalence of overweight and obesity increased in all gender and age groups and in all geographic areas. Using the World Health Organization body mass index cut points, the combined prevalence of overweight and obesity increased from 14.6 to 21.8%. The Chinese obesity standard shows an increase from 20.0 to 29.9%. The annual increase rate was highest in men aged 18-44 years and women aged 45-59 years (approximately 1.6 and 1.0% points, respectively). In general, male subjects, urban residents, and high-income groups had a greater increase. With the increase in overweight and obesity, obesity-, and diet-related chronic diseases (e.g., hypertension, cardiovascular disease (CVD), and type 2 diabetes) also increased over the past decade and became a more important preventable cause of death. Hypertension increased from 14.4% in 1991 to 18.8% in 2002 in adults; in older adults aged 35-74 years, it increased from 19.7 to 28.6%. Between 1993 and 2003, the prevalence of CVD increased from 31.4 to 50.0%; diabetes increased from 1.9 to 5.6%. During 1990-2003, although total mortality rate (per 100 000) decreased, overall the mortality rate and contribution (as percentages) to total death of obesity-related chronic disease increased, in particular, in rural areas. Mortality rate (per 100 000) of CVD increased from 128 to 145 and its contribution to total death, 27 to 32%, in rural areas; the figures decreased slightly in urban areas. The mortality rate of 'nutrition, endocrinology and metabolism-related disease' (NEMD) increased in both rural and urban areas between 1990 and 2000, 8.0 to 10.6 and 4.9 to 5.3, respectively. The current prevalence of hypertension, dyslipidaemia, metabolic syndrome, and diabetes among Chinese adults is approximately 20, 20, 15, and 3%, respectively. The prevalence of overweight and obesity and obesity-related chronic diseases have increased in China in the past decade. Our findings provide useful information for the projection of future trends and the formulation of national strategies and programmes that can address the challenges of the growing obesity and chronic disease epidemic.
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            Chinese SF-36 Health Survey: translation, cultural adaptation, validation, and normalisation.

            L. Li, H Wang, Y. Shen (2003)
            To develop a self administered Chinese (mainland) version of the Short-Form Health Survey (SF-36) for use in health related quality of life measurements in China. A three stage protocol was followed including translation, tests of scaling construction and scoring assumptions, validation, and normalisation. 1000 households in 18 communities of Hangzhou. 1688 respondents recruited by multi-stage mixed sampling. The assumption of equal intervals was violated for the vitality and mental health scales. The recoded item values were used to calculate scale scores. The clustering and ordering of item means was the same as that of the source and other two Chinese versions. The items in each scale had similar standard deviations except those in the physical functioning, boduily pain, social functioning scales. The item hypothesised scale correlations were identical for all except the social functioning and vitality scales. Convergent validity and discriminant validity were satisfactory for all except the social functioning scale. Cronbach's alpha coefficients ranged from 0.72 to 0.88 except 0.39 for the social functioning scale and 0.66 for the vitality scale. Two weeks test-retest reliability coefficients ranged from 0.66 to 0.94. Factor analysis identified two principal components explaining 56.3% of the total variance. The Chinese SF-36 could distinguish known groups. This study suggested that the Chinese (mainland) version of the SF-36 functioned in the general population of Hangzhou, China quite similarly to the original American population tested. Caution is recommended in the interpretation of the social functioning and vitality scales pending further studies.
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              Ten things that motivational interviewing is not.

              Joan W. Miller, Stephen Rollnick (2009)
              In the 26 years since it was first introduced in this journal, motivational interviewing (MI) has become confused with various other ideas and approaches, owing in part to its rapid international diffusion. Based on confusions that have arisen in publications and presentations regarding MI, the authors compiled a list of 10 concepts and procedures with which MI should not be addled. This article discusses 10 things that MI is not: (1) the transtheoretical model of change; (2) a way of tricking people into doing what you want them to do; (3) a technique; (4) decisional balance; (5) assessment feedback; (6) cognitive-behavior therapy; (7) client-centered therapy; (8) easy to learn; (9) practice as usual; and (10) a panacea. Clarity about what does (and does not) constitute MI promotes quality assurance in scientific research, clinical practice, and training.
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                Author and article information

                Journal
                Journal ID (nlm-ta): BMC Public Health
                Title: BMC Public Health
                Publisher: BioMed Central
                ISSN (Electronic): 1471-2458
                Publication date Collection: 2011
                Publication date (Electronic): 9 February 2011
                Volume: 11
                Page: 90
                Affiliations
                [1 ]Primary Care Research Unit, School of Primary Health Care, Monash University, Building 1, 270 Ferntree Gully Road, Notting Hill, Victoria, 3168 Australia
                [2 ]Centre of Disease Control and Prevention, Fengtai District Beijing, 3 Xi An Street, Fengtai District, Beijing, 100071 China
                [3 ]Department of Health Policy and Management, School of Public Health, Peking University Health Science Centre, 38 Xueyuanlu Street, Haidian District, Beijing, 100191 China
                Article
                Publisher ID: 1471-2458-11-90
                DOI: 10.1186/1471-2458-11-90
                PMC ID: 3041664
                PubMed ID: 21303564
                SO-VID: b036a306-5737-4490-8f95-e47407b9f1e1
                Copyright © Copyright ©2011 Browning et al; licensee BioMed Central Ltd.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 15 November 2010
                Date accepted : 9 February 2011
                Categories
                Subject: Study Protocol

                ScienceOpen disciplines: Public health
                Data availability:
                ScienceOpen disciplines: Public health

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