PMID- 21303564 OWN - NLM STAT- MEDLINE DCOM- 20110630 LR - 20240322 IS - 1471-2458 (Electronic) IS - 1471-2458 (Linking) VI - 11 DP - 2011 Feb 9 TI - The Happy Life Club study protocol: a cluster randomised controlled trial of a type 2 diabetes health coach intervention. PG - 90 LID - 10.1186/1471-2458-11-90 [doi] AB - 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. FAU - Browning, Colette AU - Browning C AD - Primary Care Research Unit, School of Primary Health Care, Monash University, Building 1, 270 Ferntree Gully Road, Notting Hill, Victoria 3168, Australia. FAU - Chapman, Anna AU - Chapman A FAU - Cowlishaw, Sean AU - Cowlishaw S FAU - Li, Zhixin AU - Li Z FAU - Thomas, Shane A AU - Thomas SA FAU - Yang, Hui AU - Yang H FAU - Zhang, Tuohong AU - Zhang T LA - eng SI - ISRCTN/ISRCTN01010526 PT - Journal Article PT - Randomized Controlled Trial DEP - 20110209 PL - England TA - BMC Public Health JT - BMC public health JID - 100968562 SB - IM MH - China MH - Cluster Analysis MH - Community Health Centers MH - Diabetes Mellitus, Type 2/*therapy MH - *Directive Counseling MH - *Disease Management MH - Female MH - Humans MH - Male MH - Motivation MH - Primary Health Care MH - Program Evaluation MH - Research Design MH - Risk Reduction Behavior MH - *Social Support MH - Surveys and Questionnaires PMC - PMC3041664 EDAT- 2011/02/10 06:00 MHDA- 2011/07/01 06:00 PMCR- 2011/02/09 CRDT- 2011/02/10 06:00 PHST- 2010/11/15 00:00 [received] PHST- 2011/02/09 00:00 [accepted] PHST- 2011/02/10 06:00 [entrez] PHST- 2011/02/10 06:00 [pubmed] PHST- 2011/07/01 06:00 [medline] PHST- 2011/02/09 00:00 [pmc-release] AID - 1471-2458-11-90 [pii] AID - 10.1186/1471-2458-11-90 [doi] PST - epublish SO - BMC Public Health. 2011 Feb 9;11:90. doi: 10.1186/1471-2458-11-90.