title: The Happy Life Club™ study protocol: a cluster randomised controlled trial of a type 2 diabetes health coach intervention.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN01010526.
authors.affiliation: Primary Care Research Unit, School of Primary Health Care, Monash University, Building 1, 270 Ferntree Gully Road, Notting Hill, Victoria 3168, Australia.
authors.forename: Colette
authors.initials: C
authors.lastname: Browning
authors.forename: Anna
authors.initials: A
authors.lastname: Chapman
authors.forename: Sean
authors.initials: S
authors.lastname: Cowlishaw
authors.forename: Zhixin
authors.initials: Z
authors.lastname: Li
authors.forename: Shane A
authors.initials: SA
authors.lastname: Thomas
authors.forename: Hui
authors.initials: H
authors.lastname: Yang
authors.forename: Tuohong
authors.initials: T
authors.lastname: Zhang
mesh_terms: D002681:China; D016000:Cluster Analysis; D003151:Community Health Centers; D003924:Diabetes Mellitus, Type 2 / Q000628:therapy*; D037001:Directive Counseling; D019468:Disease Management; D005260:Female; D006801:Humans; D008297:Male; D009042:Motivation; D011320:Primary Health Care; D015397:Program Evaluation; D012107:Research Design; D040242:Risk Reduction Behavior; D012944:Social Support; D011795:Surveys and Questionnaires