title: Management of type 2 diabetes in China: the Happy Life Club, a pragmatic cluster randomised controlled trial using health coaches.
abstract: OBJECTIVE
  To assess the effectiveness of a coach-led motivational interviewing (MI) intervention in improving glycaemic control, as well as clinical, psychosocial and self-care outcomes of individuals with type 2 diabetes mellitus (T2DM) compared with usual care.
  
  
  METHODS
  Pragmatic cluster randomised controlled trial (RCT).
  
  
  METHODS
  Community Health Stations (CHSs) in Fengtai district, Beijing, China.
  
  
  METHODS
  Of the 41 randomised CHSs (21 intervention and 20 control), 21 intervention CHSs (372 participants) and 18 control CHSs (296 participants) started participation.
  
  
  METHODS
  Intervention participants received telephone and face-to-face MI health coaching in addition to usual care from their CHS. Control participants received usual care only. Medical fees were waived for both groups.
  
  
  METHODS
  Outcomes were assessed at baseline, 6 and 12 months. Primary outcome measure was glycated haemoglobin (HbA1c). Secondary outcomes included a suite of anthropometric, blood pressure (BP), fasting blood, psychosocial and self-care measures.
  
  
  RESULTS
  At 12 months, no differential treatment effect was found for HbA1c (adjusted difference 0.02, 95% CI -0.40 to 0.44, p=0.929), with both treatment and control groups showing significant improvements. However, two secondary outcomes: psychological distress (adjusted difference -2.38, 95% CI -4.64 to -0.12, p=0.039) and systolic BP (adjusted difference -3.57, 95% CI -6.08 to -1.05, p=0.005) were robust outcomes consistent with significant differential treatment effects, as supported in sensitivity analyses. Interestingly, in addition to HbA1c, both groups displayed significant improvements in triglycerides, LDL cholesterol and HDL cholesterol.
  
  
  CONCLUSIONS
  In line with the current Chinese primary healthcare reform, this study is the first large-scale cluster RCT to be implemented within real-world CHSs in China, specifically addressing T2DM. Although a differential treatment effect was not observed for HbA1c, numerous outcomes (including HbA1c) improved in both groups, supporting the establishment of regular, free clinical health checks for people with T2DM in China.
  
  
  BACKGROUND
  ISRCTN01010526; Pre-results.
authors.affiliation: RDNS Institute, Melbourne, Victoria, Australia Faculty of Medicine Nursing and Health Sciences, School of Primary Health Care, Monash University, Melbourne, Victoria, Australia International Institute for Primary Health Care Research, Shenzhen, China.
authors.forename: Colette
authors.initials: C
authors.lastname: Browning
authors.affiliation: RDNS Institute, Melbourne, Victoria, Australia Faculty of Medicine Nursing and Health Sciences, School of Primary Health Care, Monash University, Melbourne, Victoria, Australia.
authors.forename: Anna
authors.initials: A
authors.lastname: Chapman
authors.affiliation: Faculty of Medicine Nursing and Health Sciences, School of Primary Health Care, Monash University, Melbourne, Victoria, Australia International Institute for Primary Health Care Research, Shenzhen, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Yang
authors.affiliation: Beijing Office for Cancer Prevention and Control, Peking University Cancer Hospital and Institute, Beijing, China.
authors.forename: Shuo
authors.initials: S
authors.lastname: Liu
authors.affiliation: School of Public Health, Peking University Health Science Centre, Beijing, China.
authors.forename: Tuohong
authors.initials: T
authors.lastname: Zhang
authors.affiliation: RDNS Institute, Melbourne, Victoria, Australia Faculty of Medicine Nursing and Health Sciences, School of Primary Health Care, Monash University, Melbourne, Victoria, Australia School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia.
authors.forename: Joanne C
authors.initials: JC
authors.lastname: Enticott
authors.affiliation: Faculty of Medicine Nursing and Health Sciences, School of Primary Health Care, Monash University, Melbourne, Victoria, Australia International Institute for Primary Health Care Research, Shenzhen, China.
authors.forename: Shane A
authors.initials: SA
authors.lastname: Thomas
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D001794:Blood Pressure; D002681:China; D008078:Cholesterol, LDL; D003142:Communication; D003376:Counseling / Q000379:methods*; D003924:Diabetes Mellitus, Type 2 / Q000628:therapy*; D019468:Disease Management; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011788:Quality of Life; D012044:Regression Analysis; D012648:Self Care; D013689:Telephone; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D008078:Cholesterol, LDL; D006442:Glycated Hemoglobin
keywords: PRIMARY CARE