PMID- 26944692
OWN - NLM
STAT- MEDLINE
DCOM- 20161213
LR  - 20240327
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 6
IP  - 3
DP  - 2016 Mar 4
TI  - Management of type 2 diabetes in China: the Happy Life Club, a pragmatic cluster 
      randomised controlled trial using health coaches.
PG  - e009319
LID - 10.1136/bmjopen-2015-009319 [doi]
LID - e009319
AB  - 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. DESIGN: Pragmatic cluster randomised controlled 
      trial (RCT). SETTING: Community Health Stations (CHSs) in Fengtai district, 
      Beijing, China. PARTICIPANTS: Of the 41 randomised CHSs (21 intervention and 20 
      control), 21 intervention CHSs (372 participants) and 18 control CHSs (296 
      participants) started participation. INTERVENTION: 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. OUTCOME MEASURES: 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. TRIAL REGISTRATION NUMBER: ISRCTN01010526; 
      Pre-results.
CI  - Published by the BMJ Publishing Group Limited. For permission to use (where not 
      already granted under a licence) please go to 
      http://www.bmj.com/company/products-services/rights-and-licensing/
FAU - Browning, Colette
AU  - Browning C
AD  - 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.
FAU - Chapman, Anna
AU  - Chapman A
AD  - RDNS Institute, Melbourne, Victoria, Australia Faculty of Medicine Nursing and 
      Health Sciences, School of Primary Health Care, Monash University, Melbourne, 
      Victoria, Australia.
FAU - Yang, Hui
AU  - Yang H
AD  - 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.
FAU - Liu, Shuo
AU  - Liu S
AD  - Beijing Office for Cancer Prevention and Control, Peking University Cancer 
      Hospital and Institute, Beijing, China.
FAU - Zhang, Tuohong
AU  - Zhang T
AD  - School of Public Health, Peking University Health Science Centre, Beijing, China.
FAU - Enticott, Joanne C
AU  - Enticott JC
AD  - 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.
FAU - Thomas, Shane A
AU  - Thomas SA
AD  - 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.
LA  - eng
SI  - ISRCTN/ISRCTN01010526
PT  - Journal Article
PT  - Multicenter Study
PT  - Pragmatic Clinical Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20160304
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
RN  - 0 (Blood Glucose)
RN  - 0 (Cholesterol, LDL)
RN  - 0 (Glycated Hemoglobin A)
SB  - IM
MH  - Aged
MH  - Blood Glucose/analysis
MH  - Blood Pressure
MH  - China
MH  - Cholesterol, LDL
MH  - Communication
MH  - Counseling/*methods
MH  - Diabetes Mellitus, Type 2/*therapy
MH  - *Disease Management
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Multivariate Analysis
MH  - Quality of Life
MH  - Regression Analysis
MH  - Self Care
MH  - Telephone
MH  - Treatment Outcome
PMC - PMC4785304
OTO - NOTNLM
OT  - PRIMARY CARE
EDAT- 2016/03/06 06:00
MHDA- 2016/12/15 06:00
PMCR- 2016/03/03
CRDT- 2016/03/06 06:00
PHST- 2016/03/06 06:00 [entrez]
PHST- 2016/03/06 06:00 [pubmed]
PHST- 2016/12/15 06:00 [medline]
PHST- 2016/03/03 00:00 [pmc-release]
AID - bmjopen-2015-009319 [pii]
AID - 10.1136/bmjopen-2015-009319 [doi]
PST - epublish
SO  - BMJ Open. 2016 Mar 4;6(3):e009319. doi: 10.1136/bmjopen-2015-009319.