Evidence map›Paper›PMID 26944692›Full record

Trial reportBMJ open2016

Management of type 2 diabetes in China: the Happy Life Club, a pragmatic cluster randomised controlled trial using health coaches.

Colette Browning, Anna Chapman, Hui Yang, Shuo Liu, Tuohong Zhang, Joanne C Enticott, Shane A Thomas

Open access · goldAbstract readMulticenter StudyPragmatic Clinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 11 pooled it
4.5field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 11 syntheses or guidelines pooled it, 57 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 2 countries.

Colette BrowningRDNS 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.
Anna ChapmanRDNS Institute, Melbourne, Victoria, Australia Faculty of Medicine Nursing and Health Sciences, School of Primary Health Care, Monash University, Melbourne, Victoria, Australia.
Hui YangFaculty 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.
Shuo LiuBeijing Office for Cancer Prevention and Control, Peking University Cancer Hospital and Institute, Beijing, China.
Tuohong ZhangSchool of Public Health, Peking University Health Science Centre, Beijing, China.
Joanne C EnticottRDNS 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.
Shane A ThomasFaculty 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.
Monash University · AUPeking University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo 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.

designPragmatic cluster randomised controlled trial (RCT).

settingCommunity Health Stations (CHSs) in Fengtai district, Beijing, China.

participantsOf the 41 randomised CHSs (21 intervention and 20 control), 21 intervention CHSs (372 participants) and 18 control CHSs (296 participants) started participation.

interventionIntervention 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.

resultsAt 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.

conclusionsIn 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.

Indexed as

Disease ManagementAgedBlood GlucoseBlood PressureChinaCholesterol, LDLCommunicationCounselingDiabetes Mellitus, Type 2FemaleGlycated HemoglobinHumansMaleMiddle AgedMultivariate AnalysisQuality of LifeBlood GlucoseCholesterol, LDLGlycated HemoglobinPRIMARY CARE

Identifiers

PMID26944692
PMCPMC4785304
OpenAlexW2292805247

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.