Management of type 2 diabetes in China: the Happy Life Club, a pragmatic cluster randomised controlled trial using health coaches
Open accessAbstract
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.
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Seven RCTs reported non-significant improvements in self-efficacy.
“Seven RCTs reported non-significant improvements in self-efficacy”
From Helping patients help themselves: A systematic review of self-management support strategies in primary health care practice (2019) · cites this paper as [54]
The Results (page unavailable) report a significant worsening in diabetes self-efficacy among control participants, not a non-significant improvement. This paper reports one cluster RCT, not findings from seven RCTs. (LLM, conf=0.78)
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Experimental — accuracy not yet measuredPhysical, mental or social functioning were measured in 25 RCTs.
“Physical, mental or social functioning were measured in 25 RCTs”
From Helping patients help themselves: A systematic review of self-management support strategies in primary health care practice (2019) · cites this paper as [54]
The Results section reports physical, psychological and social-relationship quality-of-life domains measured in this trial. The paper does not report that these outcomes were measured in 25 RCTs; it describes one cluster-randomised trial. (LLM, conf=0.87)
Experimental — accuracy not yet measuredChanges in perceived self-efficacy were reported in 14 studies.
“Changes in perceived self-efficacy were reported in 14 studies”
From Helping patients help themselves: A systematic review of self-management support strategies in primary health care practice (2019) · cites this paper as [54]
The Results (page unavailable) report a change in diabetes-management self-efficacy in this trial’s control group. The paper does not report that changes in perceived self-efficacy were found across 14 studies, so it supports the outcome but not the study count. (LLM, conf=0.86)
Experimental — accuracy not yet measuredTwenty-four RCTs examined the impact of interventions on health-related quality of life (HRQOL).
“Twenty-four RCTs examined the impact of interventions on HRQOL”
From Helping patients help themselves: A systematic review of self-management support strategies in primary health care practice (2019) · cites this paper as [54]
Self-care activities within 7 days were measured in 4 RCTs using the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire.
“Self-care activities within 7 days were measured in 4 RCTs [41, 52, 54, 60, 102, 103] using the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire”
From Helping patients help themselves: A systematic review of self-management support strategies in primary health care practice (2019) · cites this paper as [54]
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- Authors
- Browning, C., Chapman, A., Yang, H., Liu, S., Zhang, T., Enticott, J. C., & Thomas, S. A.
- Affiliations
- Monash University (AU)
- Peking University Cancer Hospital (CN)
- Peking University (CN)
- Corresponding author
- Chapman, Anna
- Venue
- BMJ Open
- Publisher
- BMJ
- Published
- 2016-03
- Volume
- 6
- Issue
- 3
- Pages
- e009319
- ISSN
- 2044-6055 (ISSN-L)
- PMC
- PMC4785304
- OpenAlex
- W2292805247
- Cited by
- 58
- References
- 32
- Citations by year
- 2026: 4 · 2025: 5 · 2024: 2 · 2023: 6 · 2022: 7 · 2021: 8 · 2020: 8 · 2019: 7 · 2018: 7 · 2017: 4
- FWCI
- 6.03
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by-nc
- Locations
- BMJ Open (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Monash University Research Portal (Monash University) (submittedVersion, cc-by-nc)
- FedUni ResearchOnline (Federation University Australia) (submittedVersion)
- Figshare (submittedVersion, cc-by-nc)
- HighWire Press Open Archive (submittedVersion)
- Funders
- Monash University
- Peking University
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- type 2 diabetes, health coaching, motivational interviewing, glycemic control, HbA1c, community health stations, primary care reform, psychological distress, blood pressure, lipid profile, self-care, China, usual care comparison, differential treatment effects, psychosocial outcomes, anthropometric outcomes, triglycerides, LDL cholesterol
- MeSH terms
- Aged, Blood Glucose, Blood Pressure, China, Communication, Counseling, Diabetes Mellitus, Type 2, Female, Glycated Hemoglobin, Humans, Cholesterol, LDL, Male, Middle Aged, Quality of Life, Regression Analysis, Self Care, Telephone, Multivariate Analysis, Treatment Outcome, Disease Management
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