Contact information
Type
Scientific
Primary contact
Prof Colette Browning
ORCID ID
Contact details
Building 1
270 Ferntree Gully Road
Notting Hill
3168
Australia
+61 (0)39902 4510
Colette.Browning@monash.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The Happy Life Club™ study: a cluster randomised controlled trial of a telephone and face-to-face coaching intervention to improve glycaemic control and metabolic, physiological and psychological profiles of patients with type 2 diabetes
Acronym
Study hypothesis
1. Primary objective:
To determine the effectiveness of the Happy Life Club™ intervention in improving the glycaemic control of participants at 6, 12 and 18 months compared with usual care.
2. Secondary objective:
To determine the effectiveness of the Happy Life Club™ intervention in improving the metabolic, physiological and psychological profiles of participants at 6, 12 and 18 months compared with usual care.
Ethics approval
The Monash University Human Research Ethics Committee, 03/06/2010
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
Type 2 diabetes
Intervention
Participants in the intervention group will receive a combination of both telephone and face to face health coaching over an 18 month period in addition to the same usual care received by participants in the control group. Health coaching will be performed by CHS doctors and nurses certified in coach assisted chronic disease management.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Change in HbA1c between baseline and 18 month follow up
Outcome measures will be assessed at 6, 12 and 18 months.
Secondary outcome measures
1. Clinical Health Check
1.1. Anthropometric measurements
1.2. Blood pressure
1.3. Total cholesterol
1.4. Triglyceride
1.5. Low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol levels
1.6. 2 hour postprandial glucose
1.7. Homocysteine
2. Self-administered questionnaire
2.1. Quality of life
2.2. Diabetes management self-efficacy
2.3. Diabetes self care activities
2.4. Psychosocial distress
2.5. Lifestyle factors
2.6. Self-rated health
Outcome measures will be assessed at 6, 12 and 18 months.
Overall trial start date
01/06/2011
Overall trial end date
01/06/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Community Health Stations:
1.1. All community health stations located in the Fengtai district of Beijing, China
2. Participants:
2.1. Previously diagnosed with type 2 diabetes
2.2. Aged 50 years and over
2.3. Reside in the Fengtai district of Beijing, China
2.4. Have an established health record and receiving care at one of the participating CHSs
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
A total sample of 720 participants is required from 42 Community Health Stations (an average of 17 participants per CHS) (updated on 28/06/2011; 1320 participants at time of registration)
Participant exclusion criteria
1. Inability to understand and provide informed consent
2. Medical condition that precludes adherence to recommendations (e.g. end stage cancer, severe mental illness)
Recruitment start date
01/06/2011
Recruitment end date
01/06/2013
Locations
Countries of recruitment
China
Trial participating centre
Building 1
Notting Hill
3168
Australia
Funders
Funder type
Government
Funder name
Chinese Centre for Disease Control and Prevention (China) - Fengtai District
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21303564
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26944692
Publication citations
-
Protocol
Browning C, Chapman A, Cowlishaw S, Li Z, Thomas SA, Yang H, Zhang T, The Happy Life Club™ study protocol: a cluster randomised controlled trial of a type 2 diabetes health coach intervention., BMC Public Health, 2011, 11, 90, doi: 10.1186/1471-2458-11-90.
-
Results
Browning C, Chapman A, Yang H, Liu S, Zhang T, Enticott JC, Thomas SA, Management of type 2 diabetes in China: the Happy Life Club, a pragmatic cluster randomised controlled trial using health coaches, BMJ Open, 2016, 6, 3, e009319, doi: 10.1136/bmjopen-2015-009319.