The Happy Life Club™ study: a cluster randomised controlled trial of a type 2 diabetes health coach intervention

ISRCTN	ISRCTN01010526
DOI	https://doi.org/10.1186/ISRCTN01010526
Secondary identifying numbers	N/A

Submission date: 03/11/2010
Registration date: 14/12/2010
Last edited: 05/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Colette Browning
Scientific

Building 1
270 Ferntree Gully Road
Notting Hill
3168
Australia

Phone	+61 (0)39902 4510
Email	Colette.Browning@monash.edu

Study information

Study design	Cluster randomised controlled trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a patient information sheet
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
Study objectives	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(s)	The Monash University Human Research Ethics Committee, 03/06/2010
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/06/2011
Completion date	01/06/2013

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	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)
Key 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
Key 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)
Date of first enrolment	01/06/2011
Date of final enrolment	01/06/2013

Locations

Countries of recruitment

Australia
China

Study participating centre

Building 1

Notting Hill
3168
Australia

Sponsor information

Chinese Centre for Disease Control and Prevention (China) - Fengtai District
Research organisation

3 Xi An Street
Fengtai District
Beijing
10007
China

"ROR"	https://ror.org/04wktzw65

Funders

Funder type

Government

Chinese Centre for Disease Control and Prevention (China) - Fengtai District

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	09/02/2011	Yes	No
Results article	results	04/03/2016	Yes	No
Results article	results	19/09/2018	Yes	No

Editorial Notes

05/10/2018: Publication reference added.
07/03/2016: Publication reference added.