Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/11/2010
Date assigned
14/12/2010
Last edited
07/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

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

Sponsor details

3 Xi An Street
Fengtai District
Beijing
10007
China

Sponsor type

Research organisation

Website

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

  1. 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.

  2. 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.

Additional files

Editorial Notes

07/03/2016: Publication reference added.