Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000922673
Ethics application status
Approved
Date submitted
15/08/2014
Date registered
28/08/2014
Date last updated
8/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Health Promotion for people with or at high risk of Metabolic Syndrome
Scientific title
The effect of a health promotion program on health outcomes and health-promoting behavior of individuals with, or at high risk of metabolic syndrome: a randomized controlled trial
Secondary ID [1] 285180 0
Nil
Universal Trial Number (UTN)
U1111-1160-4432
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome 292778 0
Condition category
Condition code
Metabolic and Endocrine 293074 293074 0 0
Other metabolic disorders
Public Health 293130 293130 0 0
Health promotion/education
Diet and Nutrition 293131 293131 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to examine the effect of a health promotion program on health outcomes and health-promoting behavior of community-dwelling adults with, or at high risk of Metabolic syndrome in Hong Kong.

The intervention group will receive a 14-week health promotion program targeting on lifestyle changes. The program consists of 2 weekly 90-minutes group classes at week 1 and week 2. In the earlier section of the class (45 minutes), a nurse will deliver knowledge and information in regard to healthy lifestyle such as healthy eating and exercise. The latter section of the class (45 minutes), knowledge and skills required for a proper exercise regime will be demonstrated by a nurses and a exercise trainer. The nurse will meet participants individually in the intervention group during (week 5) and after (week 14) the health promotion program for a 15mins health counseling. A telephone reminder will also be made by the nurse to remind participants on healthy lifestyle and provide opportunities for asking questions at week 8 and week 10.
Intervention code [1] 290037 0
Lifestyle
Intervention code [2] 290085 0
Behaviour
Comparator / control treatment
The usual care group will receive a 15mins general health education on healthy eating and exercise that is consistent with public health campaigns individually by a nurse at week 5 (DH, HKSAR, 2011).
Control group
Active

Outcomes
Primary outcome [1] 292937 0
body weight will be measured to the nearest 0.1 kilogram using an electronic weight scale by a research assisstant
Timepoint [1] 292937 0
week 1, week 5, and week 14
Primary outcome [2] 292993 0
Waist Circumference will be measured to the nearest 0.1 centimeter using a measuring tape at the level of iliac crest with normal expiration by a research assisstant
Timepoint [2] 292993 0
week 1, week 5, and week 14
Secondary outcome [1] 309979 0
Health-promoting behaviors will be assessed using the Health-Promoting Lifestyle Profile II Chinese version in the format of a questionnaire.
Timepoint [1] 309979 0
week 1, week 5, and week 14
Secondary outcome [2] 310095 0
Blood Pressure will be taken using an calibrated electric blood pressure monitor by a research assisstant
Timepoint [2] 310095 0
week 1, week 5, and week 14
Secondary outcome [3] 310096 0
Fasting blood glucose will be obtain using the glucose oxidase method serum essay analysis performed in a qualified laboratory.
Timepoint [3] 310096 0
week 1 and week 14
Secondary outcome [4] 310097 0
Lipid profile [(Fasting Triglycerides, Total cholesterol, LDL-C (low-density lipoprotein Cholesterol) and HDL-C (high-density lipoprotein Cholesterol)] will be obtain using serum essay analysis performed in a qualified laboratory.
Timepoint [4] 310097 0
week 1 and week 14
Secondary outcome [5] 310098 0
Level of physical activity will be measured by using the International Physical Activity Questionnaire (Chinese version short-form) in the format of a questionnaire.
Timepoint [5] 310098 0
week 1, week 5, and week 14

Eligibility
Key inclusion criteria
Adults living in the community between the ages of 18 to 65, with two or more risk factors identified for Metabolic syndrome as specified according to the harmonized criteria published by AHA (Alberti et al., 2009).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants unable to read or speak Chinese, with known CVD, uncontrolled chronic diseases conditions, contraindications for exercise such as musculoskeletal diseases and neurovascular diseases, or had recent (<12 months) participation in other health promotion program will be excluded.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruitment of samples will be done by convenience sampling through community centers. Half of these centers were randomly allocated to the intervention group using a computer-generated randomization. Allocation is not concealed due to the study design that involves recruitment at the cluster-level. Potential participants will be contacted by the researcher and received basic health screening to verify status of MS. After obtaining written consents, eligible participants meeting the inclusion and exclusion criteria will be recruited.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated randomization at cluster level
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Cluster-randomized
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All statistical analyses will be performed using the commercial statistical package SPSS 19.0 and a significance level of 0.05 will be considered statistically significant. Descriptive statistics such as percentages, means, medians, standard deviations will be used to present the demographics of the participants along with their 95% confidence intervals. Pearson or Spearmans’ correlation and Chi-square statistics will be used to examine the relationships between continuous and categorical variables respectively. Repeated measures ANOVA will be used to test the difference among matched outcomes across time. Independent t-test and Mann Whitney U tests will be used for investigating the intervention effects according to the measurement scales. All analyses shall be done according to intention-to-treat principle. Where appropriate, multiple regressions will be used to explore correlations across variables according to the modified HBM.

The estimated sample size will be based on previous literature considering the detected differences between the intervention and control group on the outcomes of this proposed study. Being conservative, the expected change shall have a medium effect size of 0.5 and the attrition rate shall be approximately 20%. Therefore, a minimum of 80 participants in each group will be needed in order to detect differences between two groups on 80% power at 0.05 significance level

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/06/2013
Actual
24/06/2013
Date of last participant enrolment
Anticipated
17/05/2014
Actual
17/05/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
183
Recruitment outside Australia
Country [1] 6296 0
Hong Kong
State/province [1] 6296 0

Funding & Sponsors
Funding source category [1] 289790 0
Charities/Societies/Foundations
Name [1] 289790 0
Hong Kong Health Check Charity Fund
Country [1] 289790 0
Hong Kong
Primary sponsor type
Individual
Name
Lo Wai Sze
Address
8/F, Esther Lee Building, The Chinese University of Hong Kong, Sha Tin, NT, Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 288482 0
None
Name [1] 288482 0
Address [1] 288482 0
Country [1] 288482 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291527 0
The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee
Ethics committee address [1] 291527 0
Ethics committee country [1] 291527 0
Hong Kong
Date submitted for ethics approval [1] 291527 0
06/05/2013
Approval date [1] 291527 0
23/06/2013
Ethics approval number [1] 291527 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50746 0
Ms Lo Wai Sze
Address 50746 0
8/F Esther Lee Building, The Chinese University of Hong Kong, Sha Tin, NT
Country 50746 0
Hong Kong
Phone 50746 0
+852 39434335
Fax 50746 0
Email 50746 0
[email protected]
Contact person for public queries
Name 50747 0
Lo Wai Sze
Address 50747 0
8/F Esther Lee Building, The Chinese University of Hong Kong, Sha Tin, NT
Country 50747 0
Hong Kong
Phone 50747 0
+852 39434335
Fax 50747 0
Email 50747 0
[email protected]
Contact person for scientific queries
Name 50748 0
Lo Wai Sze
Address 50748 0
8/F Esther Lee Building, The Chinese University of Hong Kong, Sha Tin, NT
Country 50748 0
Hong Kong
Phone 50748 0
+852 39434335
Fax 50748 0
Email 50748 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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