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Trial registered on ANZCTR


Registration number
ACTRN12614000811606
Ethics application status
Approved
Date submitted
14/07/2014
Date registered
31/07/2014
Date last updated
31/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Vietnam Physical Activity and Nutrition Project: A community-based physical activity and nutrition intervention for adults with metabolic syndrome in Vietnam
Scientific title
A cluster-randomised controlled trial to evaluate the effect of a community-based lifestyle intervention on physical activity and dietary measures in Vietnamese adults aged 50-65 years with metabolic syndrome in a province in North Vietnam
Secondary ID [1] 284983 0
None
Universal Trial Number (UTN)
Trial acronym
VPAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic syndrome 292487 0
Type 2 diabetes mellitus 292519 0
Cardiovascular disease 292520 0
Overweight/obesity 292521 0
Condition category
Condition code
Diet and Nutrition 292796 292796 0 0
Obesity
Public Health 292797 292797 0 0
Health promotion/education
Metabolic and Endocrine 292798 292798 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention strategies for this community-based program are designed to inform participants of the benefits of being physically active and maintaining a healthy diet as a means of preventing chronic disease (outcome expectation). Positive reinforcement (incentives and motivation), by way of encouragement and feedback, will be facilitated through the trained community group leaders. The setting of realistic and personal physical activity goals, as well as opportunities to learn about and practice new skills (e.g. education and walking groups) will be provided. Observational learning (seeing others being active) and environmental supports via the involvement of family, friends and peers in the program, will further enhance positive behavioural changes. The communes provide an ideal environment to observe the adoption of healthy lifestyle behaviours and build social and physical environmental supports.

This community-based intervention will include the following strategies. All components will be conducted within the same commune where the participant resides to minimise subject burden.
a. Education sessions
The participants (n=100) in each intervention commune will be divided into four groups, i.e. 25 participants per group. Each group will attend four 2-hour education sessions on healthy diet and physical activity in months 1, 2, 3, 4 of the program held at the local commune health centres. Sessions will be participatory and interactive, rather than didactic. Small group activities will foster problem solving, social support, and program ownership.

b. Booklet
At the first education session, each participant will be provided with a booklet (in Vietnamese) designed to inform and support improvements in nutritional intake and physical activity behaviours. This booklet will be adapted from previously developed materials used in the Physical Activity and Nutrition for Seniors (PANS) project and modified to ensure suitability for the Vietnamese context. The educational materials will be simple, short, and easy to understand. The first section will introduce the program as well as the benefits of physical activity and a healthy diet. The second section will focus on various modes of physical activity, and contain illustrations and tips on how to perform physical activity (e.g. brisk walking) correctly and resistance, weight training and stretching exercises safely. The third section will comprise suggested meal plans, recipes, and tips for healthy eating, encouraging a higher consumption of fruits and vegetables and fibre while reducing intake of saturated fat, salt, and sugar. The last section will provide information on the barriers to physical active and healthy eating and how to overcome them.

c. Walking groups and walk leaders
Three walking groups per commune will be established immediately after the first education session. The walking groups serve to mobilise the participants, supporting them to meet and walk together in order to achieve the physical activity guidelines for health benefits.
A walk leader in each walking group will be identified, who will be either a local middle-aged volunteer or the village health worker within the commune. The walk leaders are required to be enthusiastic, demonstrate leadership qualities, and respected by other people in the commune.
A 25-week prescriptive progressive physical activity program will be provided by the 9 group leaders, supported by clear explanations and illustrations of stretching and resistance exercises. The weekly walking will be increased gradually from only 5 minutes per day in the first week to 40 minutes per day in the weeks of 6th month. The walk leaders will guide the participants but have the flexibility to modify the prescribed program to suit individual needs, such as walking less or more, within their group.

d. Resistance exercises
Each participant will be provided with a resistance band. Simple gym equipment such as light free-weights, skipping ropes and gym balls will be placed in the commune health centres to foster group training. Detailed instructions on using such equipment, warming up and exercise techniques, as well as how to develop their own personal physical activity goals and plan will be disseminated during the education sessions.
It is not intended to be a strenuous weight training program. To encourage participation in the exercise component, the walk leaders will endeavour to take their entire group to the commune health centre once a week. Regular maintenance and checking of the gym equipment will be assured by local research assistants to enable long term sustainability of the exercise program
Intervention code [1] 289811 0
Lifestyle
Intervention code [2] 289812 0
Behaviour
Intervention code [3] 289814 0
Prevention
Comparator / control treatment
The control group will be placed in a waitlist. They will be received the intervention after the post-test data collection have been completed.
Control group
Active

Outcomes
Primary outcome [1] 292649 0
Physical activity: intensity, duration, and frequency (both self-report and objective).
Physical activity will be measured using the Vietnamese validated IPAQ-SF questionnaire and ActiLife 6 Accelerometers.
Timepoint [1] 292649 0
After 6 months intervention
Primary outcome [2] 292650 0
Self-reported dietary behaviours, specifically fat, oil, sugar, salt, fruit and vegetable consumption.
The brief dietary habit questionnaire is adapted from the STEPS developed by the WHO.
Timepoint [2] 292650 0
After 6 month intervention
Primary outcome [3] 292651 0
Waist circumference
Waist circumference will be measured stading up at the level midway between the lowest rib margin and the iliac crest to the nearest 0.5cm by certified anthropometrists
Timepoint [3] 292651 0
After 6 months intervention
Secondary outcome [1] 309415 0
Insulin sensitivity (fasting insulin and glucose concentrations) measured by fasting blood samples.
Timepoint [1] 309415 0
After 6 months intervention
Secondary outcome [2] 309416 0
Lipid profile (cholesterol, triglyceride)

The concentration of triglyceride, total cholesterol, HDL-C measured by fasting blood samples.
Timepoint [2] 309416 0
After 6 months intervention
Secondary outcome [3] 309417 0
C-reactive protein (recognised measure of systemic inflammation) measured by using the serum from the same blood samples.
Timepoint [3] 309417 0
After 6 months intervention
Secondary outcome [4] 309418 0
Blood pressure
Blood presure will be measured by a physician or a trained nurse with an Omron M5-1 electronic sphygmomanometer. A mean value will be recorded after three consecutive measurement.
Timepoint [4] 309418 0
After 6 months intervention

Eligibility
Key inclusion criteria
The participants will be required to be 50-65 years, low physical activity (less than 150 minutes of moderate physical activity per week), overweight/obesity (Body-mass index (BMI) greater than or equal to 23 (Asian population), and includes any 3 of the following 5 risk factors:
Waist circumference (male greater than or equal to 90 cm, female greater than or equal to 80 cm for Asia Population); Raised triglycerides (greater than or equal to 1.7 mmol/L or 150 mg/dL); Reduced HDL-cholesterol (less than 1.03 mmol/L or 40 mg/dL for males, less than 1.29 mmol/L or 50 mg/dL for females); Raised blood pressure (systolic greater than or equal to 130 mmHg or diastolic greater than or equal to 85 mmHg); Raised plasma glucose (fasting plasma glucose greater than or equal to 6.1 mmol/L).
Minimum age
50 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who have received treatment for T2DM, CVD, hypertension, raised lipid profile, raised glucose, have taken part in any dietary and/or physical activity program within the past year, and be suspected to be diabetic (fasting plasma glucose greater than or equal to 7.0mmol/L or greater than 126mg/dL) will be excluded

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Step 1: Screening
Potential participants will be invited to attend their local commune health centre to have their height and weight measured. A screening interview, seeking basic information on age, gender and physical activity sufficiency, will be administered face-to-face using a brief questionnaire. Body-mass index (BMI) will be classified using the cut-off points for Asian populations recommended by the WHO: less than 18.5, underweight; 18.5 to less than 23, normal weight; 23–27.5, overweight; greater than 27.5, obese. Individuals who have received treatment for T2DM, CVD, hypertension, raised lipid profile, raised glucose, or have taken part in any dietary and/or physical activity program within the past year will be excluded

Step 2: Determining MetS status
Overweight/obese individuals who appear to be physically inactive (less than 150 minutes moderate activity per week) from the screening will be subsequently invited for a blood test and have their waist circumference, hip circumference and blood pressure measured.
Blood test: A single fasting blood sample will be collected and analysed to determine fasting plasma glucose, triglycerides, total cholesterol, and HDL cholesterol. Based on these results, people suspected to be diabetic (fasting plasma glucose greater than or equal to 7.0mmol/L or greater than 126mg/dL) will be excluded from the study and will be recommended to go to a hospital for confirmation of T2DM instead.
MetS status will be determined using the ATP III definition criteria, which includes any 3 of the following 5 risk factors:
1. Waist circumference (male greater than or equal to 90 cm, female greater than or equal to 80 cm for Asia Population);
2. Raised triglycerides (greater than or equal to 1.7 mmol/L or 150 mg/dL);
3. Reduced HDL-cholesterol (less than 1.03 mmol/L or 40 mg/dL for males, less than 1.29 mmol/L or 50 mg/dL for females);
4. Raised blood pressure (systolic greater than or equal to 130 mmHg or diastolic greater than or equal to 85 mmHg);
5. Raised plasma glucose (fasting plasma glucose greater than or equal to 6.1 mmol/L).
It is expected 100 potential participants with MetS per commune will be eligible to enrol in the study. Additional measurement of fasting insulin and C-reactive protein using the serum from the same blood samples will allow assessment of insulin sensitivity and inflammation respectively.

Step 3: Allocation into control and intervention groups
The six communes will be randomly allocated to the intervention and ‘wait-listed’ control groups (3 communes each), giving a total of 600 participants at baseline evaluation. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The six communes will be randomly allocated to the intervention and ‘wait-listed’ control groups (3 communes each), which are geographically separated to avoid contamination and information exchange between groups, giving a total of 600 participants at baseline evaluation. Simple randomisation using coin-tossing procedures will be used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
In addition to descriptive statistics, generalised mixed regression models will be fitted to the repeated measures to evaluate the magnitude of the changes and associated effect sizes. Comparisons between the intervention group and the control group over time will be made via multivariate methods, taking into account the correlated data structure and the presence of missing observations, while intention-to-treat analysis will be undertaken to account for sensitivity of the inferences. All data entry and statistical analyses will be performed in the SPSS version 21

Qualitative data: The qualitative data (recordings) will be transcribed. Data will be coded and themese for the purposes of the study created. The NVivo software will be used to manage and analyise the qualitative data.

The power calculations are based on a logistic mixed regression model with the outcome variable being the prevalence of moderate activity participation. To allow for 80% complete data across the two assessments due to attrition and withdrawals, a total of n equals to 600 participants with MetS will be initially recruited at baseline. In the power analysis, the effect size of interest is associated with the time (pre-post) and intervention group parameters. For mixed regression adjusting for the clustering (communes), a final sample size of n equals to 500 [125 per gender by intervention condition] will provide sufficient power (80%) to detect a medium effect size (increase of 10% in moderate activity prevalence) at 5% significance level for the group by time interaction accounting for gender but without other covariate adjustment.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6214 0
Viet Nam
State/province [1] 6214 0
Hanam

Funding & Sponsors
Funding source category [1] 289598 0
University
Name [1] 289598 0
School of Public Health
Curtin University
Address [1] 289598 0
Curtin University, Kent St Bentley WA, 6102
Country [1] 289598 0
Australia
Primary sponsor type
University
Name
WA Centre for Health Promotion Research, Curtin University
Address
Curtin University, Kent St Bentley WA, 6102
Country
Australia
Secondary sponsor category [1] 288282 0
None
Name [1] 288282 0
Address [1] 288282 0
Country [1] 288282 0
Other collaborator category [1] 278055 0
Government body
Name [1] 278055 0
National Institute of Hygiene and Epidemiology
Address [1] 278055 0
No 1, Yersin, Hanoi, 10000
Country [1] 278055 0
Viet Nam

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291334 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 291334 0
Kent St Bentley WA 6102
Ethics committee country [1] 291334 0
Australia
Date submitted for ethics approval [1] 291334 0
Approval date [1] 291334 0
10/07/2014
Ethics approval number [1] 291334 0
HR139/2014

Summary
Brief summary
Metabolic syndrome (MetS) is a cluster of risk factors, including abdominal obesity, elevated blood pressure, dyslipidemia, impaired glucose tolerance, and insulin resistance. Such risk factors are known to be associated with non-communicable diseases (NCD) in many populations. It is estimated that almost one-quarter of the adult population worldwide have MetS.

Vietnam is a developing country with rapid economic growth in recent decades. NCD are becoming more prevalent due to lifestyle changes. MetS is now a major public health problem, with high prevalence particularly in urban areas. It is estimated that 18.1% of Vietnamese adults aged 35-65 years old have MetS and the rate appears to increase with age. Modifiable lifestyle factors, such as inadequate levels of physical activity and poor dietary habits, are associated with the development of MetS.

This 6-month cluster-randomised controlled trial (RCT) aims to develop, implement, and evaluate a community-based physical activity and nutrition intervention for Vietnamese adults aged 50 to 65 years identified as having MetS. This RCT will actively promote increases in levels of physical activity, strength exercises and a healthy diet via a community-based intervention through a range of strategies. A total of 600 participants with MetS from 6 randomly selected communes in Hanam province in North Vietnam will be recruited and allocated into intervention and control groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49942 0
Prof Andy Lee
Address 49942 0
School of Public Health
Curtin University
Kent St Bentley WA 6102
Country 49942 0
Australia
Phone 49942 0
+61892664180
Fax 49942 0
Email 49942 0
Andy.Lee@curtin.edu.au
Contact person for public queries
Name 49943 0
Mr Van Dinh TRAN
Address 49943 0
Department of Community Health and Network Coordination
National Institute of Hygiene and Epidemiology
No. 1, Yersin St, Hanoi
Country 49943 0
Viet Nam
Phone 49943 0
+84439710791
Fax 49943 0
Email 49943 0
vandinh.tran@postgrad.curtin.edu.au
Contact person for scientific queries
Name 49944 0
Dr Jonine Jancey
Address 49944 0
School of Public Health
Curtin University
Kent St Bentley WA 6102
Country 49944 0
Australia
Phone 49944 0
+61892663807
Fax 49944 0
Email 49944 0
j.jancey@curtin.edu.au

No information has been provided regarding IPD availability
Summary results
No Results