Vietnam Physical Activity and Nutrition Project: A community-based physical activity and nutrition intervention for adults with metabolic syndrome in Vietnam

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000811606
• Date of registration: 31/07/2014
• Prospective Registration: Yes
• Primary sponsor: WA Centre for Health Promotion Research, Curtin University
• 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
• Date of first enrolment: 10/09/2014
• Target sample size: 600
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614000811606.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Viet Nam

Contacts

• Name: Mr Van Dinh TRAN

• Name: Dr Jonine Jancey

Key inclusion & exclusion criteria

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).
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

Age minimum: 50 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Public Health - Health promotion/education

Metabolic syndrome;Type 2 diabetes mellitus;Cardiovascular disease;Overweight/obesity;
Metabolic syndrome
Type 2 diabetes mellitus
Cardiovascular disease
Overweight/obesity

Diet and Nutrition - Obesity

Metabolic and Endocrine - Metabolic disorders

Intervention(s)

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 b

Primary Outcome(s)

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. [After 6 month intervention]

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
[After 6 months intervention]

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.[After 6 months intervention]

Secondary Outcome(s)

Lipid profile (cholesterol, triglyceride)

The concentration of triglyceride, total cholesterol, HDL-C measured by fasting blood samples. [After 6 months intervention]

C-reactive protein (recognised measure of systemic inflammation) measured by using the serum from the same blood samples. [After 6 months intervention]

Insulin sensitivity (fasting insulin and glucose concentrations) measured by fasting blood samples.[After 6 months intervention]

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. [After 6 months intervention]

Secondary ID(s)

None

Source(s) of Monetary Support

School of Public Health Curtin University

Ethics review

Status: Approved
Approval date:
Contact:

Curtin University Human Research Ethics Committee

Results

• Results available: Yes
• Date Posted: 29/07/2019
• Date Completed: 30/12/2015