None listed
Conditions
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.
Interventions
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
Sponsors
Study design
Eligibility
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