A Mhealth Social Support Program on Health Behaviors Among People at Risk of Metabolic Syndrome: a Feasibility Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Physical activity level
研究概览
简要总结
This trial is to examine the feasibility, acceptability, and preliminary effect of a mHealth social support program on lifestyle modifications among people at risk of metabolic syndrome in Hong Kong at 3- and 6-month follow-ups.
详细描述
Metabolic syndrome is a cluster of unhealthy conditions that affects more than 1 billion people in the world. Lifestyle modifications can reduce the risk to develop metabolic syndrome, while the report showed that over 95% of people in Hong Kong did not practice healthy lifestyle. This trial is to examine the feasibility, acceptability, and preliminary effect of a mHealth social support program on lifestyle modifications among people at risk of metabolic syndrome in Hong Kong. Eighty eligible participants will be recruited from community centers and be randomized into intervention group or control group. Participants in the control group will receive a mobile app with limited function, while those in the intervention group will receive a theory-guided mhealth social support program. Data will be collected at baseline, 3 months, and 6 months on the outcomes of feasibility, acceptability, and lifestyle modifications. Data will be analyzed using a generalized estimating equation based on the intention-to-treat principle. The findings of this study will provide valuable information for a full randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor will be blinded to the participants' group allocation throughout the study.
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese adults aged ≥ 45 years
- •With central obesity according to IDF criteria
- •Being treated of hypertension, dyslipidemia, or diabetes
- •Able to give informed consent
- •Attain at least 6 years of formal education
- •Have a smartphone with internet connection and able to use WhatsApp
排除标准
- •Concurrently participating in another clinical trial, lifestyle/dietary intervention, or weight control program
- •Known history of psychiatric disorders
结局指标
主要结局
Physical activity level
时间窗: Baseline, 3, and 6 months
Total exercise amount will be quantified with a modified version of the Godin-Shephard Leisure-Time Physical Activity Questionnaire.
次要结局
- Healthy eating(Baseline, 3, and 6 months)
- Self-efficacy(Baseline, 3, and 6 months)
- Waist circumference(Baseline, 3, and 6 months)
- Body fat mass percentage(Baseline, 3, and 6 months)
- Metabolic syndrome knowledge(Baseline, 3, and 6 months)
- Perceived social support(Baseline, 3, and 6 months)
- Blood pressure(Baseline, 3, and 6 months)
- Body weight(Baseline, 3, and 6 months)
研究者
Hon Lon Tam
Principal Investigator
Chinese University of Hong Kong