Development and Effectiveness of an Innovative Care Model Integrating Mobile Health Support to Promote Weight Management in Adults With Overweight or Obesity: A Stepped-wedge Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 876
- 试验地点
- 3
- 主要终点
- Change in weight
研究概览
简要总结
The objective of this clinical trial is to evaluate whether an innovative care model integrating mobile health (mHealth) support improves weight management in adults with overweight or obesity. The primary research questions are: (1) Does the intervention promote weight change at the 6-month follow-up? (2) Does the intervention enhance physical activity and encourage a healthy diet at the 3- and 6-month follow-ups?
To address these questions, researchers will compare the intervention group with a control group to measure changes in weight, physical activity, and dietary habits.
At baseline, all participants will complete a survey assessing demographics, body weight, height, central obesity, lifestyle, weight loss history, and expectations. The intervention group will receive a weight management program based on Ecological Momentary Assessment (EMA), incorporating risk-stratified health services, with follow- ups at 3 and 6 months. The control group will receive minimal intervention in the form of general health advice, with follow-ups at the same intervals.
详细描述
Background: Obesity leads to cardiovascular diseases, diabetes, musculoskeletal disorders, and many types of cancers. Insufficient physical activity and unhealthy diet (including high intake of saturated fatty acids, fat and inadequate consumption of dietary fibre) are the major causes of obesity but they are preventable and reversible.
The Population Health Survey 2020-22 showed that the overall prevalence of overweight and obese (level 1 and 2) in Hong Kong is 22.0% and 32.6%, respectively. The age-standardized prevalence of physical inactivity has risen from 12.4% (crude prevalence: 13.0%) in 2014-15 to 24.8% in 2020-22. Still 1,486,000 HK residents aged 18 years or above had not met the recommended physical activities level by World Health Organization (WHO). About 4.6% of the population have raised blood glucose or diabetes in 2020-22, compared to 3.9% in 2014-15. The age-standardized prevalence of raised total cholesterol has risen from 38.4% in 2014-15 to 46.5% in 2020-22. About 39.1% of the population eat red meat at least once every day, but only 1.5% of the population intake 2 standard bowls of fruits and 3 bowls of vegetables.
The government targets to reduce a relative 10% of prevalence of physical inactivity by 2025 (compared to 2018) and halt the rise in obesity. The Hong Kong government has been promoting physical activity and healthy diet through public education and social marketing campaigns, but local routine primary healthcare service providers, including Hospital Authority (HA), District Health Centres (DHCs) and non-governmental organizations (NGOs), do not have standard protocols for assessing behavioral risk factors and delivering effective intervention for physical activity and healthy diet.
Mobile Health (mHealth) intervention is a novel and cost-effective approach to increase physical activity, which was highly supported by the WHO. A meta-analysis showed that mHealth intervention was associated with an increase of physical activity at short-(≤ 3 months, by 506 steps per day, 95%CI= -80 to 1092) and long-term (≥6 months, by 753 steps per day, 95%CI= -147 to 1652) follow-up. The meta-analysis also showed that intervention can reduce sedentary time at short-term (≤ 3 months, standardized mean differences (SMDs)=-0.49, 95%CI= -1.02 to 0.03) follow-up but the result was not statistically significant. However, most apps cannot provide personalized intervention and their intervention do not involve behavior change techniques. A qualitative study showed 45.4%of users of smartphone apps disagreed or strongly disagreed that text messages promote them to do more physical activity since those messages did not match their motivation.
To capture the facilitators, barriers, and behaviors in naturalistic settings, ecological momentary assessment (EMA) using mobile devices was developed in recent years. During EMA, users are repeatedly prompted to provide simple information about their experiences and/or behaviors at predetermined and/or random intervals throughout the day. The advantage of EMA includes lower recall bias and providing information at different times of the day. Based on EMA summaries, healthcare professionals could design more personalized interventions. EMA information also enables the provision of ecological momentary intervention (EMI), which the software collecting EMA automatically analyze EMA data and provide tailored messages, potentially improving user engagement and compliance to the intervention. EMA and EMI have been adopted in improving mental health, smoking cessation, and reducing substance use with promising results, but interventions for weight management were still under development
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hong Kong residents aged ≥18 years;
- •able to read and communicate in Chinese;
- •own a smartphone with internet access;
- •have good mobility alone without gait aid;
- •body mass index ≥ 23.0;
- •and no contraindication for physical activity as evidenced by: If aged < 70: do not meet any criteria in PAR-Q, or sign declaration of having medical clearance if meet any criteria in PAR-Q; If aged ≥ 70: sign the declaration about conducting physical activity frequently or having medical clearance
排除标准
- •Have a terminal illness (e.g., advanced cancer, dementia, pulmonary, neurological, motor-neuron, and advanced cardiovascular disease) or with a life expectancy of less than 6 months;
- •currently receiving treatment for any cancer (active cancer patients) or cancer survivor of any GI cancers (e.g. colorectal cancer, stomach cancer);
- •lactating, pregnant or planning for pregnancy in the coming 6 months;
- •have current diagnosis of psychiatric disorder;
- •have previous diagnosis of eating disorder;
- •have diagnoses of gastrointestinal conditions (e.g. Irritable Bowel Syndrome, Ulcerative Colitis, Crohn's Disease, Coeliac Disease);
- •currently receiving intensive diet or exercise treatment;
- •have clinical obesity (e.g. confirmation of excess body fat plus limitations of day-to-day activities or signs or symptoms of obesity-related organ dysfunction). Examples of obesity-related organ dysfunction include NAFLD with hepatic fibrosis, the cluster of hyperglycaemia, high triglyceride levels, and low HDL cholesterol levels. Examples of limitations of day-to-day activities include significant age-adjusted limitations of mobility and/or other basic ADL (e.g. bathing, dressing, toileting, continence, eating).
研究组 & 干预措施
Control group intervention
Participants in the control group will receive minimal Intervention. They will not be provided with risk-stratified services.
干预措施: Minimal Intervention (Behavioral)
EMA-based weight management intervention
Participants in the intervention group will join an mobile health (mHealth) weight management program integrating ecological momentary assessment (EMA) via a mobile app, post-EMA counseling, and risk-stratified coaching. This program provides real-time monitoring and personalized feedback to improve diet and physical activity.
干预措施: EMA-based weight management intervention (Behavioral)
结局指标
主要结局
Change in weight
时间窗: 6-month from baseline
Defined as the change in weight of participants over a specified period, this measurement compares the weight change between the intervention and control groups. Participants' weights will be recorded in kilograms at baseline and at a 6-month follow-up using a calibrated digital scale.
次要结局
- Proportion of participants with ≥5% weight change(3-, 6- and 12-month follow-up from baseline)
- Change in waist-to-hip ratio(3-, 6-, & 12-month follow-up from baseline)
- Change in weight(3- and 12-month from baseline)
- Proportion of overweight or obesity(3-, 6- and 12-month follow-up from baseline)
- Change in body fat(3- and 6-month follow-up from baseline)
- Change in muscle mass(3- and 6-month follow-up from baseline)
- Change in waist circumference(3-, 6-, and 12-month follow-up from baseline)
- Change in self-report time of physical inactivity(3- and 6-month follow-up from baseline)
- Change in self-report time of moderate to vigorous physical activities (MVPA)(3- and 6-month follow-up from baseline)
- Change in diet consumption(3- and 6-month follow-up from baseline)
- Dietary adherence to government guideline(3- and 6-month follow-up from baseline)
- Change in daily step counts(3- and 6-month follow-up from baseline)
- Change in lipid profile(6-month follow-up from baseline)
- Proportion of elevated blood glucose(6-month follow-up from baseline)
- EMA compliance(baseline)
- Compliance to the counselling(Day 15)
- Perception and attitude toward the project(6-month follow-up)
研究者
Prof. Sophia Siu-chee Chan
Professor
The University of Hong Kong