Effectiveness and Implementation of a Community-based Health Coach-led Artificial Intelligence (AI)-Powered Digital Self-Regulation Program for Individuals With Metabolic Syndrome (MetS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- Self regulation of Eating Behaviour Questionnaire (SREBQ)
研究概览
简要总结
This study aims to evaluate the effectiveness of the Lifestyle Intervention for Gentle, Healthy Transformation and Enhanced Weight Reduction-metabolic syndrome (LIGHTER-MetS) program on dietary self-regulation and cardiovascular risk among individuals with metabolic syndrome (MetS). The LIGHTER-MetS program, a community-based, grassroots-led initiative, integrates health coaching with the eTRIP© app to promote sustainable lifestyle changes focusing on diet, exercise, and emotion regulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are between 21 to 65 years of age;
- •have a waist circumference ≥90 cm in men and ≥80 cm in women;
- •have 2 or more of the following to be classified as having metabolic syndrome:
- •triglyceride level of ≥1.7 mmol/L or on specific treatment for this lipid abnormality;
- •high density lipoprotein (HDL) cholesterol <1.03 mmol/L in men, and <1.29 mmol/L in women, or on specific treatment for this lipid abnormality;
- •blood pressure of ≥130/85 mmHg or on treatment of previously diagnosed hypertension;
- •fasting blood glucose level of ≥ 5.6 mmol/L or previously diagnosed type 2 diabetes;
- •are not receiving other structured lifestyle modification programs;
- •consent to audio-recording;
- •English speaking and literate.
排除标准
- •underwent or are scheduled for metabolic surgery within 1 year;
- •are pregnant or planning for pregnancy at the time of recruitment;
- •are unable to speak English;
- •do not own a smartphone; and
- •are unable to provide informed consent.
研究组 & 干预措施
Control
Participants will receive personalised health plans provided as part of usual care when they see a family physician. As part of the HealthierSG initiative, health plans are typically formulated to target early disease prevention and chronic condition management through history taking, physical examination, appropriate diagnostic testing, treatment, referrals and lifestyle modification goals and activity planning.
LIGHTER-MetS
The LIGHTER-MetS program includes community-based health coaching by the PI or a trained healthcare professional (e.g. nurse, physiotherapist etc.) at baseline visit and for 3 months following the baseline visit. Throughout the first 3 months, participants will also use the eTRIP© app to log meals, monitor physical activity, and receive personalized feedback. During the 3-month intervention period, there will be one-to-one slots for the health coach to follow up on participants' health plan.
干预措施: LIGHTER-MetS (Behavioral)
结局指标
主要结局
Self regulation of Eating Behaviour Questionnaire (SREBQ)
时间窗: At baseline, 3, 6, and 12 months.
The Self-Regulation of Eating Behaviour Questionnaire (SREBQ) is a validated self-administered instrument used to assess individuals' self-regulation in relation to eating behavior. It evaluates the extent to which individuals monitor, control, and regulate their eating behaviors in everyday contexts. Higher scores indicate greater self-regulation of eating behavior.
Cardiovascular Risk
时间窗: At baseline, 3, 6, and 12 months.
Cardiovascular risk will be assessed via the ASCVD-risk calculator and the Singapore-modified Framingham Risk Score 2023 (SG-FRS-2023). Higher scores indicate a greater estimated cardiovascular risk.
次要结局
- Weight(At baseline, 3, 6, and 12 months.)
- Waist Circumference(At baseline, 3, 6, and 12 months.)
- Blood Pressure(At baseline, 3, 6, and 12 months.)
- Patient Health Questionnaire-2 (PHQ-2)(At baseline, 3, 6 and 12 month.)
- Three Factor Eating Questionnaire (TFEQ)(At baseline, 3, 6 and 12 month.)
- Consideration of Future Consequences Scale (CFCS-6)(At baseline, 3, 6 and 12 month.)
- Self-Report Behavioural Automaticity Index (SRBAI)(At baseline, 3, 6 and 12 month.)
- International Physical Activity Questionnaire Short-Form (IPAQ-SF)(At baseline, 3, 6 and 12 month.)
- Generalized Anxiety Disorder 2-item (GAD-2)(At baseline, 3, 6 and 12 month.)
- Perceived Stress Scale (PSS-10)(At baseline, 3, 6 and 12 month.)
- Euro Quality of life 5 Dimensions-5 Levels (EQ-5D-5L)(At baseline, 3, 6 and 12 month.)
- Big Five Inventory - 44 item (BFI-44)(At baseline, 3, 6 and 12 month.)
- BMI(At baseline, 3, 6 and 12 month.)
- Percentage Body Fat(At baseline, 3, 6 and 12 month.)
- Body Fat Mass(At baseline, 3, 6 and 12 month.)
- Visceral Fat Level(At baseline, 3, 6 and 12 month.)
- Homeostatic Model Assessment of Insulin Resistance(At baseline, 3 and 12 months.)
- Fasting Blood Glucose (mmol/L)(At baseline, 3, 6 and 12 month.)
- Glycated haemoglobin (HbA1c) (%)(At baseline, 3, 6 and 12 month.)
- Triglycerides (mmol/L)(At baseline, 3, 6 and 12 month)
- High-density lipoprotein cholesterol (HDL-C) (mmol/L)(At baseline, 3, 6 and 12 month.)
研究者
Jocelyn Chew
Assistant Professor
National University Health System, Singapore