Holistic Approach to Cardiometabolic Health and Obesity: Incretin-based Therapies, Nutrition, and Active Lifestyle
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Changes in muscle mass (bioimpedance scale)
研究概览
简要总结
The goal of this clinical trial is to evaluate whether combining a six-month structured lifestyle intervention (physical activity and nutrition) with incretin-based weight-loss medication improves preservation of muscle mass and physical function in adults living with obesity, compared with medication alone, and to assess the feasibility of a collaborative hospital-community care model.
This one-year pilot study will recruit 120 adults aged 18-70 years with obesity (BMI ≥30 kg/m² or ≥27 kg/m² with at least one comorbidity) receiving routine obesity care at the Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval. All participants will initiate physician-prescribed incretin-based therapy as part of standard care. The intervention group will receive medication plus a six-month structured lifestyle program delivered in collaboration with an exercise facility, including supervised strength-focused exercise and bi-monthly nutrition counseling, followed by a six-month consolidation phase. The control group will receive medication alone. Outcomes will be assessed at baseline and at 3, 6, and 12 months.
Participants will be randomly assigned in a 1:1 ratio to either the medication-only group or the combined medication and lifestyle intervention group. Participants randomized in the medication only group will receive a personalized consult with both a registered dietician and kinesiologist at the end of the study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 70 years
- •Prescribed, but not yet initiated, incretin-based pharmacotherapy [e.g., GLP-1 receptor agonist or dual GIP/GLP1 agonist] living with obesity, defined as:
- •BMI >30 kg/m2, or
- •BMI >27 kg/m2 with presence of comorbidities (e.g., type II diabetes, hypertension, hypercholesterolemia)
排除标准
- •Medical contraindications to physical activity practice (e.g., unstable cardiovascular disease, severe orthopedic limitation)
- •Prior or ongoing incretin-based therapy or history of bariatric surgery
- •Pregnancy, current breastfeeding or planned pregnancy during the study period
- •Implemented medical devices (e.g. pacemaker, defibrillator)
- •Chronic conditions affecting protein metabolism or nutrition (e.g., advanced kidney disease, active cancer)
研究组 & 干预措施
Medication alone
Participants will be randomly assigned to the incretin-based pharmacotherapy only.
干预措施: Incretin-Based Treatment (Drug)
Incretin-based pharmacotherapy combined with a 6-month lifestyle intervention
The intervention group will receive an incretin-based pharmacotherapy combined with a 6-month lifestyle intervention (weekly group exercise sessions, individual consultations with a kinesiologist and a registered dietitian every two months)
干预措施: Intervention (Behavioral)
结局指标
主要结局
Changes in muscle mass (bioimpedance scale)
时间窗: Baseline to 6 months
Muscle mass (kg)
Changes in muscular function (handgrip strength)
时间窗: Baseline to 6 months
Handgrip strength (kg)
Changes in muscular function (short physical performance battery)
时间窗: Baseline to 6 months
Short physical performance battery (balance, gait speed, lower-limb strength). Minimum: 0; Maximum: 12, with lower scores indicating poorer physical performance.
次要结局
- Changes in muscle mass (bioimpedance scale)(Baseline to 12 months)
- Changes in muscular function (handgrip strength)(Baseline to 12 months)
- Changes in muscular function (short physical performance battery)(Baseline to 12 months)
- Changes in nutrional intakes (Web-based 24-hour dietary recall)(Baseline to 6 months and baseline to 12 months)
- Changes in diet quality (Web-based 24-hour dietary recall)(Baseline to 6 months and baseline to 12 months)
- Changes in body composition (bioimpedance scale)(Baseline to 6 months and baseline to 12 months)
- Changes in body mass index (bioimpedance scale)(Baseline to 6 months and baseline to 12 months)
- Changes in visceral fat levels (bioimpedence scale)(Baseline to 6 months and baseline to 12 months)
- Changes in glycemic profiles (blood sample)(Baseline to 6 months and baseline to 12 months)
- Changes in lipid profiles (blood sample)(Baseline to 6 months and baseline to 12 months)
- Changes in hemodynamic measurements (sphygmomanometer)(Baseline to 6 months and baseline to 12 months)
- Changes in hepatic biomarkers (blood sample)(Baseline to 6 months and baseline to12 months)
- Changes in hepatic steatosis (transcient elastography)(Baseline to 6 months and baseline to 12 months)
- Changes in hepatic fibrosis (transcient elastography)(Baseline to 6 months and baseline to 12 months)
- Changes in physical activity participation (three-day physical activity record)(Baseline to 6 months and baseline to12 months)
- Changes in physical activity participation (step count)(Baseline to 6 months and baseline to 12 months)
- Changes in physical activity participation (exercise facility participation)(Baseline to 6 months and baseline to 12 months)
- Changes in eating behaviors (Adult Eating Behaviour Questionnaire)(Baseline to 6 months and baseline to 12 months)
- Changes in well-being, mood and Quality of Life (QLaval)(Baseline to 12 months)
- Feasibility of care model (adherence)(Baseline to 6 months and baseline to 12 months)
- Feasibility of care model (rentention)(Baseline to 6 months and baseline to 12 months)
- Feasibility of care model (satisfaction questionnaire)(Baseline to 6 months and baseline to 12 months)
研究者
Andréanne Michaud
Associate Professor
Laval University