Multiple Risk Factor Intervention Trial: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Physical activity intervention feasibility
研究概览
简要总结
Ms. FIT pilot is a pilot study of a 3-arm RCT with equal recruitment and stratification of pre and postmenopausal women with risk factors for chronic disease to: 1) Canadian guidelines-based physical activity alone; 2) Canadian guidelines-based physical activity and healthy eating; or 3) stretching attention control. The purpose of this study is to evaluate the feasibility, acceptability, and preliminary efficacy of the interventions. The objectives are to: 1) pilot test the intervention delivery protocol in a real-world application (management and technical capabilities of the research group); 2) evaluate adherence and participant acceptability of a combined in-person and virtual intervention delivery in both pre and post-menopausal women; 3) identify the preliminary efficacy of the interventions on select cardiometabolic risk markers.
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
It is not possible to blind participants to their assigned intervention. Care providers are not involved. The outcome assessors for any assessments involving potential for subjectivity in data collection or analysis will be blinded to group assignment.
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pre- or postmenopausal
- •aged 30+ years
- •moderate or high Canadian Diabetes Risk Score score
排除标准
- •diagnoses of cardiovascular diseases, type 2 diabetes, non-alcoholic fatty liver disease, cancer (except for non-melanoma skin cancer), or respiratory disease (i.e., COPD)
- •major signs or symptoms (regardless of known diagnosis) of cardiovascular diseases, diabetes, or renal disease
- •pregnant or lactating
- •mobility limitations to exercise
- •smoking cigarettes within the past 3 months
- •using transdermal hormones, taking exogenous hormones or receiving exogenous hormones from other means (e.g. intrauterine device)
- •self-report of >30 min/week of MVPA
- •following a specific dietary practice (e.g., vegan, ketogenic) in last 3 months
- •presenting with any of the American Heart Association's absolute or relative contraindications for symptom-limited maximal exercise testing
- •requiring and do not receive medical clearance for maximal exercise
- •cannot read and understand the consent form or communicate in English
- •individuals who are students in classes of the professors who are involved in the study or students with whom the professors have a supervisory relationship
研究组 & 干预措施
Guidelines-based physical activity and healthy eating
150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening + counselling to follow Canada's Food Guide
干预措施: Experimental: Guidelines-based physical activity (Behavioral)
Guidelines-based physical activity and healthy eating
150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening + counselling to follow Canada's Food Guide
干预措施: Experimental: Guidelines-based healthy eating (Behavioral)
Guidelines-based physical activity
150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening
干预措施: Experimental: Guidelines-based physical activity (Behavioral)
Stretching exercise
Whole-body stretching
干预措施: Stretching exercise (Behavioral)
结局指标
主要结局
Physical activity intervention feasibility
时间窗: end of week 6
Determined as an average adherence to physical activity guidelines of ≥100% measured via Garmin smartwatch
Diet quality intervention feasibility
时间窗: end of week 6
Determined as a 5-point improvement in diet quality measured via healthy eating index from 3-day diet record
Intervention acceptability
时间窗: end of week 6
Assessed via researcher-developed questionnaire
次要结局
- Lipid profile(6 weeks)
- C-Reactive Protein(6 weeks)
- Whole-body fat and fat free mass(6 weeks)
- Body circumferences(6 weeks)
- Menopausal symptom presence and severity(6 weeks)
- Systemic insulin resistance(6 weeks)
- Aortic stiffness (central to femoral)(6 weeks)
- Cardiorespiratory fitness(6 weeks)
- Dietary intake(6 weeks)
- Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)(6 weeks)
- Framingham 10-year risk (%)(6 weeks)
- Blood pressure(6 weeks)
- Brachial artery endothelial function(6 weeks)
- Depressive symptoms(6 weeks)
- Psychosocial stress(6 weeks)
- Health-related quality of life(6 weeks)
研究者
Amy Kirkham
Assistant Professor
University of Toronto