Clinical trial NCT05758857: Multiple Risk Factor Intervention Trial
Official title: Multiple Risk Factor Intervention Trial: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Disturbance
Sedentary Behavior
Keywords: primary prevention
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Women's College Hospital
First posted: 2023-03-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3-arm parallel-group randomized controlled trial
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* females
* pre- or postmenopausal
* aged 30+ years
* moderate or high Canadian Diabetes Risk Score score

Exclusion Criteria:

* 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

Primary outcomes:
measure: Physical activity intervention feasibility
timeFrame: end of week 6
measure: Diet quality intervention feasibility
timeFrame: end of week 6
measure: Intervention acceptability
timeFrame: end of week 6
Secondary outcomes:
measure: Systemic insulin resistance
timeFrame: 6 weeks
measure: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
timeFrame: 6 weeks
measure: Framingham 10-year risk (%)
timeFrame: 6 weeks
measure: Lipid profile
timeFrame: 6 weeks
measure: C-Reactive Protein
timeFrame: 6 weeks
measure: Blood pressure
timeFrame: 6 weeks
measure: Aortic stiffness (central to femoral)
timeFrame: 6 weeks
measure: Brachial artery endothelial function
timeFrame: 6 weeks
measure: Cardiorespiratory fitness
timeFrame: 6 weeks
measure: Whole-body fat and fat free mass
timeFrame: 6 weeks
measure: Body circumferences
timeFrame: 6 weeks
measure: Depressive symptoms
timeFrame: 6 weeks
measure: Dietary intake
timeFrame: 6 weeks
measure: Menopausal symptom presence and severity
timeFrame: 6 weeks
measure: Health-related quality of life
timeFrame: 6 weeks
measure: Psychosocial stress
timeFrame: 6 weeks
Other outcomes:
measure: Health-related quality of life
timeFrame: 6 months
measure: Psychosocial stress
timeFrame: 6 months
measure: Intervention acceptability
timeFrame: 6 months
measure: Menopausal symptom presence and severity
timeFrame: 6 months
measure: Dietary intake
timeFrame: 6 months
measure: Depressive symptoms
timeFrame: 6 months
measure: Body circumferences
timeFrame: 6 months
measure: Whole-body fat and fat free mass
timeFrame: 6 months
measure: Cardiorespiratory fitness
timeFrame: 6 months
measure: Blood pressure
timeFrame: 6 months
measure: Physical activity intervention feasibility
timeFrame: 6 months
measure: Diet quality intervention feasibility
timeFrame: 6 months
Locations:
city: Toronto
country: Canada
facility: Goldring Centre for High Performance Sport
state: Ontario
Study officials:
References: