Multiple Risk Factor Intervention Trial

NCT05758857 | Completed

• 1 other identifier: 43521
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Disturbance; Sedentary Behavior

Keywords

primary prevention

Outcome Measures

Primary Outcomes (3)

• Physical activity intervention feasibility

  Determined as an average adherence to physical activity guidelines of ≥100% measured via Garmin smartwatch

  end of week 6

• Diet quality intervention feasibility

  Determined as a 5-point improvement in diet quality measured via healthy eating index from 3-day diet record

  end of week 6

• Intervention acceptability

  Assessed via researcher-developed questionnaire

  end of week 6

Secondary Outcomes (16)

• Systemic insulin resistance

  6 weeks

• Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

  6 weeks

• Framingham 10-year risk (%)

  6 weeks

• Lipid profile

  6 weeks

• C-Reactive Protein

  6 weeks

Other Outcomes (12)

• Health-related quality of life

  6 months

• Psychosocial stress

  6 months

• Intervention acceptability

  6 months

Study Arms (3)

Guidelines-based physical activity

EXPERIMENTAL

150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening

Behavioral: Experimental: Guidelines-based physical activity

Guidelines-based physical activity and healthy eating

EXPERIMENTAL

150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening + counselling to follow Canada's Food Guide

Behavioral: Experimental: Guidelines-based physical activity; Behavioral: Experimental: Guidelines-based healthy eating

Stretching exercise

PLACEBO COMPARATOR

Whole-body stretching

Behavioral: Stretching exercise

Interventions

Experimental: Guidelines-based physical activity BEHAVIORAL

Through a combination of exercise trainer-led in-person and virtual sessions, as well as counselling for independent aerobic exercise, participants will be guided to achieve 150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening.

Guidelines-based physical activity; Guidelines-based physical activity and healthy eating

Experimental: Guidelines-based healthy eating BEHAVIORAL

One-on-one phone/virtual counselling from a registered dietitian to change dietary habits to be in line with Canada's Food Guide.

Guidelines-based physical activity and healthy eating

Stretching exercise BEHAVIORAL

Twice weekly virtual instructor-led whole-body stretching class.

Stretching exercise

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead
• Women's College Hospital: collaborator

Study Sites (1)

Goldring Centre for High Performance Sport

Toronto, Ontario, M5S 2C9, Canada

Location

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 3-arm parallel-group randomized controlled trial

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: March 8, 2023
• Study Start: November 6, 2022
• Primary Completion: June 28, 2023
• Study Completion: June 28, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)