Combining Physical Activity and Sedentary Interventions to Improve Cardiometabolic Health

NCT07363499 | Active Not Recruiting

• 1 other identifier: CME2024/069
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Many adults spend a large part of their day sitting, especially at work. Long periods of sitting and not moving enough can increase the risk of health problems such as heart disease and type 2 diabetes. This risk is even higher in people who have early warning signs like being overweight, having high blood pressure, or problems with blood sugar. Together, these problems are called metabolic syndrome. The goal of this study is to find out whether combining regular exercise with reducing sitting time during the day can improve heart and metabolic health more than exercise alone. About 40 adults between 18 and 65 years old who work mainly at a desk and sit for more than 9 hours a day will take part. All participants will first continue their normal daily routine for two weeks. After that, they will be randomly placed into one of two groups for eight weeks: Exercise group: Participants will follow the World Health Organization guidelines for physical activity. This includes two sessions of moderate exercise each week (such as brisk walking or cycling) and one session of more intense exercise each week. Exercise plus less sitting group: Participants will do the same exercise program, but they will also be encouraged to sit less during the workday. They will be asked to stand more, use sit-stand desks if possible, and avoid sitting for longer than one hour at a time. Participants will visit the research center three times for health tests. These tests include blood samples to look at blood sugar, insulin, and fats in the blood, measurements of blood pressure and heart function, body composition scans, fitness tests, and questionnaires about sleep, diet, and quality of life. They will also wear activity monitors to measure how much they sit, stand, and move. The main outcome is how the body handles sugar (insulin sensitivity). The researchers hope to learn whether sitting less, in addition to exercising, leads to better improvements in heart and metabolic health. The results may help develop better lifestyle advice to prevent heart disease and diabetes in people with desk jobs.

Conditions

Cardiometabolic Risk Factors; Sedentary Behaviors; Insulin Resistance

Keywords

Cardiometabolic health; Sedentary behaviour; Physical activity; Exercise; Insulin resistance

Outcome Measures

Primary Outcomes (4)

• Homeostatic model assessment for insulin resistance (HOMA-IR)

  The HOMA-IR is calculated from the fasting insulin and glucose concentration.

  From enrollment to the end of the intervention at 8 weeks.

• Whole-body insulin sensitivity index (ISI)

  An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity using the whole-body insulin sensitivity index (ISI). The ISI is calculated from both insulin and glucose concentrations.

  From enrollment to the end of the intervention at 8 weeks

• Area under the curve of insulin concentrations

  An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity by calculation of the area under the curve of insulin concentrations.

  From enrollment to the end of the intervention at 8 weeks

• Insulinogenic index

  An oral glucose tolerance test will be performed for assessment of beta cell function by calculation of the insulinogenic index. The insulinogenic index is calculated from both insulin and glucose concentrations.

  From enrollment to the end of the intervention at 8 weeks.

Secondary Outcomes (28)

• Body composition

  From enrollment to the end of the intervention at 8 weeks.

• Cardiorespiratory Fitness

  From enrollment to the end of the intervention at 8 weeks.

• Area under the curve of glucose concentrations

  From enrollment to the end of the intervention at 8 weeks

• Steps per day

  From enrollment to the end of the intervention at 8 weeks. For one week during the first four weeks of the intervention. For one week during the last four weeks of the intervention.

• Sitting time

  From enrollment to the end of the intervention at 8 weeks. For one week during the first four weeks of the intervention. For one week during the last four weeks of the intervention.

Study Arms (3)

Control arm (2 weeks)

NO INTERVENTION

All participants will follow a two-week period where no intervention is administered.

PA group (8 weeks)

ACTIVE COMPARATOR

After the control period without intervention, one halve of the participants is randomised to the PA group where participants are encouraged to adhere to WHO physical activity guidelines during 8 weeks.

Behavioral: WHO physical activity guideline

PA-SB group (8 weeks)

EXPERIMENTAL

After the control period without intervention, one halve of the participants is randomised to the PA-SB group where participants are encouraged to adhere to WHO physical activity guidelines. In addition, sedentary time at the workplace is reduced. The duration of this intervention is 8 weeks.

Behavioral: WHO physical activity guideline; Behavioral: Sedentary behaviour reduction at the workplace

Interventions

WHO physical activity guideline BEHAVIORAL

Individualised Physical Activity Plan (8 weeks): • Two weekly sessions of moderate-intensity physical activity (MIPA): Frequency: 2 sessions per week. Unsupervised. Duration: Initially 40 minutes per session, increasing to 50 minutes by week 4. Type of Activity: Participants can select from brisk walking, cycling, swimming, or elliptical training. Intensity: 40-60% of maximal oxygen consumption, monitored with wearable heart rate devices. • One weekly session of vigorous-intensity physical activity (VIPA): Frequency: 1 session per week. Supervised or predetermined. Duration: Initially 20 minutes per session, increasing to 30 minutes by week 4. Type of Activity: Options include running, high-intensity interval training (HIIT), or fast cycling. Intensity: 60-90% of maximal oxygen consumption, tracked with heart rate devices. • Weekly check-ins will allow adjustments based on individual feedback and progress.

PA group (8 weeks); PA-SB group (8 weeks)

Sedentary behaviour reduction at the workplace BEHAVIORAL

Participants will be encouraged to replace seated work with standing work and engage in light physical activity breaks. • Workplace Integration Strategies: Participants working in an office setting will be provided with adjustable sit-stand desks where possible. • Active Breaks and Movement Interventions: Participants will be prompted to take short (2min) active breaks after prolonged periods of sedentary behaviour. Break activities will include standing, stretching, or light movement such as walking.

PA-SB group (8 weeks)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 65 years
• Profession where most of the time is spent sitting.
• Not regularly physically active (\>3 trainings per week in the last three months)
• Sedentary (on average \>9 hours per day spent sedentary on a working day)
• Written informed consent to participate in the study.

You may not qualify if:

• Pregnancy.
• Consumption of more than 20 units of alcohol per week.
• Medical conditions that limit physical activity.
• Specific diet (e.g. low-carbohydrate or calorie-restricted).
• Unstable body weight in the past month.
• Participation in another study that could potentially affect your blood parameters in the past month.

Sponsors & Collaborators

• Hasselt University: lead

Study Sites (1)

Univeristeit Hasselt

Diepenbeek, Limburg, 3590, Belgium

Location

MeSH Terms

Conditions

Sedentary Behavior; Insulin Resistance; Motor Activity

Condition Hierarchy (Ancestors)

Behavior; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jen Vanherle, MSc

  Hasselt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr. Bert Op 't Eijnde

Model Details: First all participants will follow a control period after which they are randomised to a parallel design with two intervention groups.

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 23, 2026
• Study Start: April 28, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication of the results, data will become available for a duration of 25 years.
• Access Criteria: Access will be granted after motivated and reasonable request to the principal investigator.

Locations

BE (1)