## Protocol Section
### Identification Module
**NCT ID:** NCT05709379

**Brief Title:** Effects of Interrupting Sedentary Behavior With High - or Low Intensity PA on CVD - and Cardiometabolic Riskfactors, and Cognitive Performance.

**Official Title:** Effects of Interrupting Sedentary Behavior With High - or Low Intensity Physical Activity on Cardiovascular - and Cardiometabolic Riskfactors, and Cognitive Performance.

#### Organization Study ID Info
**ID:** GENSED#2
#### Organization
**Class:** OTHER
**Full Name:** Norwegian School of Sport Sciences
### Status Module
#### Completion Date
**Date:** 2024-08-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-13

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2023-09-30

**Type:** ACTUAL

#### Start Date
**Date:** 2023-01-02

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2023-02-02
**Type:** ACTUAL
**Study First Submit Date:** 2023-01-06
**Study First Submit QC Date:** 2023-01-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** The Research Council of Norway

#### Lead Sponsor

**Class:** OTHER

**Name:** Norwegian School of Sport Sciences

#### Responsible Party

**Investigator Affiliation:** Norwegian School of Sport Sciences

**Investigator Full Name:** Jostein Steene-Johannessen

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The knowledge gap on sedentary behavior and sedentary breaks includes whether detrimental effects of sedentary behavior can be fully attenuated by 1.) sedentary breaks 2.) physical activity or 3.) both combined. Specifically, when breaking sedentary time which physical activity pattern- and intensity modifies the negative effects of sedentary behavior on glucose- and lipid metabolism? This lack of quantitative evidence calls for prospective experimental studies investigating the physiological and biological impacts of sedentary behavior, as well as the effectiveness of different strategies to reduce sedentary time. Thus, quantifying effects of the intensity, frequency, volume of sedentary breaks and/or physical activity on predefined outcomes is of importance.

Aims:

Our primary aims are to investigate the effects of breaking up sedentary time on glucose- and lipid metabolism and thus examine whether physical activity intensity breaks during sedentary breaks matter. Specifically, the aims of the PhD-project are to provide knowledge on the following questions:

• How does high- or low physical activity intensity sedentary breaks acutely influence glucose- and lipid metabolism under iso-caloric conditions?

**Detailed Description:** The participants will undergo 3 different trial conditions of which all are iso-caloric, but with different intensities when executing physical activity (PA) by treadmill walking corresponding to 25-30% or 80-85%, respectively, of their individual VO2max/peak values. PA intensities are estimated from the individual's pre-test. The trial-conditions are iso-caloric, and tailored to each individual's energy expenditure. This study has a is randomized cross-over design. If found eligible from step 1 and 2 in the inclusion process, participants will be invited to a final screening day in our lab. Eligible participants then consenting to joining the study will continue on to 3 trial days. Due to possible acute rise in insulin for up to 48 hours, a 5-14 day washout period between trials will be used to avoid carryover effects. In the washout periods between experimental conditions the participants will resume their habitual life activities and behaviors, i.e., diet and physical activity patterns. However, from visit 2, during washout the participants will wear accelerometers (ActiGraph GTX3+, Pensacola, FL) during waking hours to objectively measure sedentary time and physical activity for 7 consecutive days after each trial. Average sedentary time (hour/day) and time spent in , light-, moderate- and vigorous physical activity intensity (min/day) will be derived. During the main trial days, the participants may read or work on a personal computer during the sedentary time in the respective trial conditions. The sample size calculations with glucose as the primary outcome, are based on the study by Dunstan et al. (2012). They estimated that 19 paired observations were needed to secure a power of 0.90 in order to detect the smallest expected effect size between the interventions, when using a two-tailed test with a significance level of 5%. To account for the possibility of dropouts the sample size in the present project is set to recruit 30 participants, with 25 participants completing the trials, and thus planning for 80% power

### Conditions Module

**Conditions:**

- Sedentary Behavior

- Physical Activity

**Keywords:**

- Sedentary behavior

- Physical Activity

- Cardiometabolic

- Cardiovascular

- Sitting

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention Model Description:** This study will be conducted as randomized controlled crossover trials involving 3 different trial conditions in each of the studies. Randomization will be stratified based on sex. The order of trials will be assigned randomly by a third party using a computer software.

After pre-testing and familiarization (visit 1), the participants will undergo 3 different trial conditions of 7 hours. The trials are all iso-caloric, but with different intervals of sitting and executing moderate physical activity by treadmill walking/running corresponding to 25-30% or 80-85%, repectively of their individual VO2max values, estimated from the individual's pre-test. Blood samples will be taken and blood pressure measured every 30 minutes. The visits for main testing will be separated by a washout period of minimum 5 days, and women will be tested in the follicular phase.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 25

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Sitting from 8 am until 3pm.

**Intervention Names:**

- Behavioral: Sedentary behavior

**Label:** Control trial

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Physical activity on 80-85% of individual VO2max every hour. Modality: Hill walking/jogging on treadmill.

**Intervention Names:**

- Behavioral: Sedentary behavior

**Label:** High intensity sedentary breaks

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Physical activity on 25-30% of individual VO2max every hour. Modality: Hill walking on treadmill.

**Intervention Names:**

- Behavioral: Sedentary behavior

**Label:** Low intensity sedentary breaks

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control trial

- High intensity sedentary breaks

- Low intensity sedentary breaks

**Description:** Interrupting sitting with walking/jogging at either high -or low physical activity intensity.

**Name:** Sedentary behavior

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** During each of the trial conditions blood samples will be taken in the fasted state in the morning and then every 30 minutes of the trials (total 420minutes) through a peripheral venous catheter. We will then calculate the iAUC for glucose for each of the trial condition and compare the different trial conditions with the control condition

**Measure:** Total (tAUC)- and incremental areas under the curve (iAUC) for glucose

**Time Frame:** The iAUC for glucose will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)

#### Secondary Outcomes

**Description:** During each of the trial conditions blood samples will be taken in the fasted state in the morning and then every 30 minutes of the trials (total 420minutes) through a peripheral venous catheter. We will then calculate the iAUC for glucose for each of the trial condition and compare the different trial conditions with the control condition

**Measure:** tAUC and iAUC analyses for insulin

**Time Frame:** The iAUC for the secondary outcomes will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)

**Description:** During each of the trial conditions blood samples will be taken in the fasted state in the morning and then every 30 minutes of the trials (total 420minutes) through a peripheral venous catheter. We will then calculate the iAUC for glucose for each of the trial condition and compare the different trial conditions with the control condition

**Measure:** tAUC and iAUC analyses for c-peptide

**Time Frame:** The iAUC for the secondary outcomes will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)

**Description:** During each of the trial conditions blood samples will be taken in the fasted state in the morning and then every 30 minutes of the trials (total 420minutes) through a peripheral venous catheter. We will then calculate the iAUC for glucose for each of the trial condition and compare the different trial conditions with the control condition

**Measure:** tAUC and iAUC analyses for triglycerides

**Time Frame:** The iAUC for the secondary outcomes will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)

**Description:** During each of the trial conditions blood samples will be taken in the fasted state in the morning and then every 30 minutes of the trials (total 420minutes) through a peripheral venous catheter. We will then calculate the iAUC for glucose for each of the trial condition and compare the different trial conditions with the control condition

**Measure:** tAUC and iAUC analyses for lipids

**Time Frame:** The iAUC for the secondary outcomes will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)

**Description:** Cognitive function tasks will be performed, and cognitive function will be assessed by Trail making test A and B, and Stroop-test.

**Measure:** Cognitive function and performance

**Time Frame:** The cognitive measures will be performed during the procedure (at approx 400 minutes)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Inclusion Criteria:

* Predominantly sedentary occupation.
* Physical activity: equal or less tham 150 minutes /week
* Nonobese. Central adiposity: Waist circumference equal or less than 102 cm for men and equal or less than \< 88 cm for women. BMI \< 30 km·m2

Exclusion Criteria:

* Shift-work
* Smoking
* Pregnancy
* Current use of medication, except from hormonal contraceptives.
* No presence of any co-morbidity (e.g. diabetes type 2, cardiovascular or cardiorespiratory disease, or other conditions known to affect carbohydrate and lipid metabolism - thyroid-, -liver or kidney).
* Systolic /diastolic resting blood pressure: \> 140/90 mmHg
* Fasting blood glucose concentration: \> 6.1 mmol/L
* Abnormal total cholesterol, LDL, LDL or triglyceride concentrations (\> 50% above recommendations)

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Oslo

**Country:** Norway

**Facility:** Norwegian School of Sports Sciences

**Zip:** 0806

#### Overall Officials

**Official 1:**

**Affiliation:** Norwegian School of Sports Sciences

**Name:** Jostein Steene-Johennessen, Professor

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
