NEAT - Prevention and Treatment of Overweight and Obesity.

Obesity Clinical Trial

— InphactUm  

Official title:

Non-exercise Activity Thermogenesis (NEAT) - Prevention and Treatment of Overweight and Obesity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01997970
• Other study ID #: 2013-338-31
• Status: Active, not recruiting
• Phase: N/A
• First received: November 2, 2013
• Last updated: February 27, 2015
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2015
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

This study will investigate the effect on Non-exercise Activity Thermogenesis (NEAT) when implementing active workstation at offices compared to conventional office work. The primary hypothesis is that this implementation will lead to a significant increase in time spent walking per day.

Description:

NEAT consists of the energy expenditure of the physical activities that are non sporting-like and that we perform in our everyday life, such as walking, cleaning, shoveling snow etc. Which occupation we have play a big role in how much we are able to active our NEAT during our days and those who have more active jobs can expend up to 1500kcal more per day than those with sedentary jobs.

This study aims to try and increase NEAT at offices where sedentary time often is high. Participants will be randomized to either an intervention group or to a control group. Participants in the control group will continue to work at their regular desk, but will receive an individual health talk in the beginning of the study where diet and physical activity recommendations will be discussed.Participants in the intervention group will receive the same individual health talk and a treadmill desk, which they will use for 12 months at self-selected speed. They will be recommended to walk on the treadmill for at least 1 hour per day.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 67 Years

Eligibility

Inclusion Criteria:

• Office workers with mainly sedentary tasks

• BMI 25-40

Exclusion Criteria:

• Severe depression and/or anxiety

• Exhaustion disorder

• Diabetes Mellitus

• Severe cardiovascular disease

• Severe kidney disease

• Musculoskeletal disorders that prohibit walking on a treadmill

• Contraindications for physical activity

• Thyroidea illness

• Pregnancy

For fMRI-study, additional exclusion criteria are:

• Implanted metal- or electrical devices

• Pregnancy

• Extraneous metal pieces in the body

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Treadmill workstation
The intervention group will receive a treadmill workstation for 12 months. They will use this at self-selected speed and will be recommended to use this for at least 1 hour per day. Participants in the control group will continue with conventional office work at their regular desk. Participants in the intervention group will receive four boosting e-mails during the study period, in which they will be encouraged to use the treadmill.
• Health talk
Participants in both groups will receive a health talk with recommendations about diet and physical activity habits.

Locations

Country	Name	City	State
Sweden	Umeå University	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in physical activity and sedentariness at 12 months	Measured with an accelerometer (ActiGraph) and an inclinometer (ActivPAL).	Baseline, 12 months	No
Secondary	Change from baseline in metabolism at 12 months	Metabolism: 2h glucose tolerance test. lipids, Hb1Ac	Baseline, 12 months	No
Secondary	Change from baseline in anthropometrics at 12 months	Length, height, weight, waist circumference, hip circumference, sagittal height, pulse, blood pressure.	Baseline, 12 months	No
Secondary	Change from baseline in body composition at 12 months	Measured with Dual X-Ray Absorptiometry (DXA)	Baseline, 12 months	No
Secondary	Change from baseline in musculoskeletal pain at 12 months	Measured with the Chronic Pain Grade Questionnaire	Baseline, 12 months	No
Secondary	Change from baseline in stress at 12 months	Measured by assessing cortisol levels in the saliva at 4 time points during one day. Also measured with the stress- and energy scale.	Baseline, 12 months	No
Secondary	Change from baseline in depression/anxiety at 12 months	Measured with the Hospital Anxiety and Depression Scale.	Baseline, 12 months	No
Secondary	Change from baseline in Quality of Life at 12 months	Measured with 2 questions from the SF-36.	Baseline, 12 months	No
Secondary	Change from baseline in cognitive Function and functional brain response at 12 months	Measured with a cognitive test battery and functional MRI (fMRI). Levels of Brain-Derived Neurotrophic Factor (BDNF) is measured in the plasma.	Baseline, 12 months	No
Secondary	Qualitative interview study	Participants will be interviewed about experiences from being part of the study and about attitudes and factors that influences them to be physically active.	12 months	No