- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01997970
NEAT - Prevention and Treatment of Overweight and Obesity. (InphactUm)
Non-exercise Activity Thermogenesis (NEAT) - Prevention and Treatment of Overweight and Obesity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Umeå, Sweden
- Umea University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treadmill workstation
Will receive a health talk with recommendations about diet and physical activity habits and will also receive a treadmill workstation at regular office site for 12 months.
|
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.
Participants in both groups will receive a health talk with recommendations about diet and physical activity habits.
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Experimental: Control group
Will receive a health talk with recommendations about diet and physical activity habits.
Will continue to work with conventional office work at their regular desk.
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Participants in both groups will receive a health talk with recommendations about diet and physical activity habits.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in physical activity and sedentariness at 12 months
Time Frame: Baseline, 12 months
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Measured with an accelerometer (ActiGraph) and an inclinometer (ActivPAL).
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Baseline, 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in metabolism at 12 months
Time Frame: Baseline, 12 months
|
Metabolism: 2h glucose tolerance test.
lipids, Hb1Ac
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Baseline, 12 months
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Change from baseline in anthropometrics at 12 months
Time Frame: Baseline, 12 months
|
Length, height, weight, waist circumference, hip circumference, sagittal height, pulse, blood pressure.
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Baseline, 12 months
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Change from baseline in body composition at 12 months
Time Frame: Baseline, 12 months
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Measured with Dual X-Ray Absorptiometry (DXA)
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Baseline, 12 months
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Change from baseline in musculoskeletal pain at 12 months
Time Frame: Baseline, 12 months
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Measured with the Chronic Pain Grade Questionnaire
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Baseline, 12 months
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Change from baseline in stress at 12 months
Time Frame: Baseline, 12 months
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Measured by assessing cortisol levels in the saliva at 4 time points during one day.
Also measured with the stress- and energy scale.
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Baseline, 12 months
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Change from baseline in depression/anxiety at 12 months
Time Frame: Baseline, 12 months
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Measured with the Hospital Anxiety and Depression Scale.
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Baseline, 12 months
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Change from baseline in Quality of Life at 12 months
Time Frame: Baseline, 12 months
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Measured with 2 questions from the SF-36.
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Baseline, 12 months
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Change from baseline in cognitive Function and functional brain response at 12 months
Time Frame: Baseline, 12 months
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Measured with a cognitive test battery and functional MRI (fMRI).
Levels of Brain-Derived Neurotrophic Factor (BDNF) is measured in the plasma.
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Baseline, 12 months
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Qualitative interview study
Time Frame: 12 months
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Participants will be interviewed about experiences from being part of the study and about attitudes and factors that influences them to be physically active.
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tommy Olsson, Professor, Umea University
Publications and helpful links
General Publications
- Bergman F, Matsson-Frost T, Jonasson L, Chorell E, Sorlin A, Wennberg P, Ohberg F, Ryberg M, Levine JA, Olsson T, Boraxbekk CJ. Walking Time Is Associated With Hippocampal Volume in Overweight and Obese Office Workers. Front Hum Neurosci. 2020 Aug 20;14:307. doi: 10.3389/fnhum.2020.00307. eCollection 2020.
- Bergman F, Wahlstrom V, Stomby A, Otten J, Lanthen E, Renklint R, Waling M, Sorlin A, Boraxbekk CJ, Wennberg P, Ohberg F, Levine JA, Olsson T. Treadmill workstations in office workers who are overweight or obese: a randomised controlled trial. Lancet Public Health. 2018 Nov;3(11):e523-e535. doi: 10.1016/S2468-2667(18)30163-4. Epub 2018 Oct 12.
- Bergman F, Boraxbekk CJ, Wennberg P, Sorlin A, Olsson T. Increasing physical activity in office workers--the Inphact Treadmill study; a study protocol for a 13-month randomized controlled trial of treadmill workstations. BMC Public Health. 2015 Jul 10;15:632. doi: 10.1186/s12889-015-2017-6.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-338-31
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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