Frequent Activity Snacks Breaks
FABS
1 other identifier
interventional
20
1 country
1
Brief Summary
There is a growing health burden in Sweden and Europe arising from the interrelated sequelae of metabolic disorders comprising impaired glucose tolerance (IGT), obesity and T2DM. Obesity and inactivity are the main drivers of IGT and T2DM and are responsible for up to 8% of health costs and 13% of deaths in Europe, with the risk of co-morbidities rising in parallel with increasing body weight. IGT and T2DM are the paradigm of inactivity-related disorders: the majority of people who have IGT or T2DM are overweight and inactive, with up to 80% being obese. A recent meta-analysis of 42 studies concluded that sedentary time was independently associated with a greater risk of T2D, all-cause mortality, cardiovascular disease incidence and mortality, and cancer incidence and mortality (breast, colon, colorectal, endometrial and epithelial ovarian cancers) (Ann Intern Med. 2015;162:123-32). A recent systematic review of trials published up to April 2014 identified 16 separate studies and concluded that there is considerable evidence of the positive effects of breaking up prolonged sitting time with light-intensity ambulatory physical activity and standing on postprandial metabolic parameters, including glucose, insulin and triglyceride levels (Med Sci Sports Exerc. 2015:47:2053-61). However, to date, all of the published experimental trials describing the beneficial effects of breaking up sitting time on metabolic risk markers have been restricted to acute exposure periods (1-5 days). We will perform a RCT intervention study, which examines the efficacy (clinically relevant responses) and practical implementation of low-impact training in sedentary obese individuals during the day.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Feb 2017
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 3, 2017
CompletedFirst Posted
Study publicly available on registry
March 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2020
CompletedSeptember 2, 2020
September 1, 2020
2.5 years
March 3, 2017
September 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in metabolic health including insulin resistance
Oral glucose tolerance test including baseline glucose and insulin
Change from baseline and 4 week intervention
Secondary Outcomes (6)
Changes at the molecular level in skeletal and fat muscle biopsies
Change from baseline and 4 week intervention
Changes at the molecular level in skeletal and fat muscle biopsies
Change from baseline and 4 week intervention
Changes at the molecular level in skeletal and fat muscle biopsies
Change from baseline and 4 week intervention
Changes in gene expression
Change from baseline and 4 week intervention
Changes in physical activity
Change from baseline and 4 week intervention
- +1 more secondary outcomes
Study Arms (2)
No intervention
ACTIVE COMPARATORNormal lifestyle. Subjects will undergo a muscle and fat biopsy at the start of the 4 w period and after. An oral glucose test at the start and after completion of the 4 week period. Physical activity and glucose will be monitored during the study period.
Exercise intervention
EXPERIMENTALFollowed by a 1 week normal run in period subjects will undergo a 3 min bout, every half hour between 8 am and 6 pm comprises of simple low-intensity exercise such as moderate walking about or climbing a flight of stairs over a 3-week period. Subjects will undergo a muscle and fat biopsy at the start of the 4 w period and after. An oral glucose test at the start and after completion of the 4 week period. Physical activity and glucose will be monitored during the study period.
Interventions
Glucose concentrations during the study period
Objective measurements of standing and sitting time
Eligibility Criteria
You may qualify if:
- Sedentary lifestyle,
- BMI 30-40 kg/m2
You may not qualify if:
- Unable to read Swedish (for informed consent),
- anticoagulant therapy,
- unability to perform intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Baker Heart and Diabetes Institutecollaborator
- Australian Catholic Universitycollaborator
- Region Stockholmcollaborator
Study Sites (1)
Danderyd Hospital
Stockholm, 182 88, Sweden
Related Publications (1)
Smith JAB, Savikj M, Sethi P, Platt S, Gabriel BM, Hawley JA, Dunstan D, Krook A, Zierath JR, Naslund E. Three weeks of interrupting sitting lowers fasting glucose and glycemic variability, but not glucose tolerance, in free-living women and men with obesity. Am J Physiol Endocrinol Metab. 2021 Aug 1;321(2):E203-E216. doi: 10.1152/ajpendo.00599.2020. Epub 2021 Jun 21.
PMID: 34151582DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erik Naslund, MD, PhD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 3, 2017
First Posted
March 20, 2017
Study Start
February 1, 2017
Primary Completion
July 31, 2019
Study Completion
August 30, 2020
Last Updated
September 2, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share