Frequent Activity Snacks Breaks (FABS)

Frequent Activity Snacks Breaks - Interrupting Sedentary Behaviour

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Sedentary Lifestyle; Insulin Resistance
• Intervention / Treatment: Behavioral: Normal lifestyle; Procedure: muscle and fat biopsy; Device: Continuous glucose monitoring; Device: Activity monitoring (ActivePal); Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 182 88
    • Danderyd Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Sedentary lifestyle,
• BMI 30-40 kg/m2

Exclusion Criteria:

• Unable to read Swedish (for informed consent),
• anticoagulant therapy,
• unability to perform intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: No intervention; Normal 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.	Behavioral: Normal lifestyle; Normal lifestyle; Procedure: muscle and fat biopsy; Biopsy under local anesthesia; Device: Continuous glucose monitoring; Glucose concentrations during the study period; Device: Activity monitoring (ActivePal); Objective measurements of standing and sitting time
Experimental: Exercise intervention; Followed 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.	Procedure: muscle and fat biopsy; Biopsy under local anesthesia; Device: Continuous glucose monitoring; Glucose concentrations during the study period; Device: Activity monitoring (ActivePal); Objective measurements of standing and sitting time; Behavioral: Exercise; Mild exercise 3 min every half hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in metabolic health including insulin resistance	Oral glucose tolerance test including baseline glucose and insulin	Change from baseline and 4 week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes at the molecular level in skeletal and fat muscle biopsies	insulin signalling cascade, the pathways that regulate protein synthesis and atrophy, as well as the content and function of mitochondria	Change from baseline and 4 week intervention
Changes at the molecular level in skeletal and fat muscle biopsies	The pathways that regulate protein synthesis and atrophy	Change from baseline and 4 week intervention
Changes at the molecular level in skeletal and fat muscle biopsies	Lipid, protein and metabolites	Change from baseline and 4 week intervention
Changes in gene expression	RNA, mRNA, DNA methylation	Change from baseline and 4 week intervention
Changes in physical activity	Objective measures of standing and sitting	Change from baseline and 4 week intervention
Changes in plasma glucose	Continuous glucose monitoring	Change from baseline and 4 week intervention

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm; Australian Catholic University; Baker Heart and Diabetes Institute
• Investigators: Principal Investigator: Erik Naslund, MD, PhD, Karolinska Institutet

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): August 30, 2020

Study Registration Dates

• First Submitted: March 3, 2017
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (Actual): March 20, 2017

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: 2016/1768

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No