Frequent Activity Snacks Breaks

Obesity Clinical Trial

— FABS  

Official title:

Frequent Activity Snacks Breaks - Interrupting Sedentary Behaviour

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03083587
• Other study ID #: 2016/1768
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: August 30, 2020

Study information

• Verified date: September 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 30, 2020
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Sedentary lifestyle,

• BMI 30-40 kg/m2

Exclusion Criteria:

• Unable to read Swedish (for informed consent),

• anticoagulant therapy,

• unability to perform intervention

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity
• Sedentary Lifestyle

Intervention

Behavioral:
• Normal lifestyle
Normal lifestyle
• Exercise
Mild exercise 3 min every half hour

Procedure:
• muscle and fat biopsy
Biopsy under local anesthesia

Device:
• Continuous glucose monitoring
Glucose concentrations during the study period
• Activity monitoring (ActivePal)
Objective measurements of standing and sitting time

Locations

Country	Name	City	State
Sweden	Danderyd Hospital	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska Institutet	Australian Catholic University, Baker IDI Heart and Diabetes Institute, Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in metabolic health including insulin resistance	Oral glucose tolerance test including baseline glucose and insulin	Change from baseline and 4 week intervention
Secondary	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
Secondary	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
Secondary	Changes at the molecular level in skeletal and fat muscle biopsies	Lipid, protein and metabolites	Change from baseline and 4 week intervention
Secondary	Changes in gene expression	RNA, mRNA, DNA methylation	Change from baseline and 4 week intervention
Secondary	Changes in physical activity	Objective measures of standing and sitting	Change from baseline and 4 week intervention
Secondary	Changes in plasma glucose	Continuous glucose monitoring	Change from baseline and 4 week intervention