Frequent Activity Snacks Breaks

NCT ID: NCT03083587

Last Updated: 2020-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2020-08-30

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.

Conditions

Obesity; Insulin Resistance; Sedentary Lifestyle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Normal lifestyle

Intervention Type: BEHAVIORAL

Normal lifestyle

muscle and fat biopsy

Intervention Type: PROCEDURE

Biopsy under local anesthesia

Continuous glucose monitoring

Intervention Type: DEVICE

Glucose concentrations during the study period

Activity monitoring (ActivePal)

Intervention Type: DEVICE

Objective measurements of standing and sitting time

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

Mild exercise 3 min every half hour

muscle and fat biopsy

Intervention Type: PROCEDURE

Biopsy under local anesthesia

Continuous glucose monitoring

Intervention Type: DEVICE

Glucose concentrations during the study period

Activity monitoring (ActivePal)

Intervention Type: DEVICE

Objective measurements of standing and sitting time

Interventions

Normal lifestyle

Normal lifestyle

Intervention Type: BEHAVIORAL

Exercise

Mild exercise 3 min every half hour

Intervention Type: BEHAVIORAL

muscle and fat biopsy

Biopsy under local anesthesia

Intervention Type: PROCEDURE

Continuous glucose monitoring

Glucose concentrations during the study period

Intervention Type: DEVICE

Activity monitoring (ActivePal)

Objective measurements of standing and sitting time

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baker Heart and Diabetes Institute

OTHER

Sponsor Role: collaborator

Australian Catholic University

OTHER

Sponsor Role: collaborator

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Erik Näslund

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erik Naslund, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Danderyd Hospital

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 34151582 (View on PubMed)

Other Identifiers

2016/1768

Identifier Type: -

Identifier Source: org_study_id