Effects of Time-restricted Eating and Interval Training With Digital Follow-up: A Randomized Controlled Trial

Norwegian University of Science and Technology1 site in 1 country52 target enrollmentSeptember 1, 2022

ConditionsOverweight and Obesity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Overweight and Obesity
Sponsor: Norwegian University of Science and Technology
Enrollment: 52
Locations: 1
Primary Endpoint: Total fat mass
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will investigate the effects of seven weeks of time-restricted eating combined with high-intensity interval training compared with a control group on body composition in adults with overweight/obesity. Participants in the intervention group will complete the intervention remotely and will receive weekly follow-up through online platforms (telephone, video call). Before and after the intervention, the investigators will measure the participants' body composition, physical fitness, fasting blood glucose and insulin, blood lipids, and blood pressure. Physical activity, diet, sleep quality, appetite, and adherence to the intervention will also be measured. Secondary sub-analyses of sex differences in the responses to the intervention will be performed.

Registry

clinicaltrials.gov

Start Date

September 1, 2022

End Date

May 13, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Norwegian University of Science and Technology

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Body mass index ≥ 27 kg/m²
•Able to walk or ride a bike \> 60 min

Exclusion Criteria

•On-going pregnancy
•Lactation within 24 weeks of study commencement
•High-intensity exercise ≥ 1/week
•Habitual eating window ≤12 hours/day
•Taking hypertension, glucose-, or lipid-lowering drugs
•Body mass variation ≥ 4 kg three months prior to study commencement
•Known diabetes mellitus (type 1 or 2) or cardiovascular disease
•Working night shifts

Outcomes

Primary Outcomes

Total fat mass

Time Frame: From baseline to after 7 weeks of intervention

Change in total fat mass measured with bioelectrical impedance analysis

Secondary Outcomes

Insulin(From baseline to after 7 weeks of intervention)
Systolic blood pressure(From baseline to after 7 weeks of intervention)
Physical activity level(From baseline to after 7 weeks of intervention)
Average glucose levels(From baseline to after 7 weeks of intervention)
Blood Cholesterol(From baseline to after 7 weeks of intervention)
Cardiorespiratory fitness(From baseline to after 7 weeks of intervention)
Visceral fat area(From baseline to after 7 weeks of intervention)
Sleep duration(7 days at baseline, 7 days at start of intervention, 7 days at end of intervention)
Blood glucose(From baseline to after 7 weeks of intervention)
Insulin sensitivity(From baseline to after 7 weeks of intervention)
HDL-cholesterol in blood(From baseline to after 7 weeks of intervention)
Triglycerides in blood(From baseline to after 7 weeks of intervention)
Body mass(From baseline to after 7 weeks of intervention)
LDL-cholesterol in blood(From baseline to after 7 weeks of intervention)
Body fat-free mass(From baseline to after 7 weeks of intervention)
Diastolic blood pressure(From baseline to after 7 weeks of intervention)
Resting heart rate(From baseline to after 7 weeks of intervention)
Appetite(7 days at baseline, 7 days at start of intervention, 7 days at end of intervention)
Sleep quality(From baseline to after 7 weeks of intervention)
Self-reported physical activity(7 days at baseline, 7 days at start of intervention, 7 days at end of intervention.)
Diet intake(7 days at baseline, 7 days at start of intervention, 7 days at end of intervention.)