Time-restricted Eating and Interval Training With Digital Follow-up

NCT ID: NCT05505305

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-05-13

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.

Conditions

Overweight and Obesity

Study Design

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

Study Groups

Time-restricted eating and high-intensity interval training

Seven weeks of time-restricted eating and high-intensity interval training with digital follow-up.

Group Type: EXPERIMENTAL

Time-restricted eating and high-intensity interval training

Intervention Type: BEHAVIORAL

Maximal daily eating window of 10 hours and high-intensity interval training (three weekly, unsupervised, aerobic exercise sessions performed at \> 90 % heart rate maximum). Each exercise session will last for 33-38 minutes. Participants will receive digital follow-up once weekly. The intervention period will be seven weeks,

Control

No intervention nor digital follow-up for seven weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Time-restricted eating and high-intensity interval training

Maximal daily eating window of 10 hours and high-intensity interval training (three weekly, unsupervised, aerobic exercise sessions performed at \> 90 % heart rate maximum). Each exercise session will last for 33-38 minutes. Participants will receive digital follow-up once weekly. The intervention period will be seven weeks,

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Øivind Rognmo, PhD

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology, Trondheim, Norway

Trine Moholdt, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology, Trondheim, Norway

Locations

Department of circulation and medical imaging, NTNU

Trondheim, , Norway

Countries

Norway

Other Identifiers

479143

Identifier Type: -

Identifier Source: org_study_id