Time-restricted Eating and High-intensity Interval Training for Metabolic Health in Adults With Overweight/Obesity (TREHIIT-3)

Norwegian University of Science and Technology

Status: Enrolling

Conditions: Overweight and Obesity

Treatments: Behavioral: Time-restricted eating and high-intensity interval training

Study type: Interventional

Funder types: Other

Identifiers

NCT07036562

911308

Details and patient eligibility

About

This study will investigate the effects of 12 months periodised time-restricted eating combined with high-intensity interval training compared with a control group on fat mass in adults with overweight/obesity. Participants in the intervention group will complete the intervention remotely and will receive follow-up by telephone. Before randomisation, after 6 months and after 12 months, 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Time-restricted eating and high-intensity interval training

Experimental group

Description:

12 months of periodised time-restricted eating and high-intensity interval training with digital follow-up

Treatment:

Behavioral: Time-restricted eating and high-intensity interval training

Control

No Intervention group

Description:

No intervention or follow-up. Habitual lifestyle