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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorNorwegian University of Science and Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Body mass index ≥ 27 kg/m²

Able to walk or ride a bike > 60 min

Disqualifiers

On-going pregnancy

Lactation within 24 weeks of study commencement

High-intensity exercise ≥ 1/week

Habitual eating window ≤12 hours/day

Trial design

Design model

Parallel

Treatments tested in this trial

  • Time-restricted eating and high-intensity interval training

    Behavioral

    1-month intense periods of maximal daily eating window of 10 hours and high-intensity interval training (three weekly, unsupervised, aerobic exercise sessions performed at \> 90 % heart rate maximum), separated by 3-month maintenance periods of time-restricted eating on 5 days per week and minimum 1 HIIT session per week. Each exercise session will last for 33-38 minutes. Participants will receive digital follow-up once weekly during intense periods, and once monthly during maintenance periods. The intervention period will be 12 months in total.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Time-restricted eating and high-intensity interval trainingExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Total fat mass

Change in total fat mass measured with bioelectrical impedance analysis

Time frame
From baseline to after 12 months

Secondary outcomes

1

Blood glucose

Fasting concentration of plasma glucose

Time frame
From baseline to after 6 months and after 12 months
2

Total fat mass

Change in total fat mass measured with bioelectrical impedance analysis

Time frame
From baseline to after 6 months
3

Insulin

Fasting concentration of plasma insulin C-peptide

Time frame
From baseline to after 6 months and after 12 months
4

Average glucose levels

Glycated haemoglobin (HbA1c)

Time frame
From baseline to after 6 months and after 12 months

Other outcomes

1

Adherence to high-intensity interval training

Number of completed exercise sessions out of those prescribed, in percentage

Time frame
12 months
2

Compliance to high-intensity interval training

Exercise intensity measured with pulse sensor. Heart rate percentage of individual heart rate maximum.

Time frame
12 months
3

Adherence to time-restricted eating

Average number of days per week a daily eating window of 10 hours or less was achieved

Time frame
During baseline week, after 4, 13, 30, and 50 weeks.
4

Compliance to time-restricted eating

Average daily eating window, self-reported in hours/day

Time frame
During baseline week, after 4, 13, 30, and 50 weeks.

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