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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Time-restricted eating and high-intensity interval training
Behavioral1-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
Trial outcomes
Primary outcomes
Total fat mass
Change in total fat mass measured with bioelectrical impedance analysis
Secondary outcomes
Blood glucose
Fasting concentration of plasma glucose
Total fat mass
Change in total fat mass measured with bioelectrical impedance analysis
Insulin
Fasting concentration of plasma insulin C-peptide
Average glucose levels
Glycated haemoglobin (HbA1c)
Other outcomes
Adherence to high-intensity interval training
Number of completed exercise sessions out of those prescribed, in percentage
Compliance to high-intensity interval training
Exercise intensity measured with pulse sensor. Heart rate percentage of individual heart rate maximum.
Adherence to time-restricted eating
Average number of days per week a daily eating window of 10 hours or less was achieved
Compliance to time-restricted eating
Average daily eating window, self-reported in hours/day
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