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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
Department of circulation and medical imaging, NTNU
Trondheim, Norway
RECRUITINGTotal fat mass
Change in total fat mass measured with bioelectrical impedance analysis
Time frame: From baseline to after 12 months
Blood glucose
Fasting concentration of plasma glucose
Time frame: From baseline to after 6 months and after 12 months
Total fat mass
Change in total fat mass measured with bioelectrical impedance analysis
Time frame: From baseline to after 6 months
Insulin
Fasting concentration of plasma insulin C-peptide
Time frame: From baseline to after 6 months and after 12 months
Average glucose levels
Glycated haemoglobin (HbA1c)
Time frame: From baseline to after 6 months and after 12 months
Blood cholesterol
Total fasting cholesterol in blood
Time frame: From baseline to after 6 months and after 12 months
LDL-cholesterol
Fasting low-density lipoprotein-cholesterol in blood
Time frame: From baseline to after 6 months and after 12 months
HDL-cholesterol
Fasting high-density lipoprotein-cholesterol in blood
Time frame: From baseline to after 6 months and after 12 months
Triglycerides
Fasting triglycerides in blood
Time frame: From baseline to after 6 months and after 12 months
Cardiorespiratory fitness
Peak oxygen uptake at a maximum effort test, measured in mL/min/kg and L/min
Time frame: From baseline to after 6 months and after 12 months
Insulin sensitivity
Homeostatic model assessment for insulin resistance (HOMA-IR): 1.5 + fasting plasma glucose (mmol/L) x fasting plasma insulin C-peptide (pmol/L)/2800
Time frame: From baseline to after 6 months and after 12 months
Body mass
In kg, estimated with bioelectrical impedance analysis
Time frame: From baseline to after 6 months and after 12 months
Fat-free mass
In kg, estimated with bioelectrical impedance analysis
Time frame: From baseline to after 6 months and after 12 months
Visceral fat area
In cm2, estimated with bioelectrical impedance analysis
Time frame: From baseline to after 6 months and after 12 months
Systolic blood pressure
Average of three measurements during rest in seated position, in mmHg
Time frame: From baseline to after 6 months and after 12 months
Diastolic blood pressure
Average of three measurements during rest in seated position, in mmHg
Time frame: From baseline to after 6 months and after 12 months
Resting heart rate
Average of three measurements during rest in sitting position, in beats/min
Time frame: From baseline to after 6 months and after 12 months
Physical activity levels
International Physical Activity Questionnaire
Time frame: From baseline to after 6 months and after 12 months
Diet intake
3-day diet diaries (two weekdays and one weekend day) with online diet diary.
Time frame: During baseline week, after 4, 13, 30, and 50 weeks.
Sleep quality
The Pittsburgh Sleep Quality Index questionnaire
Time frame: From baseline to after 6 months and after 12 months
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