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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time-restricted eating and high-intensity interval training | Experimental | 12 months of periodised time-restricted eating and high-intensity interval training with digital follow-up |
|
| Control | No Intervention | No intervention or follow-up. Habitual lifestyle |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total fat mass | Change in total fat mass measured with bioelectrical impedance analysis | From baseline to after 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose | Fasting concentration of plasma glucose | From baseline to after 6 months and after 12 months |
| Total fat mass | Change in total fat mass measured with bioelectrical impedance analysis |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to high-intensity interval training | Number of completed exercise sessions out of those prescribed, in percentage | 12 months |
| Compliance to high-intensity interval training | Exercise intensity measured with pulse sensor. Heart rate percentage of individual heart rate maximum. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kamilla La Haganes, PhD | Contact | +4747316765 | kamilla.l.haganes@ntnu.no | |
| Trine Moholdt, PhD | Contact | +4797098594 | trine.moholdt@ntnu.no |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of circulation and medical imaging, NTNU | Recruiting | Trondheim | 7491 | Norway |
We will make de-identified individual participant data (IPD) collected in the study available to other researchers. We will upload a data set in an open access repository.
We will only share IPD that cannot be used to identify individuals.
The data will become available at the time of publication of the results from the study.
Open access
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|
| From baseline to after 6 months |
| Insulin | Fasting concentration of plasma insulin C-peptide | From baseline to after 6 months and after 12 months |
| Average glucose levels | Glycated haemoglobin (HbA1c) | From baseline to after 6 months and after 12 months |
| Blood cholesterol | Total fasting cholesterol in blood | From baseline to after 6 months and after 12 months |
| LDL-cholesterol | Fasting low-density lipoprotein-cholesterol in blood | From baseline to after 6 months and after 12 months |
| HDL-cholesterol | Fasting high-density lipoprotein-cholesterol in blood | From baseline to after 6 months and after 12 months |
| Triglycerides | Fasting triglycerides in blood | 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 | 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 | From baseline to after 6 months and after 12 months |
| Body mass | In kg, estimated with bioelectrical impedance analysis | From baseline to after 6 months and after 12 months |
| Fat-free mass | In kg, estimated with bioelectrical impedance analysis | From baseline to after 6 months and after 12 months |
| Visceral fat area | In cm2, estimated with bioelectrical impedance analysis | From baseline to after 6 months and after 12 months |
| Systolic blood pressure | Average of three measurements during rest in seated position, in mmHg | From baseline to after 6 months and after 12 months |
| Diastolic blood pressure | Average of three measurements during rest in seated position, in mmHg | 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 | From baseline to after 6 months and after 12 months |
| Physical activity levels | International Physical Activity Questionnaire | 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. | During baseline week, after 4, 13, 30, and 50 weeks. |
| Sleep quality | The Pittsburgh Sleep Quality Index questionnaire | From baseline to after 6 months and after 12 months |
| 12 months |
| Adherence to time-restricted eating | Average number of days per week a daily eating window of 10 hours or less was achieved | During baseline week, after 4, 13, 30, and 50 weeks. |
| Compliance to time-restricted eating | Average daily eating window, self-reported in hours/day | During baseline week, after 4, 13, 30, and 50 weeks. |
| Perception of intervention and digital follow-up | Qualitative interviews with selected participants to explore barriers and motivators | After 12 months |
| Sex differences | Sub-analyses of sex differences in the effectiveness of the intervention | From baseline to after 6 months and after 12 months |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D000093763 | Intermittent Fasting |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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