Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will investigate the effects of seven weeks of time-restricted eating combined with high-intensity interval training compared with a control group on body composition in adults with overweight/obesity. Participants in the intervention group will complete the intervention remotely and will receive weekly follow-up through online platforms (telephone, video call). Before and after the intervention, 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time-restricted eating and high-intensity interval training | Experimental | Seven weeks of time-restricted eating and high-intensity interval training with digital follow-up. |
|
| Control | No Intervention | No intervention nor digital follow-up for seven weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time-restricted eating and high-intensity interval training | Behavioral | Maximal daily eating window of 10 hours and high-intensity interval training (three weekly, unsupervised, aerobic exercise sessions performed at > 90 % heart rate maximum). Each exercise session will last for 33-38 minutes. Participants will receive digital follow-up once weekly. The intervention period will be seven weeks, |
| Measure | Description | Time Frame |
|---|---|---|
| Total fat mass | Change in total fat mass measured with bioelectrical impedance analysis | From baseline to after 7 weeks of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose | Fasting concentration of plasma glucose | From baseline to after 7 weeks of intervention |
| Insulin | Fasting concentration of plasma insulin C-peptide |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to high-intensity interval training | Number of completed exercise sessions out of those prescribed, in percentage | Seven weeks |
| Compliance to high-intensity interval training | Exercise intensity measured with pulse sensor. Heart rate percentage of individual heart rate maximum. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Øivind Rognmo, PhD | Norwegian University of Science and Technology | Study Director |
| Trine Moholdt, PhD | Norwegian University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of circulation and medical imaging, NTNU | Trondheim | 7491 | Norway |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| From baseline to after 7 weeks of intervention |
| Average glucose levels | Glycated hemoglobin (HbA1c) | From baseline to after 7 weeks of intervention |
| Blood Cholesterol | Total fasting cholesterol in blood | From baseline to after 7 weeks of intervention |
| HDL-cholesterol in blood | Fasting high-density lipoprotein-cholesterol in blood | From baseline to after 7 weeks of intervention |
| LDL-cholesterol in blood | Fasting low-density lipoprotein-cholesterol in blood | From baseline to after 7 weeks of intervention |
| Triglycerides in blood | Fasting triglycerides in blood | From baseline to after 7 weeks of intervention |
| Insulin sensitivity | Homeostatic model assessment for insulin resistance (HOMA-IR): 1.5 + fasting plasma glucose (mmol/L) × fasting plasma insulin C-peptide (pmol/L) / 2800 | From baseline to after 7 weeks of intervention |
| Cardiorespiratory fitness | Peak oxygen uptake at a maximum effort exercise test, measured in mL/min/kg and L/min | From baseline to after 7 weeks of intervention |
| Body mass | In kg, estimated with bioelectrical impedance analysis | From baseline to after 7 weeks of intervention |
| Body fat-free mass | In kg, estimated with bioelectrical impedance analysis | From baseline to after 7 weeks of intervention |
| Visceral fat area | In cm², estimated with bioelectrical impedance analysis | From baseline to after 7 weeks of intervention |
| Systolic blood pressure | Average of three measurements during rest in seated position, in mmHg | From baseline to after 7 weeks of intervention |
| Diastolic blood pressure | Average of three measurements during rest in seated position, in mmHg | From baseline to after 7 weeks of intervention |
| Resting heart rate | Average of three measurements during rest in sitting position, in beats/min | From baseline to after 7 weeks of intervention |
| Physical activity level | International Physical Activity Questionnaire, categorical score | From baseline to after 7 weeks of intervention |
| Self-reported physical activity | Self-reported duration and intensity of daily physical activity during baseline week, first week of intervention, and last week of intervention, in metabolic equivalent of task (MET)/week | 7 days at baseline, 7 days at start of intervention, 7 days at end of intervention. |
| Diet intake | Online food diary during baseline week, first week of intervention, and last week of intervention, in kilojoules (kJ)/week | 7 days at baseline, 7 days at start of intervention, 7 days at end of intervention. |
| Sleep quality | The Pittsburgh Sleep Quality Index questionnaire | From baseline to after 7 weeks of intervention |
| Sleep duration | Self-reported hours of sleep per night during baseline week, first week of intervention, and last week of intervention, average hours/night | 7 days at baseline, 7 days at start of intervention, 7 days at end of intervention |
| Appetite | Self-reported ratings of hunger/satiety on visual analogue scale upon waking and before bedtime during baseline week, first week of intervention, and last week of intervention, average hours/night | 7 days at baseline, 7 days at start of intervention, 7 days at end of intervention |
| Seven weeks |
| Adherence to time-restricted eating | Average number of days per week a daily eating window of 10 hours or less was achieved | Seven weeks |
| Compliance to time-restricted eating | Average daily eating window, self-reported in hours/day | Seven weeks |
| Perception of intervention and digital follow-up | Qualitative questionnaire after seven weeks of intervention | After seven weeks of intervention |
| Sex differences | Sub-analyses of sex differences in the effectiveness of the intervention | From baseline to after 7 weeks of intervention |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |