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| ID | Type | Description | Link |
|---|---|---|---|
| 285171 | Other Identifier | Comittee for Medical and Health Research Ethics Mid Norway |
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| Name | Class |
|---|---|
| Australian Catholic University | OTHER |
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This project will determine the independent and combined effects of high intensity interval training and time-restricted eating on blood sugar regulation among women in reproductive-age who have overweight or obesity. The intervention period will be seven weeks. Before and after the intervention, blood sugar regulation, body composition and physical fitness will be measured and compared between groups who are doing either high intensity interval training, time-restricted eating, both high intensity interval training and time-restricted eating, or who are in a control group. Physical activity, sleep quality, continuous glucose monitoring, adherence to the interventions and hunger/satiety will also be measured.
In a follow-up study, we will invite randomized participants to come in for new assessments of physical fitness, body composition and fasting blood samples, and they will be asked to complete questionnaires about adherence to the interventions two years after intervention-end. The first participants will come in to the laboratory for the two-year follow up in November 2021.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Intensity Interval Training | Experimental | High intensity interval training for seven weeks. Three weekly, supervised training sessions. |
|
| Time-Restricted Eating | Experimental | Time-restricted eating for seven weeks. Maximal daily eating window of 10 hours. |
|
| High Intensity Interval Training & Time-Restricted Eating | Experimental |
| |
| Control | No Intervention | Will be given information about the recommended level of physical activity for health benefits and a healthy diet. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Intensity Interval Training | Behavioral | Three weekly, supervised exercise sessions with high intensity. Each session will last for 30-45 minutes. Intervention period will be seven weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycaemic control | Total area under the plasma glucose curve over two hours after a 75 g oral glucose tolerance test | From baseline to after 7 weeks intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity | Insulin sensitivity estimated by homeostatic model assessment for insulin resistance (fasting serum insulin concentration (μU/mL) x fasting plasma glucose levels (mmol/L)/22.5) | From baseline to after 7 weeks intervention |
| Insulin levels after ingestion of glucose |
| 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, heart rate in percentage of individual heart rate maximum |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Øystein T Risa, PhD | Norwegian University of Science and Technology | Study Director |
| Trine T 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39861348 | Derived | Haganes KL, Devlin BL, Orr RK, Moholdt T. Impact of Time-Restricted Eating and High-Intensity Exercise on Nutrient Intake in Women with Overweight/Obesity: Secondary Analysis of a Randomized Controlled Trial. Nutrients. 2025 Jan 8;17(2):218. doi: 10.3390/nu17020218. | |
| 36198292 | Derived | Haganes KL, Silva CP, Eyjolfsdottir SK, Steen S, Grindberg M, Lydersen S, Hawley JA, Moholdt T. Time-restricted eating and exercise training improve HbA1c and body composition in women with overweight/obesity: A randomized controlled trial. Cell Metab. 2022 Oct 4;34(10):1457-1471.e4. doi: 10.1016/j.cmet.2022.09.003. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009043 | Motor Activity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
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Four-armed randomised controlled trial
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| Time-Restricted Eating | Behavioral | Restricted daily window of caloric intake to maximum 10 hours. Intervention period will be seven weeks. |
|
Total area under the serum insulin two hours after a 75 g oral glucose tolerance test |
| From baseline to after 7 weeks 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 intervention |
| Body mass | In kg | From baseline to after 7 weeks intervention |
| Body fat mass | In kg | From baseline to after 7 weeks intervention |
| Body fat percentage | In percent of total body mass | From baseline to after 7 weeks intervention |
| Fat-free body mass | In kg | From baseline to after 7 weeks intervention |
| Fat-free body mass percentage | In percent of total body mass | From baseline to after 7 weeks intervention |
| Systolic blood pressure | Average of three measurements, in mmHg | From baseline to after 7 weeks intervention |
| Diastolic blood pressure | Average of three measurements, in mmHg | From baseline to after 7 weeks intervention |
| Resting heart rate | Average of three measurements, in beats/min | From baseline to after 7 weeks intervention |
| Cholesterol in blood | Total fasting cholesterol in blood | From baseline to after 7 weeks intervention |
| High density lipoprotein cholesterol in blood | Fasting high density lipoprotein cholesterol i blood | From baseline to after 7 weeks intervention |
| Low density lipoprotein cholesterol in blood | Fasting low density lipoprotein cholesterol i blood | From baseline to after 7 weeks intervention |
| Triglycerides in blood | Fasting low density lipoprotein cholesterol i blood | From baseline to after 7 weeks intervention |
| Average glucose levels | Glycated haemoglobin (HbA1c) | From baseline to after 7 weeks intervention |
| Insulinemia | Fasting insulin in blood | From baseline to after 7 weeks intervention |
| 24 hour glycaemic control | Average interstitial glucose levels during 24 h, area under the curve | From baseline to the last 14 days of the intervention period |
| Postprandial glycaemic control | Average interstitial glucose levels 3 hours after the first meal of the day, area under the curve | From baseline to the last 14 days of the intervention period |
| Nocturnal glycaemic control | Average interstitial glucose levels from 23:00 h to 06:00 h | From baseline to the last 14 days of the intervention period |
| Self-reported physical activity | International Physical Activity Questionnaire | From baseline to after 7 weeks intervention |
| Measured physical activity | Measure by Sensewear activity monitor | From baseline to the last 14 days of the intervention period |
| Sleep | Self-reported: Pittsburgh Sleep Quality Index | From baseline to after 7 weeks intervention |
| Chronotype | Self-reported: Hornestberg Morningness Eveningness Questionnaire | From baseline to after 7 weeks intervention |
| Seven weeks |
| Compliance to time-restricted eating | Average daily eating window, in hours | Seven weeks |
| Adherence to time-restricted eating | Average number of days where per week that daily eating window is 10 hours or less. | Seven weeks |
| Diet intake at baseline | Online food diary | 14 days at baseline (one week of habitual diet and one week after the intervention starts) |
| Diet intake | Online food diary | The last 14 days of the intervention |
| 33550228 | Derived | Moholdt T, Silva CP, Lydersen S, Hawley JA. Isolated and combined effects of high-intensity interval training and time-restricted eating on glycaemic control in reproductive-aged women with overweight or obesity: study protocol for a four-armed randomised controlled trial. BMJ Open. 2021 Feb 5;11(2):e040020. doi: 10.1136/bmjopen-2020-040020. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |