Time-restricted Eating and Interval Training With Digital Follow-up

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Time-restricted Eating and Interval Training With Digital Follow-up: A Randomized Controlled Trial

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: Time-restricted eating and high-intensity interval training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index ≥ 27 kg/m² Able to walk or ride a bike > 60 min Exclusion Criteria: On-going pregnancy Lactation within 24 weeks of study commencement High-intensity exercise ≥ 1/week Habitual eating window ≤12 hours/day Taking hypertension, glucose-, or lipid-lowering drugs Body mass variation ≥ 4 kg three months prior to study commencement Known diabetes mellitus (type 1 or 2) or cardiovascular disease Working night shifts

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Time-restricted eating and high-intensity interval training<br>Seven weeks of time-restricted eating and high-intensity interval training with digital follow-up. | Behavioral: Time-restricted eating and high-intensity interval training<br>* 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,<br>|
| No Intervention: Control<br>No intervention nor digital follow-up for seven weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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time-restricted eating, high-intensity interval training, exercise, diet, body composition