Time-restricted Eating and Interval Training With Digital Follow-up
- Conditions
- Overweight and Obesity
- Interventions
- Behavioral: Time-restricted eating and high-intensity interval training
- Registration Number
- NCT05505305
- Lead Sponsor
- Norwegian University of Science and Technology
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- Body mass index ≥ 27 kg/m²
- Able to walk or ride a bike > 60 min
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Time-restricted eating and high-intensity interval training Time-restricted eating and high-intensity interval training Seven weeks of time-restricted eating and high-intensity interval training with digital follow-up.
- Primary Outcome Measures
Name Time Method Total fat mass From baseline to after 7 weeks of intervention Change in total fat mass measured with bioelectrical impedance analysis
- Secondary Outcome Measures
Name Time Method Insulin From baseline to after 7 weeks of intervention Fasting concentration of plasma insulin C-peptide
Systolic blood pressure From baseline to after 7 weeks of intervention Average of three measurements during rest in seated position, in mmHg
Physical activity level From baseline to after 7 weeks of intervention International Physical Activity Questionnaire, categorical score
Average glucose levels From baseline to after 7 weeks of intervention Glycated hemoglobin (HbA1c)
Cardiorespiratory fitness From baseline to after 7 weeks of intervention Peak oxygen uptake at a maximum effort exercise test, measured in mL/min/kg and L/min
Visceral fat area From baseline to after 7 weeks of intervention In cm², estimated with bioelectrical impedance analysis
Sleep duration 7 days at baseline, 7 days at start of intervention, 7 days at end of intervention Self-reported hours of sleep per night during baseline week, first week of intervention, and last week of intervention, average hours/night
Blood glucose From baseline to after 7 weeks of intervention Fasting concentration of plasma glucose
Blood Cholesterol From baseline to after 7 weeks of intervention Total fasting cholesterol in blood
Insulin sensitivity From baseline to after 7 weeks of intervention Homeostatic model assessment for insulin resistance (HOMA-IR): 1.5 + fasting plasma glucose (mmol/L) × fasting plasma insulin C-peptide (pmol/L) / 2800
HDL-cholesterol in blood From baseline to after 7 weeks of intervention Fasting high-density lipoprotein-cholesterol in blood
Triglycerides in blood From baseline to after 7 weeks of intervention Fasting triglycerides in blood
Body mass From baseline to after 7 weeks of intervention In kg, estimated with bioelectrical impedance analysis
LDL-cholesterol in blood From baseline to after 7 weeks of intervention Fasting low-density lipoprotein-cholesterol in blood
Body fat-free mass From baseline to after 7 weeks of intervention In kg, estimated with bioelectrical impedance analysis
Diastolic blood pressure From baseline to after 7 weeks of intervention Average of three measurements during rest in seated position, in mmHg
Resting heart rate From baseline to after 7 weeks of intervention Average of three measurements during rest in sitting position, in beats/min
Appetite 7 days at baseline, 7 days at start of intervention, 7 days at end of intervention 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
Self-reported physical activity 7 days at baseline, 7 days at start of intervention, 7 days at end of intervention. 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
Diet intake 7 days at baseline, 7 days at start of intervention, 7 days at end of intervention. Online food diary during baseline week, first week of intervention, and last week of intervention, in kilojoules (kJ)/week
Sleep quality From baseline to after 7 weeks of intervention The Pittsburgh Sleep Quality Index questionnaire
Trial Locations
- Locations (1)
Department of circulation and medical imaging, NTNU
🇳🇴Trondheim, Norway