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

Overweight and Obesity Clinical Trial

— TREHIIT-DFU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05505305
• Other study ID #: 479143
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: May 13, 2024

Study information

• Verified date: June 2024
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 13, 2024
• Est. primary completion date: May 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Time-restricted eating and high-intensity interval training
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,

Locations

Country	Name	City	State
Norway	Department of circulation and medical imaging, NTNU	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence to high-intensity interval training	Number of completed exercise sessions out of those prescribed, in percentage	Seven weeks
Other	Compliance to high-intensity interval training	Exercise intensity measured with pulse sensor. Heart rate percentage of individual heart rate maximum.	Seven weeks
Other	Adherence to time-restricted eating	Average number of days per week a daily eating window of 10 hours or less was achieved	Seven weeks
Other	Compliance to time-restricted eating	Average daily eating window, self-reported in hours/day	Seven weeks
Other	Perception of intervention and digital follow-up	Qualitative questionnaire after seven weeks of intervention	After seven weeks of intervention
Other	Sex differences	Sub-analyses of sex differences in the effectiveness of the intervention	From baseline to after 7 weeks of intervention
Primary	Total fat mass	Change in total fat mass measured with bioelectrical impedance analysis	From baseline to after 7 weeks of intervention
Secondary	Blood glucose	Fasting concentration of plasma glucose	From baseline to after 7 weeks of intervention
Secondary	Insulin	Fasting concentration of plasma insulin C-peptide	From baseline to after 7 weeks of intervention
Secondary	Average glucose levels	Glycated hemoglobin (HbA1c)	From baseline to after 7 weeks of intervention
Secondary	Blood Cholesterol	Total fasting cholesterol in blood	From baseline to after 7 weeks of intervention
Secondary	HDL-cholesterol in blood	Fasting high-density lipoprotein-cholesterol in blood	From baseline to after 7 weeks of intervention
Secondary	LDL-cholesterol in blood	Fasting low-density lipoprotein-cholesterol in blood	From baseline to after 7 weeks of intervention
Secondary	Triglycerides in blood	Fasting triglycerides in blood	From baseline to after 7 weeks of intervention
Secondary	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
Secondary	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
Secondary	Body mass	In kg, estimated with bioelectrical impedance analysis	From baseline to after 7 weeks of intervention
Secondary	Body fat-free mass	In kg, estimated with bioelectrical impedance analysis	From baseline to after 7 weeks of intervention
Secondary	Visceral fat area	In cm², estimated with bioelectrical impedance analysis	From baseline to after 7 weeks of intervention
Secondary	Systolic blood pressure	Average of three measurements during rest in seated position, in mmHg	From baseline to after 7 weeks of intervention
Secondary	Diastolic blood pressure	Average of three measurements during rest in seated position, in mmHg	From baseline to after 7 weeks of intervention
Secondary	Resting heart rate	Average of three measurements during rest in sitting position, in beats/min	From baseline to after 7 weeks of intervention
Secondary	Physical activity level	International Physical Activity Questionnaire, categorical score	From baseline to after 7 weeks of intervention
Secondary	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.
Secondary	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.
Secondary	Sleep quality	The Pittsburgh Sleep Quality Index questionnaire	From baseline to after 7 weeks of intervention
Secondary	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
Secondary	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