Time-restricted Eating and Interval Training With Digital Follow-up (TREHIIT-DFU)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: Time-restricted eating and high-intensity interval training

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kamilla La Haganes, PhD-cand.; Phone Number: +47 47316765; Email: kamilla.l.haganes@ntnu.no
• Study Contact Backup: Name: Trine Moholdt, PhD; Phone Number: +47 97098594; Email: trine.moholdt@ntnu.no

Study Locations

• Norway
  • Trondheim, Norway, 7491
    • Recruiting
    • Department of circulation and medical imaging, NTNU
    • Contact: Øivind Rognmo, PhD; Phone Number: +47 73598444; Email: oivind.rognmo@ntnu.no
    • Sub-Investigator: Kamilla La Haganes, PhD-cand.
    • Principal Investigator: Trine Moholdt, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Investigators: Study Director: Øivind Rognmo, PhD, Norwegian University of Science and Technology, Trondheim, Norway; Principal Investigator: Trine Moholdt, PhD, Norwegian University of Science and Technology, Trondheim, Norway

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: exercise; body composition; diet; time-restricted eating; high-intensity interval training
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: 479143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No