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

June 19, 2024 updated by: Norwegian University of Science and Technology

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Norway
      • Trondheim, Norway, 7491
        • Department of circulation and medical imaging, NTNU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total fat mass
Time Frame: From baseline to after 7 weeks of intervention
Change in total fat mass measured with bioelectrical impedance analysis
From baseline to after 7 weeks of intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood glucose
Time Frame: From baseline to after 7 weeks of intervention
Fasting concentration of plasma glucose
From baseline to after 7 weeks of intervention
Insulin
Time Frame: From baseline to after 7 weeks of intervention
Fasting concentration of plasma insulin C-peptide
From baseline to after 7 weeks of intervention
Average glucose levels
Time Frame: From baseline to after 7 weeks of intervention
Glycated hemoglobin (HbA1c)
From baseline to after 7 weeks of intervention
Blood Cholesterol
Time Frame: From baseline to after 7 weeks of intervention
Total fasting cholesterol in blood
From baseline to after 7 weeks of intervention
HDL-cholesterol in blood
Time Frame: From baseline to after 7 weeks of intervention
Fasting high-density lipoprotein-cholesterol in blood
From baseline to after 7 weeks of intervention
LDL-cholesterol in blood
Time Frame: From baseline to after 7 weeks of intervention
Fasting low-density lipoprotein-cholesterol in blood
From baseline to after 7 weeks of intervention
Triglycerides in blood
Time Frame: From baseline to after 7 weeks of intervention
Fasting triglycerides in blood
From baseline to after 7 weeks of intervention
Insulin sensitivity
Time Frame: 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
From baseline to after 7 weeks of intervention
Cardiorespiratory fitness
Time Frame: 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
From baseline to after 7 weeks of intervention
Body mass
Time Frame: From baseline to after 7 weeks of intervention
In kg, estimated with bioelectrical impedance analysis
From baseline to after 7 weeks of intervention
Body fat-free mass
Time Frame: From baseline to after 7 weeks of intervention
In kg, estimated with bioelectrical impedance analysis
From baseline to after 7 weeks of intervention
Visceral fat area
Time Frame: From baseline to after 7 weeks of intervention
In cm², estimated with bioelectrical impedance analysis
From baseline to after 7 weeks of intervention
Systolic blood pressure
Time Frame: From baseline to after 7 weeks of intervention
Average of three measurements during rest in seated position, in mmHg
From baseline to after 7 weeks of intervention
Diastolic blood pressure
Time Frame: From baseline to after 7 weeks of intervention
Average of three measurements during rest in seated position, in mmHg
From baseline to after 7 weeks of intervention
Resting heart rate
Time Frame: From baseline to after 7 weeks of intervention
Average of three measurements during rest in sitting position, in beats/min
From baseline to after 7 weeks of intervention
Physical activity level
Time Frame: From baseline to after 7 weeks of intervention
International Physical Activity Questionnaire, categorical score
From baseline to after 7 weeks of intervention
Self-reported physical activity
Time Frame: 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
7 days at baseline, 7 days at start of intervention, 7 days at end of intervention.
Diet intake
Time Frame: 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
7 days at baseline, 7 days at start of intervention, 7 days at end of intervention.
Sleep quality
Time Frame: From baseline to after 7 weeks of intervention
The Pittsburgh Sleep Quality Index questionnaire
From baseline to after 7 weeks of intervention
Sleep duration
Time Frame: 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
7 days at baseline, 7 days at start of intervention, 7 days at end of intervention
Appetite
Time Frame: 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
7 days at baseline, 7 days at start of intervention, 7 days at end of intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adherence to high-intensity interval training
Time Frame: Seven weeks
Number of completed exercise sessions out of those prescribed, in percentage
Seven weeks
Compliance to high-intensity interval training
Time Frame: Seven weeks
Exercise intensity measured with pulse sensor. Heart rate percentage of individual heart rate maximum.
Seven weeks
Adherence to time-restricted eating
Time Frame: Seven weeks
Average number of days per week a daily eating window of 10 hours or less was achieved
Seven weeks
Compliance to time-restricted eating
Time Frame: Seven weeks
Average daily eating window, self-reported in hours/day
Seven weeks
Perception of intervention and digital follow-up
Time Frame: After seven weeks of intervention
Qualitative questionnaire after seven weeks of intervention
After seven weeks of intervention
Sex differences
Time Frame: From baseline to after 7 weeks of intervention
Sub-analyses of sex differences in the effectiveness of the intervention
From baseline to after 7 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Norwegian University of Science and Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 13, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 13, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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