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

Primary Purpose

Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Time-restricted eating and high-intensity interval training
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring time-restricted eating, high-intensity interval training, exercise, diet, body composition

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of circulation and medical imaging, NTNURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Time-restricted eating and high-intensity interval training

Control

Arm Description

Seven weeks of time-restricted eating and high-intensity interval training with digital follow-up.

No intervention nor digital follow-up for seven weeks.

Outcomes

Primary Outcome Measures

Total fat mass
Change in total fat mass measured with bioelectrical impedance analysis

Secondary Outcome Measures

Blood glucose
Fasting concentration of plasma glucose
Insulin
Fasting concentration of plasma insulin C-peptide
Average glucose levels
Glycated hemoglobin (HbA1c)
Blood Cholesterol
Total fasting cholesterol in blood
HDL-cholesterol in blood
Fasting high-density lipoprotein-cholesterol in blood
LDL-cholesterol in blood
Fasting low-density lipoprotein-cholesterol in blood
Triglycerides in blood
Fasting triglycerides in blood
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
Cardiorespiratory fitness
Peak oxygen uptake at a maximum effort exercise test, measured in mL/min/kg and L/min
Body mass
In kg, estimated with bioelectrical impedance analysis
Body fat-free mass
In kg, estimated with bioelectrical impedance analysis
Visceral fat area
In cm², estimated with bioelectrical impedance analysis
Systolic blood pressure
Average of three measurements during rest in seated position, in mmHg
Diastolic blood pressure
Average of three measurements during rest in seated position, in mmHg
Resting heart rate
Average of three measurements during rest in sitting position, in beats/min
Physical activity level
International Physical Activity Questionnaire, categorical score
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
Diet intake
Online food diary during baseline week, first week of intervention, and last week of intervention, in kilojoules (kJ)/week
Sleep quality
The Pittsburgh Sleep Quality Index questionnaire
Sleep duration
Self-reported hours of sleep per night during baseline week, first week of intervention, and last week of intervention, average hours/night
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

Full Information

First Posted
August 16, 2022
Last Updated
June 5, 2023
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05505305
Brief Title
Time-restricted Eating and Interval Training With Digital Follow-up
Acronym
TREHIIT-DFU
Official Title
Effects of Time-restricted Eating and Interval Training With Digital Follow-up: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
time-restricted eating, high-intensity interval training, exercise, diet, body composition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Time-restricted eating and high-intensity interval training
Arm Type
Experimental
Arm Description
Seven weeks of time-restricted eating and high-intensity interval training with digital follow-up.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention nor digital follow-up for seven weeks.
Intervention Type
Behavioral
Intervention Name(s)
Time-restricted eating and high-intensity interval training
Intervention Description
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,
Primary Outcome Measure Information:
Title
Total fat mass
Description
Change in total fat mass measured with bioelectrical impedance analysis
Time Frame
From baseline to after 7 weeks of intervention
Secondary Outcome Measure Information:
Title
Blood glucose
Description
Fasting concentration of plasma glucose
Time Frame
From baseline to after 7 weeks of intervention
Title
Insulin
Description
Fasting concentration of plasma insulin C-peptide
Time Frame
From baseline to after 7 weeks of intervention
Title
Average glucose levels
Description
Glycated hemoglobin (HbA1c)
Time Frame
From baseline to after 7 weeks of intervention
Title
Blood Cholesterol
Description
Total fasting cholesterol in blood
Time Frame
From baseline to after 7 weeks of intervention
Title
HDL-cholesterol in blood
Description
Fasting high-density lipoprotein-cholesterol in blood
Time Frame
From baseline to after 7 weeks of intervention
Title
LDL-cholesterol in blood
Description
Fasting low-density lipoprotein-cholesterol in blood
Time Frame
From baseline to after 7 weeks of intervention
Title
Triglycerides in blood
Description
Fasting triglycerides in blood
Time Frame
From baseline to after 7 weeks of intervention
Title
Insulin sensitivity
Description
Homeostatic model assessment for insulin resistance (HOMA-IR): 1.5 + fasting plasma glucose (mmol/L) × fasting plasma insulin C-peptide (pmol/L) / 2800
Time Frame
From baseline to after 7 weeks of intervention
Title
Cardiorespiratory fitness
Description
Peak oxygen uptake at a maximum effort exercise test, measured in mL/min/kg and L/min
Time Frame
From baseline to after 7 weeks of intervention
Title
Body mass
Description
In kg, estimated with bioelectrical impedance analysis
Time Frame
From baseline to after 7 weeks of intervention
Title
Body fat-free mass
Description
In kg, estimated with bioelectrical impedance analysis
Time Frame
From baseline to after 7 weeks of intervention
Title
Visceral fat area
Description
In cm², estimated with bioelectrical impedance analysis
Time Frame
From baseline to after 7 weeks of intervention
Title
Systolic blood pressure
Description
Average of three measurements during rest in seated position, in mmHg
Time Frame
From baseline to after 7 weeks of intervention
Title
Diastolic blood pressure
Description
Average of three measurements during rest in seated position, in mmHg
Time Frame
From baseline to after 7 weeks of intervention
Title
Resting heart rate
Description
Average of three measurements during rest in sitting position, in beats/min
Time Frame
From baseline to after 7 weeks of intervention
Title
Physical activity level
Description
International Physical Activity Questionnaire, categorical score
Time Frame
From baseline to after 7 weeks of intervention
Title
Self-reported physical activity
Description
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
Time Frame
7 days at baseline, 7 days at start of intervention, 7 days at end of intervention.
Title
Diet intake
Description
Online food diary during baseline week, first week of intervention, and last week of intervention, in kilojoules (kJ)/week
Time Frame
7 days at baseline, 7 days at start of intervention, 7 days at end of intervention.
Title
Sleep quality
Description
The Pittsburgh Sleep Quality Index questionnaire
Time Frame
From baseline to after 7 weeks of intervention
Title
Sleep duration
Description
Self-reported hours of sleep per night during baseline week, first week of intervention, and last week of intervention, average hours/night
Time Frame
7 days at baseline, 7 days at start of intervention, 7 days at end of intervention
Title
Appetite
Description
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
Time Frame
7 days at baseline, 7 days at start of intervention, 7 days at end of intervention
Other Pre-specified Outcome Measures:
Title
Adherence to high-intensity interval training
Description
Number of completed exercise sessions out of those prescribed, in percentage
Time Frame
Seven weeks
Title
Compliance to high-intensity interval training
Description
Exercise intensity measured with pulse sensor. Heart rate percentage of individual heart rate maximum.
Time Frame
Seven weeks
Title
Adherence to time-restricted eating
Description
Average number of days per week a daily eating window of 10 hours or less was achieved
Time Frame
Seven weeks
Title
Compliance to time-restricted eating
Description
Average daily eating window, self-reported in hours/day
Time Frame
Seven weeks
Title
Perception of intervention and digital follow-up
Description
Qualitative questionnaire after seven weeks of intervention
Time Frame
After seven weeks of intervention
Title
Sex differences
Description
Sub-analyses of sex differences in the effectiveness of the intervention
Time Frame
From baseline to after 7 weeks of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kamilla La Haganes, PhD-cand.
Phone
+47 47316765
Email
kamilla.l.haganes@ntnu.no
First Name & Middle Initial & Last Name or Official Title & Degree
Trine Moholdt, PhD
Phone
+47 97098594
Email
trine.moholdt@ntnu.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Øivind Rognmo, PhD
Organizational Affiliation
Norwegian University of Science and Technology, Trondheim, Norway
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Trine Moholdt, PhD
Organizational Affiliation
Norwegian University of Science and Technology, Trondheim, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of circulation and medical imaging, NTNU
City
Trondheim
ZIP/Postal Code
7491
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Øivind Rognmo, PhD
Phone
+47 73598444
Email
oivind.rognmo@ntnu.no
First Name & Middle Initial & Last Name & Degree
Kamilla La Haganes, PhD-cand.
First Name & Middle Initial & Last Name & Degree
Trine Moholdt, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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