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

NCT05505305 | Completed

• 1 other identifier: 479143
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

time-restricted eating; high-intensity interval training; exercise; diet; body composition

Outcome Measures

Primary Outcomes (1)

• Total fat mass

  Change in total fat mass measured with bioelectrical impedance analysis

  From baseline to after 7 weeks of intervention

Secondary Outcomes (21)

• Blood glucose

  From baseline to after 7 weeks of intervention

• Insulin

  From baseline to after 7 weeks of intervention

• Average glucose levels

  From baseline to after 7 weeks of intervention

• Blood Cholesterol

  From baseline to after 7 weeks of intervention

• HDL-cholesterol in blood

  From baseline to after 7 weeks of intervention

Other Outcomes (6)

• Adherence to high-intensity interval training

  Seven weeks

• Compliance to high-intensity interval training

  Seven weeks

• Adherence to time-restricted eating

  Seven weeks

Study Arms (2)

Time-restricted eating and high-intensity interval training

EXPERIMENTAL

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

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

Control

NO INTERVENTION

No intervention nor digital follow-up for seven weeks.

Interventions

Time-restricted eating and high-intensity interval training BEHAVIORAL

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,

Time-restricted eating and high-intensity interval training

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index ≥ 27 kg/m²
• Able to walk or ride a bike \> 60 min

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead

Study Sites (1)

Department of circulation and medical imaging, NTNU

Trondheim, 7491, Norway

Location

MeSH Terms

Conditions

Overweight; Obesity; Intermittent Fasting; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Øivind Rognmo, PhD

  Norwegian University of Science and Technology, Trondheim, Norway

  STUDY DIRECTOR

• Trine Moholdt, PhD

  Norwegian University of Science and Technology, Trondheim, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 17, 2022
• Study Start: September 1, 2022
• Primary Completion: May 13, 2024
• Study Completion: May 13, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)