Time-restricted Eating and High Intensity Interval Training Among Women
Isolated and Combined Effects of High Intensity Interval Training and Time Restricted Eating on Glycaemic Control in Reproductive-aged Women With Overweight or Obesity
2 other identifiers
interventional
131
1 country
1
Brief Summary
This project will determine the independent and combined effects of high intensity interval training and time-restricted eating on blood sugar regulation among women in reproductive-age who have overweight or obesity. The intervention period will be seven weeks. Before and after the intervention, blood sugar regulation, body composition and physical fitness will be measured and compared between groups who are doing either high intensity interval training, time-restricted eating, both high intensity interval training and time-restricted eating, or who are in a control group. Physical activity, sleep quality, continuous glucose monitoring, adherence to the interventions and hunger/satiety will also be measured.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2019
CompletedFirst Posted
Study publicly available on registry
July 15, 2019
CompletedStudy Start
First participant enrolled
August 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2021
CompletedSeptember 20, 2021
September 1, 2021
1.6 years
July 9, 2019
September 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glycaemic control
Total area under the plasma glucose curve over two hours after a 75 g oral glucose tolerance test
From baseline to after 7 weeks intervention
Secondary Outcomes (24)
Insulin sensitivity
From baseline to after 7 weeks intervention
Insulin levels after ingestion of glucose
From baseline to after 7 weeks intervention
Cardiorespiratory fitness
From baseline to after 7 weeks intervention
Body mass
From baseline to after 7 weeks intervention
Body fat mass
From baseline to after 7 weeks intervention
- +19 more secondary outcomes
Other Outcomes (6)
Adherence to high intensity interval training
Seven weeks
Compliance to high intensity interval training
Seven weeks
Compliance to time-restricted eating
Seven weeks
- +3 more other outcomes
Study Arms (4)
High Intensity Interval Training
EXPERIMENTALHigh intensity interval training for seven weeks. Three weekly, supervised training sessions.
Time-Restricted Eating
EXPERIMENTALTime-restricted eating for seven weeks. Maximal daily eating window of 10 hours.
High Intensity Interval Training & Time-Restricted Eating
EXPERIMENTALControl
NO INTERVENTIONWill be given information about the recommended level of physical activity for health benefits and a healthy diet.
Interventions
Three weekly, supervised exercise sessions with high intensity. Each session will last for 30-45 minutes. Intervention period will be seven weeks.
Restricted daily window of caloric intake to maximum 10 hours. Intervention period will be seven weeks.
Eligibility Criteria
You may qualify if:
- body mass index ≥ 27 kg/cm2,
- able to walk on a treadmill or ride a bike for at least 60 min.
You may not qualify if:
- Pregnancy, lactation within 24 weeks of study commencement
- known cardiovascular disease
- type 1 or 2 diabetes
- currently taking hypertension or glucose- or lipid-lowering medication
- habitual eating window \< 12 hours
- performing high intensity training more than once a week
- body mass variations \> 4 kg three months prior to study commencement
- shift work that includes night shifts.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of circulation and medical imaging , NTNU
Trondheim, 7491, Norway
Related Publications (3)
Haganes KL, Devlin BL, Orr RK, Moholdt T. Impact of Time-Restricted Eating and High-Intensity Exercise on Nutrient Intake in Women with Overweight/Obesity: Secondary Analysis of a Randomized Controlled Trial. Nutrients. 2025 Jan 8;17(2):218. doi: 10.3390/nu17020218.
PMID: 39861348DERIVEDHaganes KL, Silva CP, Eyjolfsdottir SK, Steen S, Grindberg M, Lydersen S, Hawley JA, Moholdt T. Time-restricted eating and exercise training improve HbA1c and body composition in women with overweight/obesity: A randomized controlled trial. Cell Metab. 2022 Oct 4;34(10):1457-1471.e4. doi: 10.1016/j.cmet.2022.09.003.
PMID: 36198292DERIVEDMoholdt T, Silva CP, Lydersen S, Hawley JA. Isolated and combined effects of high-intensity interval training and time-restricted eating on glycaemic control in reproductive-aged women with overweight or obesity: study protocol for a four-armed randomised controlled trial. BMJ Open. 2021 Feb 5;11(2):e040020. doi: 10.1136/bmjopen-2020-040020.
PMID: 33550228DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Øystein T Risa, PhD
Norwegian University of Science and Technology
- PRINCIPAL INVESTIGATOR
Trine T Moholdt, PhD
Norwegian University of Science and Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2019
First Posted
July 15, 2019
Study Start
August 12, 2019
Primary Completion
March 16, 2021
Study Completion
March 16, 2021
Last Updated
September 20, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share