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Completed

NCT Number: NCT05505305

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

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.

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Key information

Conditions

Overweight and Obesity Behavior Body Weight Fasting Feeding Behavior Intermittent Fasting Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of circulation and medical imaging, NTNU

Trondheim, 7491, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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,

Primary outcomes

  1. Total fat mass

    Time frame: From baseline to after 7 weeks of intervention

    Change in total fat mass measured with bioelectrical impedance analysis

Secondary outcomes

  1. Blood glucose

    Time frame: From baseline to after 7 weeks of intervention

    Fasting concentration of plasma glucose

  2. Insulin

    Time frame: From baseline to after 7 weeks of intervention

    Fasting concentration of plasma insulin C-peptide

  3. Average glucose levels

    Time frame: From baseline to after 7 weeks of intervention

    Glycated hemoglobin (HbA1c)

  4. Blood Cholesterol

    Time frame: From baseline to after 7 weeks of intervention

    Total fasting cholesterol in blood

  5. HDL-cholesterol in blood

    Time frame: From baseline to after 7 weeks of intervention

    Fasting high-density lipoprotein-cholesterol in blood

  6. LDL-cholesterol in blood

    Time frame: From baseline to after 7 weeks of intervention

    Fasting low-density lipoprotein-cholesterol in blood

  7. Triglycerides in blood

    Time frame: From baseline to after 7 weeks of intervention

    Fasting triglycerides in blood

  8. 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

  9. 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

  10. Body mass

    Time frame: From baseline to after 7 weeks of intervention

    In kg, estimated with bioelectrical impedance analysis

  11. Body fat-free mass

    Time frame: From baseline to after 7 weeks of intervention

    In kg, estimated with bioelectrical impedance analysis

  12. Visceral fat area

    Time frame: From baseline to after 7 weeks of intervention

    In cm², estimated with bioelectrical impedance analysis

  13. Systolic blood pressure

    Time frame: From baseline to after 7 weeks of intervention

    Average of three measurements during rest in seated position, in mmHg

  14. Diastolic blood pressure

    Time frame: From baseline to after 7 weeks of intervention

    Average of three measurements during rest in seated position, in mmHg

  15. 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

  16. Physical activity level

    Time frame: From baseline to after 7 weeks of intervention

    International Physical Activity Questionnaire, categorical score

  17. 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

  18. 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

  19. Sleep quality

    Time frame: From baseline to after 7 weeks of intervention

    The Pittsburgh Sleep Quality Index questionnaire

  20. 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

  21. 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

Other outcomes

  1. Adherence to high-intensity interval training

    Time frame: Seven weeks

    Number of completed exercise sessions out of those prescribed, in percentage

  2. Compliance to high-intensity interval training

    Time frame: Seven weeks

    Exercise intensity measured with pulse sensor. Heart rate percentage of individual heart rate maximum.

  3. 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

  4. Compliance to time-restricted eating

    Time frame: Seven weeks

    Average daily eating window, self-reported in hours/day

  5. Perception of intervention and digital follow-up

    Time frame: After seven weeks of intervention

    Qualitative questionnaire after seven weeks of intervention

  6. Sex differences

    Time frame: From baseline to after 7 weeks of intervention

    Sub-analyses of sex differences in the effectiveness of the intervention

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Official study title

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

Acronym: TREHIIT-DFU

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 17, 2022
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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