Time-restricted Eating and High-intensity Interval Training After Gestational Diabetes (TRE-HIITmoms)
17. srpna 2026 aktualizováno: Norwegian University of Science and Technology
Time-restricted Eating and High-intensity Interval Training After Gestational Diabetes (TRE-HIIT Moms)
This trial will recruit participants who had gestational diabetes in their most previous pregnancy.
Participants will be randomly allocated into two groups: one intervention group and one control group 6-12 weeks after giving birth.
The intervention group will undergo an 8-week supervised intervention consisting of time-restricted eating and endurance exercise training with moderate-to-high intensity.
The investigators will assess cardiorespiratory fitness, body composition, and other markers of cardiovascular and metabolic health before and after the 8 weeks.
Additionally, the participants in the intervention group will be encouraged to continue exercising and eating time restricted after the supervised period and follow them up by telephone until one year from the baseline visit.
The investigators will measure the same outcomes at the follow-up as on the previous two test points.
Přehled studie
Postavení
Zatím nenabíráme
Intervence / Léčba
Detailní popis
TREHIIT Moms is a randomised, controlled trial with two parallel groups. To be eligible for the trial, the participants need to have had gestational diabetes in their most previous pregnancy and be 6-12 weeks postpartum at inclusion. Participants will be randomly allocated to intervention or control (1:1). The intervention consist of time-restricted eating and endurance exercise. Time-restricted eating implies restricting energy intake to a maximum 10-hour time window daily. The exercise training will be supervised and consist of 2-4 weekly sessions of moderate-to-high intensity exercise. After the supervised period, the participants will continue high-intensity exercise and time-restricted eating at home, with follow-up from the researchers until 1 year from baseline.
The investigators will assess cardiometabolic health outcomes and psychological well-being at baseline, after 8 weeks, and 1 year. Human milk samples will be collected at baseline and 8 weeks and stored for future exploratory analyses of milk composition. The specific analytes and analytical methods will be determined in subsequent exploratory studies and are not prespecified trial outcomes
Typ studie
Intervenční
Zápis (Odhadovaný)
56
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Trine Moholdt, PhD
- Telefonní číslo: +4797098594
- E-mail: trine.moholdt@ntnu.no
Studijní záloha kontaktů
- Jméno: Beathe Sitter, PhD
- Telefonní číslo: +4799024180
- E-mail: beathe.sitter@ntnu.no
Studijní místa
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Trondheim, Norsko, 7491
- Department of Circulation and Medical Imaging
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Vrchní vyšetřovatel:
- Trine Moholdt, PhD
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Kontakt:
- Trine Moholdt, PhD
- Telefonní číslo: +4797098594
- E-mail: trine.moholdt@ntnu.no
-
Kontakt:
- Beathe Sitter, PhD
- Telefonní číslo: +4799024180
- E-mail: beathe.sitter@ntnu.no
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
Inclusion Criteria:
- Gestational diabetes mellitus in most recent pregnancy
- Within 6-12 weeks postpartum
- Understands oral and written Norwegian or English
- Able to walk or run on a treadmill or ride a bike for at least 60 minutes
- Living in the Trondheim area
Exclusion Criteria:
- Pregnant or trying to become pregnant
- Diagnosed with type 1 or type 2 diabetes
- Diagnosed with cardiovascular disease
- Have a history of eating disorders (anorexia, bulimia, or binge eating disorder)
- Habitual eating window of less than 12 hours/day
- Engaging in regular high-intensity endurance training (once per week or more)
- Intention of starting an exercise programme and/or a dietary strategy within the study period
- Shift work that includes night shifts
- Bariatric surgery
- Any other reason which, according to the researchers, makes the potential participant ineligible
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Intervention
Time-restricted eating and high-intensity interval training
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The intervention is a combination of time-restricted eating and endurance exercise training.
Time-restricted eating implies that the participants will be asked to limit their energy intake to a maximum 10-hour time window daily.
The endurance exercise programme consists of 2-4 weekly supervised exercise sessions for 8 weeks.
Thereafter, the participants will continue exercising unsupervised with weekly follow-up from researchers.
Ostatní jména:
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Žádný zásah: Control
No intervention administered
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Peak oxygen uptake
Časové okno: From baseline to after 8 weeks
|
Direct measurement of oxygen uptake during graded maximal exercise test to exhaustion
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From baseline to after 8 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Peak oxygen uptake
Časové okno: From baseline to after 12 months
|
Direct measurement of oxygen uptake during graded maximal exercise test to exhaustion
|
From baseline to after 12 months
|
|
Body mass
Časové okno: From baseline to after 8 weeks
|
Estimated by bioimpedance scale
|
From baseline to after 8 weeks
|
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Body mass
Časové okno: From baseline to after 12 months
|
Estimated by bioimpedance scale
|
From baseline to after 12 months
|
|
Fat mass
Časové okno: From baseline to after 8 weeks
|
Estimated by bioimpedance scale
|
From baseline to after 8 weeks
|
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Fat mass
Časové okno: From baseline to after 12 months
|
Estimated by bioimpedance scale
|
From baseline to after 12 months
|
|
Muscle mass
Časové okno: From baseline to after 8 weeks
|
Estimated by bioimpedance scale
|
From baseline to after 8 weeks
|
|
Muscle mass
Časové okno: From baseline to after 12 months
|
Estimated by bioimpedance scale
|
From baseline to after 12 months
|
|
Visceral fat area
Časové okno: From baseline to after 8 weeks
|
Estimated by bioimpedance scale
|
From baseline to after 8 weeks
|
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Visceral fat area
Časové okno: From baseline to after 12 months
|
Estimated by bioimpedance scale
|
From baseline to after 12 months
|
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Bone mass
Časové okno: From baseline to after 8 weeks
|
Estimated by bioimpedance scale
|
From baseline to after 8 weeks
|
|
Bone mass
Časové okno: From baseline to after 12 months
|
Estimated by bioimpedance scale
|
From baseline to after 12 months
|
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Waist circumference
Časové okno: From baseline to after 8 weeks
|
Measured by measuring tape at the level of the umbilicus
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From baseline to after 8 weeks
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Waist circumference
Časové okno: From baseline to after 12 months
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Measured by measuring tape at the level of the umbilicus
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From baseline to after 12 months
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Systolic blood pressure
Časové okno: From baseline to after 8 weeks
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Measured by automatic blood pressure cuff
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From baseline to after 8 weeks
|
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Systolic blood pressure
Časové okno: From baseline to after 12 months
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Measured by automatic blood pressure cuff
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From baseline to after 12 months
|
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Diastolic blood pressure
Časové okno: From baseline to after 8 weeks
|
Measured by automatic blood pressure cuff
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From baseline to after 8 weeks
|
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Diastolic blood pressure
Časové okno: From baseline to after 12 months
|
Measured by automatic blood pressure cuff
|
From baseline to after 12 months
|
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Resting heart rate
Časové okno: From baseline to after 8 weeks
|
Measured by automatic blood pressure cuff
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From baseline to after 8 weeks
|
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Resting heart rate
Časové okno: From baseline to after 12 months
|
Measured by automatic blood pressure cuff
|
From baseline to after 12 months
|
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Blood cholesterol
Časové okno: From baseline to after 8 weeks
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Venous blood sampling
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From baseline to after 8 weeks
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Blood cholesterol
Časové okno: From baseline to after 12 months
|
Venous blood sampling
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From baseline to after 12 months
|
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LDL cholesterol
Časové okno: From baseline to after 8 weeks
|
Venous blood sampling
|
From baseline to after 8 weeks
|
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LDL cholesterol
Časové okno: From baseline to after 12 months
|
Venous blood sampling
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From baseline to after 12 months
|
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HDL cholesterol
Časové okno: From baseline to after 8 weeks
|
Venous blood sampling
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From baseline to after 8 weeks
|
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HDL cholesterol
Časové okno: From baseline to after 12 months
|
Venous blood sampling
|
From baseline to after 12 months
|
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Triglycerides
Časové okno: From baseline to after 8 weeks
|
Venous blood sampling
|
From baseline to after 8 weeks
|
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Triglycerides
Časové okno: From baseline to after 12 months
|
Venous blood sampling
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From baseline to after 12 months
|
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Fasting glucose
Časové okno: From baseline to after 8 weeks
|
Venous blood sampling
|
From baseline to after 8 weeks
|
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Fasting glucose
Časové okno: From baseline to after 12 months
|
Venous blood sampling
|
From baseline to after 12 months
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Insulin C-peptide
Časové okno: From baseline to after 8 weeks
|
Venous blood sampling
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From baseline to after 8 weeks
|
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Insulin C-peptide
Časové okno: From baseline to after 12 months
|
Venous blood sampling
|
From baseline to after 12 months
|
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Plasma glucose after oral glucose tolerance test
Časové okno: From baseline to after 8 weeks
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Venous blood sampling 120 minutes after ingesting 75 gram glucose
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From baseline to after 8 weeks
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Plasma glucose after oral glucose tolerance test
Časové okno: From baseline to after 12 months
|
Venous blood sampling 120 minutes after ingesting 75 gram glucose
|
From baseline to after 12 months
|
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Dietary intake
Časové okno: From baseline to after 8 weeks
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Self-reported dietary intake using electronic application
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From baseline to after 8 weeks
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Dietary intake
Časové okno: From baseline to after 12 months
|
Self-reported dietary intake using electronic application
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From baseline to after 12 months
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Mean Daily Minutes of Moderate-to-Vigorous Physical Activity Measured by ActiGraph Accelerometer
Časové okno: From baseline to after 8 weeks
|
Participants will wear an ActiGraph accelerometer for 7 consecutive days. Moderate-to-vigorous physical activity will be determined using prespecified accelerometer count thresholds. For each participant, the total number of minutes classified as moderate-to-vigorous physical activity will be calculated for each valid wear day and averaged across all valid wear days. The reported value will be mean minutes of moderate-to-vigorous physical activity per day. A valid day will be defined as at least 10 hours of accelerometer wear, and participants must have at least 4 valid days to be included in the analysis. |
From baseline to after 8 weeks
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Mean Daily Minutes of Moderate-to-Vigorous Physical Activity Measured by ActiGraph Accelerometer
Časové okno: From baseline to after 12 months
|
Participants will wear an ActiGraph accelerometer for 7 consecutive days. Moderate-to-vigorous physical activity will be determined using prespecified accelerometer count thresholds. For each participant, the total number of minutes classified as moderate-to-vigorous physical activity will be calculated for each valid wear day and averaged across all valid wear days. The reported value will be mean minutes of moderate-to-vigorous physical activity per day. A valid day will be defined as at least 10 hours of accelerometer wear, and participants must have at least 4 valid days to be included in the analysis. |
From baseline to after 12 months
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Self-reported physical activity
Časové okno: From baseline to after 8 weeks
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International Physical Activity Questionnaire
|
From baseline to after 8 weeks
|
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Self-reported physical activity
Časové okno: From baseline to after 12 months
|
International Physical Activity Questionnaire
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From baseline to after 12 months
|
|
Psychological wellbeing
Časové okno: From baseline to after 8 weeks
|
World Health Organization Five Well-Being Index (WHO-5).
The World Health Organization Five Well-Being Index (WHO-5) is a 5-item self-report questionnaire assessing subjective psychological well-being over the previous 2 weeks.
Raw scores are transformed to a scale ranging from 0 to 100 by multiplying the total raw score by 4. Higher scores indicate better well-being.
|
From baseline to after 8 weeks
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Psychological wellbeing
Časové okno: From baseline to after 12 months
|
World Health Organization Five Well-Being Index (WHO-5).
The World Health Organization Five Well-Being Index (WHO-5) is a 5-item self-report questionnaire assessing subjective psychological well-being over the previous 2 weeks.
Raw scores are transformed to a scale ranging from 0 to 100 by multiplying the total raw score by 4. Higher scores indicate better well-being.
|
From baseline to after 12 months
|
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Sleep quality
Časové okno: From baseline to after 8 weeks
|
Pittsburgh Sleep Quality Index questionnaire global score.
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire that assesses sleep quality over the previous month.
The global PSQI score ranges from 0 to 21, with higher scores indicating worse sleep quality.
|
From baseline to after 8 weeks
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Sleep quality
Časové okno: From baseline to after 12 months
|
Pittsburgh Sleep Quality Index questionnaire global score.
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire that assesses sleep quality over the previous month.
The global PSQI score ranges from 0 to 21, with higher scores indicating worse sleep quality.
|
From baseline to after 12 months
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Depression
Časové okno: From baseline to 8 weeks
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The Edinburgh Postnatal Depression Scale (EPDS) global score.
The Edinburgh Postnatal Depression Scale is a 10-item self-report questionnaire that assesses symptoms of depression over the previous 7 days.
The total score ranges from 0 to 30, with higher scores indicating more severe depressive symptoms.
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From baseline to 8 weeks
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Depression
Časové okno: From baseline to after 12 months
|
The Edinburgh Postnatal Depression Scale (EPDS) global score.
The Edinburgh Postnatal Depression Scale is a 10-item self-report questionnaire that assesses symptoms of depression over the previous 7 days.
The total score ranges from 0 to 30, with higher scores indicating more severe depressive symptoms.
|
From baseline to after 12 months
|
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Anxiety
Časové okno: From baseline to after 8 weeks
|
Generalised anxiety disorder questionnaire (GAD-7) total score.
The Generalized Anxiety Disorder 7-Item (GAD-7) is a 7-item self-report questionnaire that assesses symptoms of generalized anxiety over the previous 2 weeks.
The total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.
|
From baseline to after 8 weeks
|
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Anxiety
Časové okno: From baseline to after 12 months
|
Generalised anxiety disorder questionnaire (GAD-7) total score.
The Generalized Anxiety Disorder 7-Item (GAD-7) is a 7-item self-report questionnaire that assesses symptoms of generalized anxiety over the previous 2 weeks.
The total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.
|
From baseline to after 12 months
|
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Type 2 diabetes mellitus diagnosis
Časové okno: During the 12-month follow-up
|
Participant-reported or measurement of HbA1c of 48 mmol/mol or above
|
During the 12-month follow-up
|
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Mean Daily Step Count Measured by ActiGraph Accelerometer
Časové okno: From baseline to after 8 weeks
|
Participants will wear an ActiGraph accelerometer for 7 consecutive days.
The number of steps recorded on each valid wear day will be averaged across all valid wear days for each participant.
A valid day will be defined as at least 10 hours of accelerometer wear, and at least 4 valid days will be required.
|
From baseline to after 8 weeks
|
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Mean Daily Sedentary Time Measured by ActiGraph Accelerometer
Časové okno: At baseline and after 8 weeks
|
Participants will wear an ActiGraph accelerometer for 7 consecutive days.
Sedentary time will be identified using a prespecified accelerometer count threshold.
Minutes classified as sedentary will be calculated for each valid wear day and averaged across all valid wear days for each participant.
A valid day will be defined as at least 10 hours of accelerometer wear, and at least 4 valid days will be required.
|
At baseline and after 8 weeks
|
|
Mean Daily Step Count Measured by ActiGraph Accelerometer
Časové okno: From baseline to after 12 months
|
Participants will wear an ActiGraph accelerometer for 7 consecutive days.
The number of steps recorded on each valid wear day will be averaged across all valid wear days for each participant.
A valid day will be defined as at least 10 hours of accelerometer wear, and at least 4 valid days will be required.
|
From baseline to after 12 months
|
|
Mean Daily Sedentary Time Measured by ActiGraph Accelerometer
Časové okno: From baseline to after 12 months
|
Participants will wear an ActiGraph accelerometer for 7 consecutive days.
Sedentary time will be identified using a prespecified accelerometer count threshold.
Minutes classified as sedentary will be calculated for each valid wear day and averaged across all valid wear days for each participant.
A valid day will be defined as at least 10 hours of accelerometer wear, and at least 4 valid days will be required.
|
From baseline to after 12 months
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Infant feeding method
Časové okno: Baseline, 8 weeks, and after 12 months
|
Infant feeding practices will be assessed using a study questionnaire.
Feeding method will be categorized as exclusive breastfeeding, partial breastfeeding, exclusive formula feeding, or complementary feeding, as appropriate for the infant's age.
The number and proportion of infants in each feeding category will be reported at each assessment.
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Baseline, 8 weeks, and after 12 months
|
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Adherence to time-restricted eating
Časové okno: Baseline, after 8 weeks and after 12 months
|
Time-frame for daily energy intake, reported as average and percentage of participants who adhere to < 10 hours daily energy intake window
|
Baseline, after 8 weeks and after 12 months
|
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Adherence to exercise training
Časové okno: During the 8-week intervention and during the 12-month follow-up
|
Number of completed sessions, recorded using an electronic application
|
During the 8-week intervention and during the 12-month follow-up
|
|
Perception of intervention and follow-up
Časové okno: After 12 months
|
Qualitative interviews with selected participants to explore barriers and motivators
|
After 12 months
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Trine Moholdt, PhD, Norwegian University of Science and Technology
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
15. srpna 2026
Primární dokončení (Odhadovaný)
1. prosince 2028
Dokončení studie (Odhadovaný)
1. ledna 2029
Termíny zápisu do studia
První předloženo
3. července 2026
První předloženo, které splnilo kritéria kontroly kvality
17. srpna 2026
První zveřejněno (Aktuální)
20. srpna 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
20. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
17. srpna 2026
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 987380
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
We will make de-identified individual participant data (IPD) collected in the study available to other researchers. We will upload a data set in an open access repository.
We will only share IPD that cannot be used to identify individuals.
Časový rámec sdílení IPD
Data will become available at the time of publication of the results from the study
Kritéria přístupu pro sdílení IPD
De-identified individual participant data underlying published results will be available upon reasonable request following publication of the primary study results.
Requests must be accompanied by a research proposal and statistical analysis plan. Requests will be reviewed by the Principal Investigator and study investigators for scientific merit, feasibility, consistency with participant consent, and compliance with applicable ethical and legal requirements. Approved researchers will be required to sign a data sharing agreement.
Only de-identified data will be shared. Data may be modified as necessary to minimize the risk of participant re-identification while preserving scientific utility.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ANALYTIC_CODE
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .