Time-restricted Eating and High-intensity Interval Training After Gestational Diabetes (TRE-HIITmoms)
17 sierpnia 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Interwencyjne
Zapisy (Szacowany)
56
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Trine Moholdt, PhD
- Numer telefonu: +4797098594
- E-mail: trine.moholdt@ntnu.no
Kopia zapasowa kontaktu do badania
- Nazwa: Beathe Sitter, PhD
- Numer telefonu: +4799024180
- E-mail: beathe.sitter@ntnu.no
Lokalizacje studiów
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Trondheim, Norwegia, 7491
- Department of Circulation and Medical Imaging
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Główny śledczy:
- Trine Moholdt, PhD
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Kontakt:
- Trine Moholdt, PhD
- Numer telefonu: +4797098594
- E-mail: trine.moholdt@ntnu.no
-
Kontakt:
- Beathe Sitter, PhD
- Numer telefonu: +4799024180
- E-mail: beathe.sitter@ntnu.no
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-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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.
Inne nazwy:
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Brak interwencji: Control
No intervention administered
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Peak oxygen uptake
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Peak oxygen uptake
Ramy czasowe: 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
Ramy czasowe: From baseline to after 8 weeks
|
Estimated by bioimpedance scale
|
From baseline to after 8 weeks
|
|
Body mass
Ramy czasowe: From baseline to after 12 months
|
Estimated by bioimpedance scale
|
From baseline to after 12 months
|
|
Fat mass
Ramy czasowe: From baseline to after 8 weeks
|
Estimated by bioimpedance scale
|
From baseline to after 8 weeks
|
|
Fat mass
Ramy czasowe: From baseline to after 12 months
|
Estimated by bioimpedance scale
|
From baseline to after 12 months
|
|
Muscle mass
Ramy czasowe: From baseline to after 8 weeks
|
Estimated by bioimpedance scale
|
From baseline to after 8 weeks
|
|
Muscle mass
Ramy czasowe: From baseline to after 12 months
|
Estimated by bioimpedance scale
|
From baseline to after 12 months
|
|
Visceral fat area
Ramy czasowe: From baseline to after 8 weeks
|
Estimated by bioimpedance scale
|
From baseline to after 8 weeks
|
|
Visceral fat area
Ramy czasowe: From baseline to after 12 months
|
Estimated by bioimpedance scale
|
From baseline to after 12 months
|
|
Bone mass
Ramy czasowe: From baseline to after 8 weeks
|
Estimated by bioimpedance scale
|
From baseline to after 8 weeks
|
|
Bone mass
Ramy czasowe: From baseline to after 12 months
|
Estimated by bioimpedance scale
|
From baseline to after 12 months
|
|
Waist circumference
Ramy czasowe: From baseline to after 8 weeks
|
Measured by measuring tape at the level of the umbilicus
|
From baseline to after 8 weeks
|
|
Waist circumference
Ramy czasowe: From baseline to after 12 months
|
Measured by measuring tape at the level of the umbilicus
|
From baseline to after 12 months
|
|
Systolic blood pressure
Ramy czasowe: From baseline to after 8 weeks
|
Measured by automatic blood pressure cuff
|
From baseline to after 8 weeks
|
|
Systolic blood pressure
Ramy czasowe: From baseline to after 12 months
|
Measured by automatic blood pressure cuff
|
From baseline to after 12 months
|
|
Diastolic blood pressure
Ramy czasowe: From baseline to after 8 weeks
|
Measured by automatic blood pressure cuff
|
From baseline to after 8 weeks
|
|
Diastolic blood pressure
Ramy czasowe: From baseline to after 12 months
|
Measured by automatic blood pressure cuff
|
From baseline to after 12 months
|
|
Resting heart rate
Ramy czasowe: From baseline to after 8 weeks
|
Measured by automatic blood pressure cuff
|
From baseline to after 8 weeks
|
|
Resting heart rate
Ramy czasowe: From baseline to after 12 months
|
Measured by automatic blood pressure cuff
|
From baseline to after 12 months
|
|
Blood cholesterol
Ramy czasowe: From baseline to after 8 weeks
|
Venous blood sampling
|
From baseline to after 8 weeks
|
|
Blood cholesterol
Ramy czasowe: From baseline to after 12 months
|
Venous blood sampling
|
From baseline to after 12 months
|
|
LDL cholesterol
Ramy czasowe: From baseline to after 8 weeks
|
Venous blood sampling
|
From baseline to after 8 weeks
|
|
LDL cholesterol
Ramy czasowe: From baseline to after 12 months
|
Venous blood sampling
|
From baseline to after 12 months
|
|
HDL cholesterol
Ramy czasowe: From baseline to after 8 weeks
|
Venous blood sampling
|
From baseline to after 8 weeks
|
|
HDL cholesterol
Ramy czasowe: From baseline to after 12 months
|
Venous blood sampling
|
From baseline to after 12 months
|
|
Triglycerides
Ramy czasowe: From baseline to after 8 weeks
|
Venous blood sampling
|
From baseline to after 8 weeks
|
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Triglycerides
Ramy czasowe: From baseline to after 12 months
|
Venous blood sampling
|
From baseline to after 12 months
|
|
Fasting glucose
Ramy czasowe: From baseline to after 8 weeks
|
Venous blood sampling
|
From baseline to after 8 weeks
|
|
Fasting glucose
Ramy czasowe: From baseline to after 12 months
|
Venous blood sampling
|
From baseline to after 12 months
|
|
Insulin C-peptide
Ramy czasowe: From baseline to after 8 weeks
|
Venous blood sampling
|
From baseline to after 8 weeks
|
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Insulin C-peptide
Ramy czasowe: From baseline to after 12 months
|
Venous blood sampling
|
From baseline to after 12 months
|
|
Plasma glucose after oral glucose tolerance test
Ramy czasowe: From baseline to after 8 weeks
|
Venous blood sampling 120 minutes after ingesting 75 gram glucose
|
From baseline to after 8 weeks
|
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Plasma glucose after oral glucose tolerance test
Ramy czasowe: From baseline to after 12 months
|
Venous blood sampling 120 minutes after ingesting 75 gram glucose
|
From baseline to after 12 months
|
|
Dietary intake
Ramy czasowe: From baseline to after 8 weeks
|
Self-reported dietary intake using electronic application
|
From baseline to after 8 weeks
|
|
Dietary intake
Ramy czasowe: From baseline to after 12 months
|
Self-reported dietary intake using electronic application
|
From baseline to after 12 months
|
|
Mean Daily Minutes of Moderate-to-Vigorous Physical Activity Measured by ActiGraph Accelerometer
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: From baseline to after 8 weeks
|
International Physical Activity Questionnaire
|
From baseline to after 8 weeks
|
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Self-reported physical activity
Ramy czasowe: From baseline to after 12 months
|
International Physical Activity Questionnaire
|
From baseline to after 12 months
|
|
Psychological wellbeing
Ramy czasowe: 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
Ramy czasowe: 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
|
|
Sleep quality
Ramy czasowe: 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.
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From baseline to after 8 weeks
|
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Sleep quality
Ramy czasowe: 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
Ramy czasowe: From baseline to 8 weeks
|
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 8 weeks
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Depression
Ramy czasowe: From baseline to after 12 months
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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 after 12 months
|
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Anxiety
Ramy czasowe: 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
|
|
Anxiety
Ramy czasowe: 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
Ramy czasowe: During the 12-month follow-up
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Participant-reported or measurement of HbA1c of 48 mmol/mol or above
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During the 12-month follow-up
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Mean Daily Step Count Measured by ActiGraph Accelerometer
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Infant feeding method
Ramy czasowe: 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.
|
Baseline, 8 weeks, and after 12 months
|
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Adherence to time-restricted eating
Ramy czasowe: 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
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Baseline, after 8 weeks and after 12 months
|
|
Adherence to exercise training
Ramy czasowe: 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
|
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Perception of intervention and follow-up
Ramy czasowe: After 12 months
|
Qualitative interviews with selected participants to explore barriers and motivators
|
After 12 months
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Główny śledczy: Trine Moholdt, PhD, Norwegian University of Science and Technology
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
15 sierpnia 2026
Zakończenie podstawowe (Szacowany)
1 grudnia 2028
Ukończenie studiów (Szacowany)
1 stycznia 2029
Daty rejestracji na studia
Pierwszy przesłany
3 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
17 sierpnia 2026
Pierwszy wysłany (Rzeczywisty)
20 sierpnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
20 sierpnia 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
17 sierpnia 2026
Ostatnia weryfikacja
1 sierpnia 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Zachowanie
- Zachowanie żywieniowe
- Post
- Aktywność silnika
- Post przerywany
- Aktywność motoryczna
- Ruch
- Physiologiczne zjawiska mięśniowo -szkieletowe
- Zjawiska fizjologiczne mięśniowo -szkieletowe i nerwowe
- Dieta, żywność i odżywianie
- Zjawiska fizjologiczne
- Zjawiska fizjologiczne żywieniowe
- Ćwiczenia
- Dieta
Inne numery identyfikacyjne badania
- 987380
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu 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.
Ramy czasowe udostępniania IPD
Data will become available at the time of publication of the results from the study
Kryteria dostępu do udostępniania 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 informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ANALITYCZNY_KOD
- CSR
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .