Time-restricted Eating and High-intensity Interval Training After Gestational Diabetes (TRE-HIITmoms)
17. August 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Intervention / Behandlung
Detaillierte Beschreibung
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
Studientyp
Interventionell
Einschreibung (Geschätzt)
56
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Trine Moholdt, PhD
- Telefonnummer: +4797098594
- E-Mail: trine.moholdt@ntnu.no
Studieren Sie die Kontaktsicherung
- Name: Beathe Sitter, PhD
- Telefonnummer: +4799024180
- E-Mail: beathe.sitter@ntnu.no
Studienorte
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Trondheim, Norwegen, 7491
- Department of Circulation and Medical Imaging
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Hauptermittler:
- Trine Moholdt, PhD
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Kontakt:
- Trine Moholdt, PhD
- Telefonnummer: +4797098594
- E-Mail: trine.moholdt@ntnu.no
-
Kontakt:
- Beathe Sitter, PhD
- Telefonnummer: +4799024180
- E-Mail: beathe.sitter@ntnu.no
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-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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.
Andere Namen:
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Kein Eingriff: Control
No intervention administered
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Peak oxygen uptake
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Peak oxygen uptake
Zeitfenster: 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
Zeitfenster: From baseline to after 8 weeks
|
Estimated by bioimpedance scale
|
From baseline to after 8 weeks
|
|
Body mass
Zeitfenster: From baseline to after 12 months
|
Estimated by bioimpedance scale
|
From baseline to after 12 months
|
|
Fat mass
Zeitfenster: From baseline to after 8 weeks
|
Estimated by bioimpedance scale
|
From baseline to after 8 weeks
|
|
Fat mass
Zeitfenster: From baseline to after 12 months
|
Estimated by bioimpedance scale
|
From baseline to after 12 months
|
|
Muscle mass
Zeitfenster: From baseline to after 8 weeks
|
Estimated by bioimpedance scale
|
From baseline to after 8 weeks
|
|
Muscle mass
Zeitfenster: From baseline to after 12 months
|
Estimated by bioimpedance scale
|
From baseline to after 12 months
|
|
Visceral fat area
Zeitfenster: From baseline to after 8 weeks
|
Estimated by bioimpedance scale
|
From baseline to after 8 weeks
|
|
Visceral fat area
Zeitfenster: From baseline to after 12 months
|
Estimated by bioimpedance scale
|
From baseline to after 12 months
|
|
Bone mass
Zeitfenster: From baseline to after 8 weeks
|
Estimated by bioimpedance scale
|
From baseline to after 8 weeks
|
|
Bone mass
Zeitfenster: From baseline to after 12 months
|
Estimated by bioimpedance scale
|
From baseline to after 12 months
|
|
Waist circumference
Zeitfenster: From baseline to after 8 weeks
|
Measured by measuring tape at the level of the umbilicus
|
From baseline to after 8 weeks
|
|
Waist circumference
Zeitfenster: 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
Zeitfenster: From baseline to after 8 weeks
|
Measured by automatic blood pressure cuff
|
From baseline to after 8 weeks
|
|
Systolic blood pressure
Zeitfenster: From baseline to after 12 months
|
Measured by automatic blood pressure cuff
|
From baseline to after 12 months
|
|
Diastolic blood pressure
Zeitfenster: From baseline to after 8 weeks
|
Measured by automatic blood pressure cuff
|
From baseline to after 8 weeks
|
|
Diastolic blood pressure
Zeitfenster: From baseline to after 12 months
|
Measured by automatic blood pressure cuff
|
From baseline to after 12 months
|
|
Resting heart rate
Zeitfenster: From baseline to after 8 weeks
|
Measured by automatic blood pressure cuff
|
From baseline to after 8 weeks
|
|
Resting heart rate
Zeitfenster: From baseline to after 12 months
|
Measured by automatic blood pressure cuff
|
From baseline to after 12 months
|
|
Blood cholesterol
Zeitfenster: From baseline to after 8 weeks
|
Venous blood sampling
|
From baseline to after 8 weeks
|
|
Blood cholesterol
Zeitfenster: From baseline to after 12 months
|
Venous blood sampling
|
From baseline to after 12 months
|
|
LDL cholesterol
Zeitfenster: From baseline to after 8 weeks
|
Venous blood sampling
|
From baseline to after 8 weeks
|
|
LDL cholesterol
Zeitfenster: From baseline to after 12 months
|
Venous blood sampling
|
From baseline to after 12 months
|
|
HDL cholesterol
Zeitfenster: From baseline to after 8 weeks
|
Venous blood sampling
|
From baseline to after 8 weeks
|
|
HDL cholesterol
Zeitfenster: From baseline to after 12 months
|
Venous blood sampling
|
From baseline to after 12 months
|
|
Triglycerides
Zeitfenster: From baseline to after 8 weeks
|
Venous blood sampling
|
From baseline to after 8 weeks
|
|
Triglycerides
Zeitfenster: From baseline to after 12 months
|
Venous blood sampling
|
From baseline to after 12 months
|
|
Fasting glucose
Zeitfenster: From baseline to after 8 weeks
|
Venous blood sampling
|
From baseline to after 8 weeks
|
|
Fasting glucose
Zeitfenster: From baseline to after 12 months
|
Venous blood sampling
|
From baseline to after 12 months
|
|
Insulin C-peptide
Zeitfenster: From baseline to after 8 weeks
|
Venous blood sampling
|
From baseline to after 8 weeks
|
|
Insulin C-peptide
Zeitfenster: From baseline to after 12 months
|
Venous blood sampling
|
From baseline to after 12 months
|
|
Plasma glucose after oral glucose tolerance test
Zeitfenster: From baseline to after 8 weeks
|
Venous blood sampling 120 minutes after ingesting 75 gram glucose
|
From baseline to after 8 weeks
|
|
Plasma glucose after oral glucose tolerance test
Zeitfenster: From baseline to after 12 months
|
Venous blood sampling 120 minutes after ingesting 75 gram glucose
|
From baseline to after 12 months
|
|
Dietary intake
Zeitfenster: From baseline to after 8 weeks
|
Self-reported dietary intake using electronic application
|
From baseline to after 8 weeks
|
|
Dietary intake
Zeitfenster: 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
Zeitfenster: 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
|
|
Mean Daily Minutes of Moderate-to-Vigorous Physical Activity Measured by ActiGraph Accelerometer
Zeitfenster: 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
|
|
Self-reported physical activity
Zeitfenster: From baseline to after 8 weeks
|
International Physical Activity Questionnaire
|
From baseline to after 8 weeks
|
|
Self-reported physical activity
Zeitfenster: From baseline to after 12 months
|
International Physical Activity Questionnaire
|
From baseline to after 12 months
|
|
Psychological wellbeing
Zeitfenster: 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
|
|
Psychological wellbeing
Zeitfenster: 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
Zeitfenster: 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
|
|
Sleep quality
Zeitfenster: 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
|
|
Depression
Zeitfenster: 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
|
|
Depression
Zeitfenster: 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
|
|
Anxiety
Zeitfenster: 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
Zeitfenster: 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
|
|
Type 2 diabetes mellitus diagnosis
Zeitfenster: During the 12-month follow-up
|
Participant-reported or measurement of HbA1c of 48 mmol/mol or above
|
During the 12-month follow-up
|
|
Mean Daily Step Count Measured by ActiGraph Accelerometer
Zeitfenster: 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
|
|
Mean Daily Sedentary Time Measured by ActiGraph Accelerometer
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Infant feeding method
Zeitfenster: 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
|
|
Adherence to time-restricted eating
Zeitfenster: 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
|
|
Adherence to exercise training
Zeitfenster: 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
Zeitfenster: After 12 months
|
Qualitative interviews with selected participants to explore barriers and motivators
|
After 12 months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Hauptermittler: Trine Moholdt, PhD, Norwegian University of Science and Technology
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
15. August 2026
Primärer Abschluss (Geschätzt)
1. Dezember 2028
Studienabschluss (Geschätzt)
1. Januar 2029
Studienanmeldedaten
Zuerst eingereicht
3. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
17. August 2026
Zuerst gepostet (Tatsächlich)
20. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
20. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
17. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 987380
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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.
IPD-Sharing-Zeitrahmen
Data will become available at the time of publication of the results from the study
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ANALYTIC_CODE
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .