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Time-restricted Eating and High-intensity Interval Training After Gestational Diabetes (TRE-HIITmoms)

17 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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

Tipo di studio

Interventistico

Iscrizione (Stimato)

56

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Norvegia
      • Trondheim, Norvegia, 7491
        • Department of Circulation and Medical Imaging
        • Investigatore principale:
          • Trine Moholdt, PhD
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention
Time-restricted eating and high-intensity interval training
Comportamentale: Time-restricted eating and exercise
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.
Altri nomi:
  • Esercizio
  • Dieta
Nessun intervento: Control
No intervention administered

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Peak oxygen uptake
Lasso di tempo: From baseline to after 8 weeks
Direct measurement of oxygen uptake during graded maximal exercise test to exhaustion
From baseline to after 8 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Peak oxygen uptake
Lasso di tempo: 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
Lasso di tempo: From baseline to after 8 weeks
Estimated by bioimpedance scale
From baseline to after 8 weeks
Body mass
Lasso di tempo: From baseline to after 12 months
Estimated by bioimpedance scale
From baseline to after 12 months
Fat mass
Lasso di tempo: From baseline to after 8 weeks
Estimated by bioimpedance scale
From baseline to after 8 weeks
Fat mass
Lasso di tempo: From baseline to after 12 months
Estimated by bioimpedance scale
From baseline to after 12 months
Muscle mass
Lasso di tempo: From baseline to after 8 weeks
Estimated by bioimpedance scale
From baseline to after 8 weeks
Muscle mass
Lasso di tempo: From baseline to after 12 months
Estimated by bioimpedance scale
From baseline to after 12 months
Visceral fat area
Lasso di tempo: From baseline to after 8 weeks
Estimated by bioimpedance scale
From baseline to after 8 weeks
Visceral fat area
Lasso di tempo: From baseline to after 12 months
Estimated by bioimpedance scale
From baseline to after 12 months
Bone mass
Lasso di tempo: From baseline to after 8 weeks
Estimated by bioimpedance scale
From baseline to after 8 weeks
Bone mass
Lasso di tempo: From baseline to after 12 months
Estimated by bioimpedance scale
From baseline to after 12 months
Waist circumference
Lasso di tempo: From baseline to after 8 weeks
Measured by measuring tape at the level of the umbilicus
From baseline to after 8 weeks
Waist circumference
Lasso di tempo: 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
Lasso di tempo: From baseline to after 8 weeks
Measured by automatic blood pressure cuff
From baseline to after 8 weeks
Systolic blood pressure
Lasso di tempo: From baseline to after 12 months
Measured by automatic blood pressure cuff
From baseline to after 12 months
Diastolic blood pressure
Lasso di tempo: From baseline to after 8 weeks
Measured by automatic blood pressure cuff
From baseline to after 8 weeks
Diastolic blood pressure
Lasso di tempo: From baseline to after 12 months
Measured by automatic blood pressure cuff
From baseline to after 12 months
Resting heart rate
Lasso di tempo: From baseline to after 8 weeks
Measured by automatic blood pressure cuff
From baseline to after 8 weeks
Resting heart rate
Lasso di tempo: From baseline to after 12 months
Measured by automatic blood pressure cuff
From baseline to after 12 months
Blood cholesterol
Lasso di tempo: From baseline to after 8 weeks
Venous blood sampling
From baseline to after 8 weeks
Blood cholesterol
Lasso di tempo: From baseline to after 12 months
Venous blood sampling
From baseline to after 12 months
LDL cholesterol
Lasso di tempo: From baseline to after 8 weeks
Venous blood sampling
From baseline to after 8 weeks
LDL cholesterol
Lasso di tempo: From baseline to after 12 months
Venous blood sampling
From baseline to after 12 months
HDL cholesterol
Lasso di tempo: From baseline to after 8 weeks
Venous blood sampling
From baseline to after 8 weeks
HDL cholesterol
Lasso di tempo: From baseline to after 12 months
Venous blood sampling
From baseline to after 12 months
Triglycerides
Lasso di tempo: From baseline to after 8 weeks
Venous blood sampling
From baseline to after 8 weeks
Triglycerides
Lasso di tempo: From baseline to after 12 months
Venous blood sampling
From baseline to after 12 months
Fasting glucose
Lasso di tempo: From baseline to after 8 weeks
Venous blood sampling
From baseline to after 8 weeks
Fasting glucose
Lasso di tempo: From baseline to after 12 months
Venous blood sampling
From baseline to after 12 months
Insulin C-peptide
Lasso di tempo: From baseline to after 8 weeks
Venous blood sampling
From baseline to after 8 weeks
Insulin C-peptide
Lasso di tempo: From baseline to after 12 months
Venous blood sampling
From baseline to after 12 months
Plasma glucose after oral glucose tolerance test
Lasso di tempo: 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
Lasso di tempo: From baseline to after 12 months
Venous blood sampling 120 minutes after ingesting 75 gram glucose
From baseline to after 12 months
Dietary intake
Lasso di tempo: From baseline to after 8 weeks
Self-reported dietary intake using electronic application
From baseline to after 8 weeks
Dietary intake
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: From baseline to after 8 weeks
International Physical Activity Questionnaire
From baseline to after 8 weeks
Self-reported physical activity
Lasso di tempo: From baseline to after 12 months
International Physical Activity Questionnaire
From baseline to after 12 months
Psychological wellbeing
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Infant feeding method
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: After 12 months
Qualitative interviews with selected participants to explore barriers and motivators
After 12 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Norwegian University of Science and Technology

Collaboratori

St. Olavs Hospital

Investigatori

  • Investigatore principale: Trine Moholdt, PhD, Norwegian University of Science and Technology

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 agosto 2026

Completamento primario (Stimato)

1 dicembre 2028

Completamento dello studio (Stimato)

1 gennaio 2029

Date di iscrizione allo studio

Primo inviato

3 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

17 agosto 2026

Primo Inserito (Effettivo)

20 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 987380

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Periodo di condivisione IPD

Data will become available at the time of publication of the results from the study

Criteri di accesso alla condivisione 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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • CODICE_ANALITICO
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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