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NCT Number: NCT07776886

Time-restricted Eating and High-intensity Interval Training After Gestational Diabetes

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.

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Key information

Conditions

Gestational Diabetes Mellitus With Baby Delivered Behavior Fasting Feeding Behavior Intermittent Fasting Motor Activity

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Time-restricted eating and exercise

Behavioral

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.

Other names: Diet, Exercise

Primary outcomes

  1. Peak oxygen uptake

    Time frame: From baseline to after 8 weeks

    Direct measurement of oxygen uptake during graded maximal exercise test to exhaustion

Secondary outcomes

  1. Peak oxygen uptake

    Time frame: From baseline to after 12 months

    Direct measurement of oxygen uptake during graded maximal exercise test to exhaustion

  2. Body mass

    Time frame: From baseline to after 8 weeks

    Estimated by bioimpedance scale

  3. Body mass

    Time frame: From baseline to after 12 months

    Estimated by bioimpedance scale

  4. Fat mass

    Time frame: From baseline to after 8 weeks

    Estimated by bioimpedance scale

  5. Fat mass

    Time frame: From baseline to after 12 months

    Estimated by bioimpedance scale

  6. Muscle mass

    Time frame: From baseline to after 8 weeks

    Estimated by bioimpedance scale

  7. Muscle mass

    Time frame: From baseline to after 12 months

    Estimated by bioimpedance scale

  8. Visceral fat area

    Time frame: From baseline to after 8 weeks

    Estimated by bioimpedance scale

  9. Visceral fat area

    Time frame: From baseline to after 12 months

    Estimated by bioimpedance scale

  10. Bone mass

    Time frame: From baseline to after 8 weeks

    Estimated by bioimpedance scale

  11. Bone mass

    Time frame: From baseline to after 12 months

    Estimated by bioimpedance scale

  12. Waist circumference

    Time frame: From baseline to after 8 weeks

    Measured by measuring tape at the level of the umbilicus

  13. Waist circumference

    Time frame: From baseline to after 12 months

    Measured by measuring tape at the level of the umbilicus

  14. Systolic blood pressure

    Time frame: From baseline to after 8 weeks

    Measured by automatic blood pressure cuff

  15. Systolic blood pressure

    Time frame: From baseline to after 12 months

    Measured by automatic blood pressure cuff

  16. Diastolic blood pressure

    Time frame: From baseline to after 8 weeks

    Measured by automatic blood pressure cuff

  17. Diastolic blood pressure

    Time frame: From baseline to after 12 months

    Measured by automatic blood pressure cuff

  18. Resting heart rate

    Time frame: From baseline to after 8 weeks

    Measured by automatic blood pressure cuff

  19. Resting heart rate

    Time frame: From baseline to after 12 months

    Measured by automatic blood pressure cuff

  20. Blood cholesterol

    Time frame: From baseline to after 8 weeks

    Venous blood sampling

  21. Blood cholesterol

    Time frame: From baseline to after 12 months

    Venous blood sampling

  22. LDL cholesterol

    Time frame: From baseline to after 8 weeks

    Venous blood sampling

  23. LDL cholesterol

    Time frame: From baseline to after 12 months

    Venous blood sampling

  24. HDL cholesterol

    Time frame: From baseline to after 8 weeks

    Venous blood sampling

  25. HDL cholesterol

    Time frame: From baseline to after 12 months

    Venous blood sampling

  26. Triglycerides

    Time frame: From baseline to after 8 weeks

    Venous blood sampling

  27. Triglycerides

    Time frame: From baseline to after 12 months

    Venous blood sampling

  28. Fasting glucose

    Time frame: From baseline to after 8 weeks

    Venous blood sampling

  29. Fasting glucose

    Time frame: From baseline to after 12 months

    Venous blood sampling

  30. Insulin C-peptide

    Time frame: From baseline to after 8 weeks

    Venous blood sampling

  31. Insulin C-peptide

    Time frame: From baseline to after 12 months

    Venous blood sampling

  32. Plasma glucose after oral glucose tolerance test

    Time frame: From baseline to after 8 weeks

    Venous blood sampling 120 minutes after ingesting 75 gram glucose

  33. Plasma glucose after oral glucose tolerance test

    Time frame: From baseline to after 12 months

    Venous blood sampling 120 minutes after ingesting 75 gram glucose

  34. Dietary intake

    Time frame: From baseline to after 8 weeks

    Self-reported dietary intake using electronic application

  35. Dietary intake

    Time frame: From baseline to after 12 months

    Self-reported dietary intake using electronic application

  36. Mean Daily Minutes of Moderate-to-Vigorous Physical Activity Measured by ActiGraph Accelerometer

    Time frame: 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.

  37. Mean Daily Minutes of Moderate-to-Vigorous Physical Activity Measured by ActiGraph Accelerometer

    Time frame: 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.

  38. Self-reported physical activity

    Time frame: From baseline to after 8 weeks

    International Physical Activity Questionnaire

  39. Self-reported physical activity

    Time frame: From baseline to after 12 months

    International Physical Activity Questionnaire

  40. Psychological wellbeing

    Time frame: 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.

  41. Psychological wellbeing

    Time frame: 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.

  42. Sleep quality

    Time frame: 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.

  43. Sleep quality

    Time frame: 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.

  44. Depression

    Time frame: 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.

  45. Depression

    Time frame: 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.

  46. Anxiety

    Time frame: 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.

  47. Anxiety

    Time frame: 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.

  48. Type 2 diabetes mellitus diagnosis

    Time frame: During the 12-month follow-up

    Participant-reported or measurement of HbA1c of 48 mmol/mol or above

  49. Mean Daily Step Count Measured by ActiGraph Accelerometer

    Time frame: 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.

  50. Mean Daily Sedentary Time Measured by ActiGraph Accelerometer

    Time frame: 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.

  51. Mean Daily Step Count Measured by ActiGraph Accelerometer

    Time frame: 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.

  52. Mean Daily Sedentary Time Measured by ActiGraph Accelerometer

    Time frame: 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.

Other outcomes

  1. Infant feeding method

    Time frame: 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.

  2. Adherence to time-restricted eating

    Time frame: 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

  3. Adherence to exercise training

    Time frame: During the 8-week intervention and during the 12-month follow-up

    Number of completed sessions, recorded using an electronic application

  4. Perception of intervention and follow-up

    Time frame: After 12 months

    Qualitative interviews with selected participants to explore barriers and motivators

Study contacts

Contact information is provided by the study sponsor or research team.

Beathe Sitter, PhD

CONTACT

[email protected]

+4799024180

Trine Moholdt, PhD

CONTACT

[email protected]

+4797098594

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study title

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

Acronym: TRE-HIITmoms

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

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

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

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

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