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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
56
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.
Department of Circulation and Medical Imaging
Trondheim, Norway
Peak oxygen uptake
Direct measurement of oxygen uptake during graded maximal exercise test to exhaustion
Time frame: From baseline to after 8 weeks
Peak oxygen uptake
Direct measurement of oxygen uptake during graded maximal exercise test to exhaustion
Time frame: From baseline to after 12 months
Body mass
Estimated by bioimpedance scale
Time frame: From baseline to after 8 weeks
Body mass
Estimated by bioimpedance scale
Time frame: From baseline to after 12 months
Fat mass
Estimated by bioimpedance scale
Time frame: From baseline to after 8 weeks
Fat mass
Estimated by bioimpedance scale
Time frame: From baseline to after 12 months
Muscle mass
Estimated by bioimpedance scale
Time frame: From baseline to after 8 weeks
Muscle mass
Estimated by bioimpedance scale
Time frame: From baseline to after 12 months
Visceral fat area
Estimated by bioimpedance scale
Time frame: From baseline to after 8 weeks
Visceral fat area
Estimated by bioimpedance scale
Time frame: From baseline to after 12 months
Bone mass
Estimated by bioimpedance scale
Time frame: From baseline to after 8 weeks
Bone mass
Estimated by bioimpedance scale
Time frame: From baseline to after 12 months
Waist circumference
Measured by measuring tape at the level of the umbilicus
Time frame: From baseline to after 8 weeks
Waist circumference
Measured by measuring tape at the level of the umbilicus
Time frame: From baseline to after 12 months
Systolic blood pressure
Measured by automatic blood pressure cuff
Time frame: From baseline to after 8 weeks
Systolic blood pressure
Measured by automatic blood pressure cuff
Time frame: From baseline to after 12 months
Diastolic blood pressure
Measured by automatic blood pressure cuff
Time frame: From baseline to after 8 weeks
Diastolic blood pressure
Measured by automatic blood pressure cuff
Time frame: From baseline to after 12 months
Resting heart rate
Measured by automatic blood pressure cuff
Time frame: From baseline to after 8 weeks
Resting heart rate
Measured by automatic blood pressure cuff
Time frame: From baseline to after 12 months
Blood cholesterol
Venous blood sampling
Time frame: From baseline to after 8 weeks
Blood cholesterol
Venous blood sampling
Time frame: From baseline to after 12 months
LDL cholesterol
Venous blood sampling
Time frame: From baseline to after 8 weeks
LDL cholesterol
Venous blood sampling
Time frame: From baseline to after 12 months
HDL cholesterol
Venous blood sampling
Time frame: From baseline to after 8 weeks
HDL cholesterol
Venous blood sampling
Time frame: From baseline to after 12 months
Triglycerides
Venous blood sampling
Time frame: From baseline to after 8 weeks
Triglycerides
Venous blood sampling
Time frame: From baseline to after 12 months
Fasting glucose
Venous blood sampling
Time frame: From baseline to after 8 weeks
Fasting glucose
Venous blood sampling
Time frame: From baseline to after 12 months
Insulin C-peptide
Venous blood sampling
Time frame: From baseline to after 8 weeks
Insulin C-peptide
Venous blood sampling
Time frame: From baseline to after 12 months
Plasma glucose after oral glucose tolerance test
Venous blood sampling 120 minutes after ingesting 75 gram glucose
Time frame: From baseline to after 8 weeks
Plasma glucose after oral glucose tolerance test
Venous blood sampling 120 minutes after ingesting 75 gram glucose
Time frame: From baseline to after 12 months
Dietary intake
Self-reported dietary intake using electronic application
Time frame: From baseline to after 8 weeks
Dietary intake
Self-reported dietary intake using electronic application
Time frame: From baseline to after 12 months
Mean Daily Minutes of Moderate-to-Vigorous Physical Activity Measured by ActiGraph Accelerometer
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.
Time frame: From baseline to after 8 weeks
Mean Daily Minutes of Moderate-to-Vigorous Physical Activity Measured by ActiGraph Accelerometer
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.
Time frame: From baseline to after 12 months
Self-reported physical activity
International Physical Activity Questionnaire
Time frame: From baseline to after 8 weeks
Self-reported physical activity
International Physical Activity Questionnaire
Time frame: From baseline to after 12 months
Psychological wellbeing
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.
Time frame: From baseline to after 8 weeks
Psychological wellbeing
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.
Time frame: From baseline to after 12 months
Sleep quality
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.
Time frame: From baseline to after 8 weeks
Sleep quality
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.
Time frame: From baseline to after 12 months
Depression
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.
Time frame: From baseline to 8 weeks
Depression
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.
Time frame: From baseline to after 12 months
Anxiety
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.
Time frame: From baseline to after 8 weeks
Anxiety
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.
Time frame: From baseline to after 12 months
Type 2 diabetes mellitus diagnosis
Participant-reported or measurement of HbA1c of 48 mmol/mol or above
Time frame: During the 12-month follow-up
Mean Daily Step Count Measured by ActiGraph Accelerometer
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.
Time frame: From baseline to after 8 weeks
Mean Daily Sedentary Time Measured by ActiGraph Accelerometer
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.
Time frame: At baseline and after 8 weeks
Mean Daily Step Count Measured by ActiGraph Accelerometer
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.
Time frame: From baseline to after 12 months
Mean Daily Sedentary Time Measured by ActiGraph Accelerometer
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.
Time frame: From baseline to after 12 months
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