Gestational Diabetes Mellitus With Baby Delivered
Conditions
Keywords
Exercise, Time-restricted eating, High-intensity interval training
Brief summary
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.
Detailed description
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
Interventions
BEHAVIORALTime-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.
Sponsors
Norwegian University of Science and Technology
St. Olavs Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak oxygen uptake | From baseline to after 8 weeks | Direct measurement of oxygen uptake during graded maximal exercise test to exhaustion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dietary intake | From baseline to after 8 weeks | Self-reported dietary intake using electronic application |
| Peak oxygen uptake | From baseline to after 12 months | Direct measurement of oxygen uptake during graded maximal exercise test to exhaustion |
| Body mass | From baseline to after 8 weeks | Estimated by bioimpedance scale |
| Fat mass | From baseline to after 8 weeks | Estimated by bioimpedance scale |
| Muscle mass | From baseline to after 8 weeks | Estimated by bioimpedance scale |
| Visceral fat area | From baseline to after 8 weeks | Estimated by bioimpedance scale |
| Bone mass | From baseline to after 8 weeks | Estimated by bioimpedance scale |
| Waist circumference | From baseline to after 8 weeks | Measured by measuring tape at the level of the umbilicus |
| Systolic blood pressure | From baseline to after 8 weeks | Measured by automatic blood pressure cuff |
| Diastolic blood pressure | From baseline to after 8 weeks | Measured by automatic blood pressure cuff |
| Resting heart rate | From baseline to after 8 weeks | Measured by automatic blood pressure cuff |
| Blood cholesterol | From baseline to after 8 weeks | Venous blood sampling |
| LDL cholesterol | From baseline to after 8 weeks | Venous blood sampling |
| HDL cholesterol | From baseline to after 8 weeks | Venous blood sampling |
| Triglycerides | From baseline to after 8 weeks | Venous blood sampling |
| Fasting glucose | From baseline to after 8 weeks | Venous blood sampling |
| Insulin C-peptide | From baseline to after 8 weeks | Venous blood sampling |
| Mean Daily Minutes of Moderate-to-Vigorous Physical Activity Measured by ActiGraph Accelerometer | 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. |
| Self-reported physical activity | From baseline to after 8 weeks | International Physical Activity Questionnaire |
| Psychological wellbeing | 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. |
| Sleep quality | 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. |
| Depression | 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. |
| Anxiety | 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. |
| Type 2 diabetes mellitus diagnosis | During the 12-month follow-up | Participant-reported or measurement of HbA1c of 48 mmol/mol or above |
| Mean Daily Step Count Measured by ActiGraph Accelerometer | 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. |
| Plasma glucose after oral glucose tolerance test | From baseline to after 8 weeks | Venous blood sampling 120 minutes after ingesting 75 gram glucose |
| Mean Daily Sedentary Time Measured by ActiGraph Accelerometer | 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. |
Countries
Norway
Contacts
CONTACTTrine Moholdt, PhD
CONTACTBeathe Sitter, PhD
PRINCIPAL_INVESTIGATORTrine Moholdt, PhD
Norwegian University of Science and Technology
Outcome results
None listed