About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Time-restricted eating and exercise
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Peak oxygen uptake
Direct measurement of oxygen uptake during graded maximal exercise test to exhaustion
Secondary outcomes
Peak oxygen uptake
Direct measurement of oxygen uptake during graded maximal exercise test to exhaustion
Body mass
Estimated by bioimpedance scale
Body mass
Estimated by bioimpedance scale
Fat mass
Estimated by bioimpedance scale
Other outcomes
Infant feeding method
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.
Adherence to time-restricted eating
Time-frame for daily energy intake, reported as average and percentage of participants who adhere to \< 10 hours daily energy intake window
Adherence to exercise training
Number of completed sessions, recorded using an electronic application
Perception of intervention and follow-up
Qualitative interviews with selected participants to explore barriers and motivators
Sponsors and contacts
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Norwegian University of Science and Technology
Lead sponsor
St. Olavs Hospital
Collaborator
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