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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorNorwegian University of Science and Technology

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Peak oxygen uptake

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

Time frame
From baseline to after 8 weeks

Secondary outcomes

1

Peak oxygen uptake

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

Time frame
From baseline to after 12 months
2

Body mass

Estimated by bioimpedance scale

Time frame
From baseline to after 8 weeks
3

Body mass

Estimated by bioimpedance scale

Time frame
From baseline to after 12 months
4

Fat mass

Estimated by bioimpedance scale

Time frame
From baseline to after 8 weeks

Other outcomes

1

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.

Time frame
Baseline, 8 weeks, and after 12 months
2

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

Time frame
Baseline, after 8 weeks and after 12 months
3

Adherence to exercise training

Number of completed sessions, recorded using an electronic application

Time frame
During the 8-week intervention and during the 12-month follow-up
4

Perception of intervention and follow-up

Qualitative interviews with selected participants to explore barriers and motivators

Time frame
After 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: