An interventional study of time restricted eating (TRE) in Diabetes, Gestational, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-16.
Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Prevention
There is an urgent need to implement novel diet approaches to combat the increasing rates of gestational diabetes mellitus (GDM). The primary aim of this study is to establish the feasibility of time-restricted eating in pregnancy, to prepare for future larger controlled trials in this research project to determine the efficacy of time-restricted eating in women at risk of GDM. Expectations:
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's enrollment of 32 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
prolonging the duration of fasting between the last evening meal and the first meal of the next day
Behavioral: time restricted eating (TRE)
Standard care. Will receive a booklet about physical activity recommendations and healthy eating in pregnancy
Participants will attend a face-to-face meeting with the researchers at the last day of the first week of data collection (habitual diet and physical activity period) where they will be counselled to consume all food and fluid within a 8-10 h time window of their choice starting no later than 09.00 h for five weeks. During the intervention period, they will be counselled by weekly phone calls to provide encouragement, support and monitoring to improve adherence to the TRE window.
Change in average time-window for energy intake
Average daily time-window for energy intake will be registered through log books.
Time frame: Change between baseline (pre-intervention) time-window for energy intake to average time-window for energy intake during the 5-week intervention period
Weekly adherence rates for time restricted eating (TRE)
The number of days per week that the participants are able to adhere to TRE, as calculated as weekly average of days with a time-window ≤ 10 hours
Time frame: Weekly measures throughout the 5 week period of TRE intervention
Perceived barriers to the protocol assessed with an unstructured interview
Participants will be asked about which barriers they perceived as challenging regarding keeping to a TRE schedule and if they have strategies to overcome these barriers.
Time frame: Weekly phone calls to participants in TRE group during the 5-week intervention period and after 6 weeks
Subjective appetite sensations assessed by Visual Analogue Scales
Paper line scales 100 mm on scales for Hunger ("How hungry are you": From "Not at all" = 0 on the scale to "Extremely. As hungry as I have ever felt" =100 on the scale, Fullness (From "Not at all" = 0 on the scale to "Extremely. As full as I have ever felt" = 100 on the scale, Satiety ("How satiated are you" From "Not at all" =0 on the scale to "Extremely" =100 on the scale, Desire to eat ("How strong is your desire to eat" From "Very weak. Extremely low" = 0 on the scale to "Very strong. Extremely high" = 100 on the scale and Prospective consumption (quantity) ("How much do you think you could (or would want to) eat right now?" From "Nothing at all" = 0 on the scale to "A very large amount" = 100 on the scale. Scales will be filled in in the morning, before dinner and at bedtime.
Time frame: Once weekly throughout 6 weeks, on a weekday.
Change between baseline and post-intervention in fasting glucose
Post-intervention fasting glucose minus pre-intervention fasting glucose
Time frame: 6 weeks
Change between baseline and post-intervention in postprandial glucose
Blood glucose levels 120 minutes after ingestion of 75 g glucose (oral glucose tolerance test)
Time frame: 6 weeks
Change between baseline and post-intervention in fasting insulin
Circulating insulin levels
Time frame: 6 weeks
Change between baseline and post-intervention in postprandial insulin
Circulating insulin levels 120 minutes after ingestion of 75 g glucose.
Time frame: 6 weeks
Change between baseline and post-intervention blood pressure
Diastolic and systolic blood pressure
Time frame: 6 weeks
Change between baseline and post-intervention body mass
Body mass in kg.
Time frame: 6 weeks
Change in total cholesterol
Total cholesterol measured in blood
Time frame: 6 weeks
Change in triglycerides
Triglycerides measured in blood
Time frame: 6 weeks
Change in HDL cholesterol
HDL cholesterol measured in blood
Time frame: 6 weeks
Change in LDL cholesterol
LDL cholesterol measured in blood
Time frame: 6 weeks
Change in HbA1c
HbA1c measured in blood
Time frame: 6 weeks
Continuous glucose monitoring
Interstitial glucose measurements
Time frame: 6 weeks
Change between baseline and post-intervention fat mass
Fat mass in kg and percent of body mass
Time frame: 6 weeks
Change between baseline and post-intervention muscle mass
Muscle mass in kg
Time frame: 6 weeks
Change between baseline and post-intervention visceral fat area
Visceral fat area in squared cm.
Time frame: 6 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Norwegian University of Science and Technology