A Novel Diet Approach to Combat Gestational Diabetes
- Conditions
- Diabetes, Gestational
- Interventions
- Behavioral: time restricted eating (TRE)
- Registration Number
- NCT03803072
- Lead Sponsor
- Norwegian University of Science and Technology
- Brief Summary
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:
1. Women who have an increased risk of GDM will be able to adhere to time reduced eating during pregnancy.
2. Time reduced eating will improve short-term glycemic control in pregnancy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 32
- carrying one singleton live foetus
- in pregnancy week 12-30
- having at least one risk factor for gestational diabetes mellitus (GDM) according to Norwegian guidelines for GDM screening: pre-pregnancy BMI > 25 kg/m2, GDM in previous pregnancy, primiparae aged > 25 years, first degree relative with diabetes mellitus, Asian or African ethnicity, previous delivery of new-born > 4.5 kg
- understand written and spoken Norwegian language
- habitual eating window < 12 hours
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Time restricted eating (TRE) time restricted eating (TRE) prolonging the duration of fasting between the last evening meal and the first meal of the next day
- Primary Outcome Measures
Name Time Method Weekly adherence rates for time restricted eating (TRE) Weekly measures throughout the 5 week period of TRE intervention 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
Change in average time-window for energy intake Change between baseline (pre-intervention) time-window for energy intake to average time-window for energy intake during the 5-week intervention period Average daily time-window for energy intake will be registered through log books.
- Secondary Outcome Measures
Name Time Method Change between baseline and post-intervention in fasting glucose 6 weeks Post-intervention fasting glucose minus pre-intervention fasting glucose
Change in triglycerides 6 weeks Triglycerides measured in blood
Change in LDL cholesterol 6 weeks LDL cholesterol measured in blood
Change in HbA1c 6 weeks HbA1c measured in blood
Continuous glucose monitoring 6 weeks Interstitial glucose measurements
Change between baseline and post-intervention muscle mass 6 weeks Muscle mass in kg
Perceived barriers to the protocol assessed with an unstructured interview Weekly phone calls to participants in TRE group during the 5-week intervention period and after 6 weeks 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.
Change between baseline and post-intervention in postprandial glucose 6 weeks Blood glucose levels 120 minutes after ingestion of 75 g glucose (oral glucose tolerance test)
Change between baseline and post-intervention in fasting insulin 6 weeks Circulating insulin levels
Change between baseline and post-intervention in postprandial insulin 6 weeks Circulating insulin levels 120 minutes after ingestion of 75 g glucose.
Change between baseline and post-intervention blood pressure 6 weeks Diastolic and systolic blood pressure
Change in total cholesterol 6 weeks Total cholesterol measured in blood
Change in HDL cholesterol 6 weeks HDL cholesterol measured in blood
Change between baseline and post-intervention visceral fat area 6 weeks Visceral fat area in squared cm.
Subjective appetite sensations assessed by Visual Analogue Scales Once weekly throughout 6 weeks, on a weekday. 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.
Change between baseline and post-intervention body mass 6 weeks Body mass in kg.
Change between baseline and post-intervention fat mass 6 weeks Fat mass in kg and percent of body mass
Trial Locations
- Locations (1)
St Olavs Hospital
🇳🇴Trondheim, Norway