Clinical trial NCT03803072: A Novel Diet Approach to Combat Gestational Diabetes
Official title: A Novel Diet Approach to Combat Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes, Gestational
Keywords: Exercise therapy
Diet
Prevention and control
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2019-01-14
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* habitual eating window \< 12 hours

Primary outcomes:
measure: Change in average time-window for energy intake
timeFrame: Change between baseline (pre-intervention) time-window for energy intake to average time-window for energy intake during the 5-week intervention period
measure: Weekly adherence rates for time restricted eating (TRE)
timeFrame: Weekly measures throughout the 5 week period of TRE intervention
Secondary outcomes:
measure: Perceived barriers to the protocol assessed with an unstructured interview
timeFrame: Weekly phone calls to participants in TRE group during the 5-week intervention period and after 6 weeks
measure: Subjective appetite sensations assessed by Visual Analogue Scales
timeFrame: Once weekly throughout 6 weeks, on a weekday.
measure: Change between baseline and post-intervention in fasting glucose
timeFrame: 6 weeks
measure: Change between baseline and post-intervention in postprandial glucose
timeFrame: 6 weeks
measure: Change between baseline and post-intervention in fasting insulin
timeFrame: 6 weeks
measure: Change between baseline and post-intervention in postprandial insulin
timeFrame: 6 weeks
measure: Change between baseline and post-intervention blood pressure
timeFrame: 6 weeks
measure: Change between baseline and post-intervention body mass
timeFrame: 6 weeks
measure: Change in total cholesterol
timeFrame: 6 weeks
measure: Change in triglycerides
timeFrame: 6 weeks
measure: Change in HDL cholesterol
timeFrame: 6 weeks
measure: Change in LDL cholesterol
timeFrame: 6 weeks
measure: Change in HbA1c
timeFrame: 6 weeks
measure: Continuous glucose monitoring
timeFrame: 6 weeks
measure: Change between baseline and post-intervention fat mass
timeFrame: 6 weeks
measure: Change between baseline and post-intervention muscle mass
timeFrame: 6 weeks
measure: Change between baseline and post-intervention visceral fat area
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Department of circulation and medical imaging, NTNU
name: Øystein Risa, phd
role: STUDY_DIRECTOR
References: