A Novel Diet Approach to Combat Gestational Diabetes

Diabetes, Gestational Clinical Trial

Official title:

A Novel Diet Approach to Combat Gestational Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03803072
• Other study ID #: 2018/2271
• Status: Completed
• Phase: N/A
• Start date: January 18, 2019
• Est. completion date: March 15, 2023

Study information

• Verified date: March 2023
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 15, 2023
• Est. primary completion date: March 13, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational

Intervention

Behavioral:
• time restricted eating (TRE)
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.

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in average time-window for energy intake	Average daily time-window for energy intake will be registered through log books.	Change between baseline (pre-intervention) time-window for energy intake to average time-window for energy intake during the 5-week intervention period
Primary	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	Weekly measures throughout the 5 week period of TRE intervention
Secondary	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.	Weekly phone calls to participants in TRE group during the 5-week intervention period and after 6 weeks
Secondary	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.	Once weekly throughout 6 weeks, on a weekday.
Secondary	Change between baseline and post-intervention in fasting glucose	Post-intervention fasting glucose minus pre-intervention fasting glucose	6 weeks
Secondary	Change between baseline and post-intervention in postprandial glucose	Blood glucose levels 120 minutes after ingestion of 75 g glucose (oral glucose tolerance test)	6 weeks
Secondary	Change between baseline and post-intervention in fasting insulin	Circulating insulin levels	6 weeks
Secondary	Change between baseline and post-intervention in postprandial insulin	Circulating insulin levels 120 minutes after ingestion of 75 g glucose.	6 weeks
Secondary	Change between baseline and post-intervention blood pressure	Diastolic and systolic blood pressure	6 weeks
Secondary	Change between baseline and post-intervention body mass	Body mass in kg.	6 weeks
Secondary	Change in total cholesterol	Total cholesterol measured in blood	6 weeks
Secondary	Change in triglycerides	Triglycerides measured in blood	6 weeks
Secondary	Change in HDL cholesterol	HDL cholesterol measured in blood	6 weeks
Secondary	Change in LDL cholesterol	LDL cholesterol measured in blood	6 weeks
Secondary	Change in HbA1c	HbA1c measured in blood	6 weeks
Secondary	Continuous glucose monitoring	Interstitial glucose measurements	6 weeks
Secondary	Change between baseline and post-intervention fat mass	Fat mass in kg and percent of body mass	6 weeks
Secondary	Change between baseline and post-intervention muscle mass	Muscle mass in kg	6 weeks
Secondary	Change between baseline and post-intervention visceral fat area	Visceral fat area in squared cm.	6 weeks