A Novel Diet Approach to Combat Gestational Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Diabetes, Gestational
• Intervention / Treatment: Behavioral: time restricted eating (TRE)

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Trine Moholdt, phd; Phone Number: 0047 97098594; Email: trine.moholdt@ntnu.no
• Study Contact Backup: Name: Kirsti Garnæs, phd

Study Locations

• Norway
  • Trondheim, Norway
    • St Olavs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Time restricted eating (TRE); prolonging the duration of fasting between the last evening meal and the first meal of the next day	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.
No Intervention: control; Standard care. Will receive a booklet about physical activity recommendations and healthy eating in pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
Change between baseline and post-intervention in fasting glucose	Post-intervention fasting glucose minus pre-intervention fasting glucose	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)	6 weeks
Change between baseline and post-intervention in fasting insulin	Circulating insulin levels	6 weeks
Change between baseline and post-intervention in postprandial insulin	Circulating insulin levels 120 minutes after ingestion of 75 g glucose.	6 weeks
Change between baseline and post-intervention blood pressure	Diastolic and systolic blood pressure	6 weeks
Change between baseline and post-intervention body mass	Body mass in kg.	6 weeks
Change in total cholesterol	Total cholesterol measured in blood	6 weeks
Change in triglycerides	Triglycerides measured in blood	6 weeks
Change in HDL cholesterol	HDL cholesterol measured in blood	6 weeks
Change in LDL cholesterol	LDL cholesterol measured in blood	6 weeks
Change in HbA1c	HbA1c measured in blood	6 weeks
Continuous glucose monitoring	Interstitial glucose measurements	6 weeks
Change between baseline and post-intervention fat mass	Fat mass in kg and percent of body mass	6 weeks
Change between baseline and post-intervention muscle mass	Muscle mass in kg	6 weeks
Change between baseline and post-intervention visceral fat area	Visceral fat area in squared cm.	6 weeks

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital
• Investigators: Study Director: Øystein Risa, phd, Department of circulation and medical imaging, NTNU

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2019
• Primary Completion (Actual): March 13, 2023
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: December 18, 2018
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Diet; Exercise therapy; Prevention and control
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: 2018/2271

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No