A Novel Diet Approach to Combat Gestational Diabetes

Norwegian University of Science and Technology32 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Diabetes, Gestational

Interventions

time restricted eating (TRE)BEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

St Olavs Hospital

Trondheim, Norway

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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