A Novel Diet Approach to Combat Gestational Diabetes

Norwegian University of Science and Technology

Status: Completed

Conditions: Diabetes, Gestational

Treatments: Behavioral: time restricted eating (TRE)

Study type: Interventional

Funder types: Other

Identifiers

NCT03803072

2018/2271

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Time restricted eating (TRE)

Experimental group

Description:

prolonging the duration of fasting between the last evening meal and the first meal of the next day

Treatment:

Behavioral: time restricted eating (TRE)

control

No Intervention group

Description:

Standard care. Will receive a booklet about physical activity recommendations and healthy eating in pregnancy