A Novel Diet Approach to Combat Gestational Diabetes

NCT ID: NCT03803072

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-18
• Study Completion Date: 2023-03-15

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.

Conditions

Diabetes, Gestational

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Time restricted eating (TRE)

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

Group Type: EXPERIMENTAL

time restricted eating (TRE)

Intervention Type: 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.

control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Øystein Risa, phd

Role: STUDY_DIRECTOR

Department of circulation and medical imaging, NTNU

Locations

St Olavs Hospital

Trondheim, , Norway

Countries

Norway

Other Identifiers

2018/2271

Identifier Type: -

Identifier Source: org_study_id