A Novel Diet Approach to Combat Gestational Diabetes

NCT03803072 | Completed

• 1 other identifier: 2018/2271
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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. 1.Women who have an increased risk of GDM will be able to adhere to time reduced eating during pregnancy.
2. 2.Time reduced eating will improve short-term glycemic control in pregnancy.

Conditions

Diabetes, Gestational

Keywords

Exercise therapy; Diet; Prevention and control

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• Perceived barriers to the protocol assessed with an unstructured interview

  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

  Once weekly throughout 6 weeks, on a weekday.

• Change between baseline and post-intervention in fasting glucose

  6 weeks

• Change between baseline and post-intervention in postprandial glucose

  6 weeks

• Change between baseline and post-intervention in fasting insulin

  6 weeks

Study Arms (2)

Time restricted eating (TRE)

EXPERIMENTAL

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

Behavioral: time restricted eating (TRE)

control

NO INTERVENTION

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

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.

Time restricted eating (TRE)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• habitual eating window \< 12 hours

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Øystein Risa, phd

  Department of circulation and medical imaging, NTNU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: January 14, 2019
• Study Start: January 18, 2019
• Primary Completion: March 13, 2023
• Study Completion: March 15, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)