A Novel Diet Approach to Combat Gestational Diabetes

• ClinicalTrials.gov Identifier: NCT03803072
• Recruitment Status: Recruiting
• First Posted: January 14, 2019
• Last Update Posted: November 10, 2021
• Sponsor: Norwegian University of Science and Technology
• Collaborator: St. Olavs Hospital
• Information provided by (Responsible Party): Norwegian University of Science and Technology

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes, Gestational	Behavioral: time restricted eating (TRE)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Novel Diet Approach to Combat Gestational Diabetes
• Actual Study Start Date: January 18, 2019
• Estimated Primary Completion Date: May 1, 2022
• Estimated Study Completion Date: May 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in average time-window for energy intake [ 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 ]
   Average daily time-window for energy intake will be registered through log books.
2. Weekly adherence rates for time restricted eating (TRE) [ Time Frame: Weekly measures throughout the 5 week period of TRE intervention ]
   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

Secondary Outcome Measures :

1. Perceived barriers to the protocol assessed with an unstructured interview [ Time Frame: Weekly phone calls to participants in TRE group during the 5-week intervention period and after 6 weeks ]
   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.
2. Subjective appetite sensations assessed by Visual Analogue Scales [ Time Frame: Once weekly throughout 6 weeks, on a weekday. ]
   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.
3. Change between baseline and post-intervention in fasting glucose [ Time Frame: 6 weeks ]
   Post-intervention fasting glucose minus pre-intervention fasting glucose
4. Change between baseline and post-intervention in postprandial glucose [ Time Frame: 6 weeks ]
   Blood glucose levels 120 minutes after ingestion of 75 g glucose (oral glucose tolerance test)
5. Change between baseline and post-intervention in fasting insulin [ Time Frame: 6 weeks ]
   Circulating insulin levels
6. Change between baseline and post-intervention in postprandial insulin [ Time Frame: 6 weeks ]
   Circulating insulin levels 120 minutes after ingestion of 75 g glucose.
7. Change between baseline and post-intervention blood pressure [ Time Frame: 6 weeks ]
   Diastolic and systolic blood pressure
8. Change between baseline and post-intervention body mass [ Time Frame: 6 weeks ]
   Body mass in kg.
9. Change in total cholesterol [ Time Frame: 6 weeks ]
   Total cholesterol measured in blood
10. Change in triglycerides [ Time Frame: 6 weeks ]
    Triglycerides measured in blood
11. Change in HDL cholesterol [ Time Frame: 6 weeks ]
    HDL cholesterol measured in blood
12. Change in LDL cholesterol [ Time Frame: 6 weeks ]
    LDL cholesterol measured in blood
13. Change in HbA1c [ Time Frame: 6 weeks ]
    HbA1c measured in blood
14. Continuous glucose monitoring [ Time Frame: 6 weeks ]
    Interstitial glucose measurements
15. Change between baseline and post-intervention fat mass [ Time Frame: 6 weeks ]
    Fat mass in kg and percent of body mass
16. Change between baseline and post-intervention muscle mass [ Time Frame: 6 weeks ]
    Muscle mass in kg
17. Change between baseline and post-intervention visceral fat area [ Time Frame: 6 weeks ]
    Visceral fat area in squared cm.

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Trine Moholdt, phd; 0047 97098594; trine.moholdt@ntnu.no

Contact: Kirsti Garnæs, phd

Locations

Norway

St Olavs Hospital; Recruiting

Trondheim, Norway

Contact: Ola Berger, phd

Sponsors and Collaborators

Norwegian University of Science and Technology

St. Olavs Hospital

Investigators

• Study Director: Øystein Risa, phd; Department of circulation and medical imaging, NTNU

More Information

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT03803072
• Other Study ID Numbers: 2018/2271
• First Posted: January 14, 2019
• Last Update Posted: November 10, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:

Exercise therapy; Diet; Prevention and control

Additional relevant MeSH terms:

Diabetes, Gestational; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications