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A Novel Diet Approach to Combat Gestational Diabetes

Primary Purpose

Diabetes, Gestational

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
time restricted eating (TRE)
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes, Gestational focused on measuring Exercise therapy, Diet, Prevention and control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • St Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Time restricted eating (TRE)

control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in average time-window for energy intake
Average daily time-window for energy intake will be registered through log books.
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

Secondary Outcome Measures

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.
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.
Change between baseline and post-intervention in fasting glucose
Post-intervention fasting glucose minus pre-intervention fasting glucose
Change between baseline and post-intervention in postprandial glucose
Blood glucose levels 120 minutes after ingestion of 75 g glucose (oral glucose tolerance test)
Change between baseline and post-intervention in fasting insulin
Circulating insulin levels
Change between baseline and post-intervention in postprandial insulin
Circulating insulin levels 120 minutes after ingestion of 75 g glucose.
Change between baseline and post-intervention blood pressure
Diastolic and systolic blood pressure
Change between baseline and post-intervention body mass
Body mass in kg.
Change in total cholesterol
Total cholesterol measured in blood
Change in triglycerides
Triglycerides measured in blood
Change in HDL cholesterol
HDL cholesterol measured in blood
Change in LDL cholesterol
LDL cholesterol measured in blood
Change in HbA1c
HbA1c measured in blood
Continuous glucose monitoring
Interstitial glucose measurements
Change between baseline and post-intervention fat mass
Fat mass in kg and percent of body mass
Change between baseline and post-intervention muscle mass
Muscle mass in kg
Change between baseline and post-intervention visceral fat area
Visceral fat area in squared cm.

Full Information

First Posted
December 18, 2018
Last Updated
March 15, 2023
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03803072
Brief Title
A Novel Diet Approach to Combat Gestational Diabetes
Official Title
A Novel Diet Approach to Combat Gestational Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 18, 2019 (Actual)
Primary Completion Date
March 13, 2023 (Actual)
Study Completion Date
March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital

4. Oversight

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Gestational
Keywords
Exercise therapy, Diet, Prevention and control

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Time restricted eating (TRE)
Arm Type
Experimental
Arm Description
prolonging the duration of fasting between the last evening meal and the first meal of the next day
Arm Title
control
Arm Type
No Intervention
Arm Description
Standard care. Will receive a booklet about physical activity recommendations and healthy eating in pregnancy
Intervention Type
Behavioral
Intervention Name(s)
time restricted eating (TRE)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in average time-window for energy intake
Description
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
Title
Weekly adherence rates for time restricted eating (TRE)
Description
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 Outcome Measure Information:
Title
Perceived barriers to the protocol assessed with an unstructured interview
Description
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
Title
Subjective appetite sensations assessed by Visual Analogue Scales
Description
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.
Title
Change between baseline and post-intervention in fasting glucose
Description
Post-intervention fasting glucose minus pre-intervention fasting glucose
Time Frame
6 weeks
Title
Change between baseline and post-intervention in postprandial glucose
Description
Blood glucose levels 120 minutes after ingestion of 75 g glucose (oral glucose tolerance test)
Time Frame
6 weeks
Title
Change between baseline and post-intervention in fasting insulin
Description
Circulating insulin levels
Time Frame
6 weeks
Title
Change between baseline and post-intervention in postprandial insulin
Description
Circulating insulin levels 120 minutes after ingestion of 75 g glucose.
Time Frame
6 weeks
Title
Change between baseline and post-intervention blood pressure
Description
Diastolic and systolic blood pressure
Time Frame
6 weeks
Title
Change between baseline and post-intervention body mass
Description
Body mass in kg.
Time Frame
6 weeks
Title
Change in total cholesterol
Description
Total cholesterol measured in blood
Time Frame
6 weeks
Title
Change in triglycerides
Description
Triglycerides measured in blood
Time Frame
6 weeks
Title
Change in HDL cholesterol
Description
HDL cholesterol measured in blood
Time Frame
6 weeks
Title
Change in LDL cholesterol
Description
LDL cholesterol measured in blood
Time Frame
6 weeks
Title
Change in HbA1c
Description
HbA1c measured in blood
Time Frame
6 weeks
Title
Continuous glucose monitoring
Description
Interstitial glucose measurements
Time Frame
6 weeks
Title
Change between baseline and post-intervention fat mass
Description
Fat mass in kg and percent of body mass
Time Frame
6 weeks
Title
Change between baseline and post-intervention muscle mass
Description
Muscle mass in kg
Time Frame
6 weeks
Title
Change between baseline and post-intervention visceral fat area
Description
Visceral fat area in squared cm.
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Øystein Risa, phd
Organizational Affiliation
Department of circulation and medical imaging, NTNU
Official's Role
Study Director
Facility Information:
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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A Novel Diet Approach to Combat Gestational Diabetes

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