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A Novel Diet Approach to Combat Gestational Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803072
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : October 31, 2019
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE December 18, 2018
First Posted Date  ICMJE January 14, 2019
Last Update Posted Date October 31, 2019
Actual Study Start Date  ICMJE January 18, 2019
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2019)
  • 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.
  • 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.
  • Change between baseline and post-intervention in fasting glucose [ Time Frame: 6 weeks ]
    Post-intervention fasting glucose minus pre-intervention fasting glucose
  • 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)
  • Change between baseline and post-intervention in fasting insulin [ Time Frame: 6 weeks ]
    Circulating insulin levels
  • Change between baseline and post-intervention in postprandial insulin [ Time Frame: 6 weeks ]
    Circulating insulin levels 120 minutes after ingestion of 75 g glucose.
  • Change between baseline and post-intervention blood pressure [ Time Frame: 6 weeks ]
    Diastolic and systolic blood pressure
  • Change between baseline and post-intervention body mass [ Time Frame: 6 weeks ]
    Body mass in kg.
  • Change in total cholesterol [ Time Frame: 6 weeks ]
    Total cholesterol measured in blood
  • Change in triglycerides [ Time Frame: 6 weeks ]
    Triglycerides measured in blood
  • Change in HDL cholesterol [ Time Frame: 6 weeks ]
    HDL cholesterol measured in blood
  • Change in LDL cholesterol [ Time Frame: 6 weeks ]
    LDL cholesterol measured in blood
  • Change in HbA1c [ Time Frame: 6 weeks ]
    HbA1c measured in blood
  • Continuous glucose monitoring [ Time Frame: 6 weeks ]
    Interstitial glucose measurements
  • Change between baseline and post-intervention fat mass [ Time Frame: 6 weeks ]
    Fat mass in kg and percent of body mass
  • Change between baseline and post-intervention muscle mass [ Time Frame: 6 weeks ]
    Muscle mass in kg
  • Change between baseline and post-intervention visceral fat area [ Time Frame: 6 weeks ]
    Visceral fat area in squared cm.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
  • 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.
  • 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.
  • Change between baseline and post-intervention in fasting glucose [ Time Frame: 6 weeks ]
    Post-intervention fasting glucose minus pre-intervention fasting glucose
  • 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)
  • Change between baseline and post-intervention in fasting insulin [ Time Frame: 6 weeks ]
    Circulating insulin levels
  • Change between baseline and post-intervention in postprandial insulin [ Time Frame: 6 weeks ]
    Circulating insulin levels 120 minutes after ingestion of 75 g glucose.
  • Change between baseline and post-intervention blood pressure [ Time Frame: 6 weeks ]
    Diastolic and systolic blood pressure
  • Change between baseline and post-intervention body mass [ Time Frame: 6 weeks ]
    Body mass in kg.
  • Change in total cholesterol [ Time Frame: 6 weeks ]
    Total cholesterol measured in blood
  • Change in triglycerides [ Time Frame: 6 weeks ]
    Triglycerids measured in blood
  • Change in HDL cholesterol [ Time Frame: 6 weeks ]
    HDL cholesterol measured in blood
  • Change in LDL cholesterol [ Time Frame: 6 weeks ]
    LDL cholesterol measured in blood
  • Change in HbA1c [ Time Frame: 6 weeks ]
    HbA1c measured in blood
  • Continuous glucose monitoring [ Time Frame: 6 weeks ]
    Interstitial glucose measurements
  • Change between baseline and post-intervention fat mass [ Time Frame: 6 weeks ]
    Fat mass in kg and percent of body mass
  • Change between baseline and post-intervention muscle mass [ Time Frame: 6 weeks ]
    Muscle mass in kg
  • Change between baseline and post-intervention visceral fat area [ Time Frame: 6 weeks ]
    Visceral fat area in squared cm.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Novel Diet Approach to Combat Gestational Diabetes
Official Title  ICMJE A Novel Diet Approach to Combat Gestational Diabetes
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Diabetes, Gestational
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Time restricted eating (TRE)
    prolonging the duration of fasting between the last evening meal and the first meal of the next day
    Intervention: Behavioral: time restricted eating (TRE)
  • No Intervention: control
    Standard care. Will receive a booklet about physical activity recommendations and healthy eating in pregnancy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 10, 2019)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2020
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Trine Moholdt, phd 0047 97098594 trine.moholdt@ntnu.no
Contact: Kirsti Garnæs, phd
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03803072
Other Study ID Numbers  ICMJE 2018/2271
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE St. Olavs Hospital
Investigators  ICMJE
Study Director: Øystein Risa, phd Department of circulation and medical imaging, NTNU
PRS Account Norwegian University of Science and Technology
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP