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Completed

NCT Number: NCT03803072

A Novel Diet Approach to Combat Gestational Diabetes

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St Olavs Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 14, 2019
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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