Diabetes, GestationalNCT03803072
A Novel Diet Approach to Combat Gestational Diabetes
A study testing time restricted eating (TRE) in people with Diabetes, Gestational, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes, Gestational
- What is being tested?
- time restricted eating (TRE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNorway
- Study dates
- 18 Jan 2019to 15 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- habitual eating window < 12 hours
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Diabetes, Gestational
- Being tested
- time restricted eating (TRE)
- Keywords
- Exercise therapy, Diet, Prevention and control
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
time restricted eating (TRE)Behavioural
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 group | Role | What they receive |
|---|---|---|
| Time restricted eating (TRE) | Experimental | prolonging the duration of fasting between the last evening meal and the first meal of the next day Receives: Behavioral: time restricted eating (TRE) |
| control | No intervention | Standard care. Will receive a booklet about physical activity recommendations and healthy eating in pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average time-window for energy intake
Average daily time-window for energy intake will be registered through log books.
Measured: 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
Measured: Weekly measures throughout the 5 week period of TRE intervention
Secondary outcomes (17)
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.
Measured: 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
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.
Measured: Once weekly throughout 6 weeks, on a weekday.
Change between baseline and post-intervention in fasting glucose
Post-intervention fasting glucose minus pre-intervention fasting glucose
Measured: 6 weeks
Change between baseline and post-intervention in postprandial glucose
Blood glucose levels 120 minutes after ingestion of 75 g glucose (oral glucose tolerance test)
Measured: 6 weeks
Change between baseline and post-intervention in fasting insulin
Circulating insulin levels
Measured: 6 weeks
Change between baseline and post-intervention in postprandial insulin
Circulating insulin levels 120 minutes after ingestion of 75 g glucose.
Measured: 6 weeks
Change between baseline and post-intervention blood pressure
Diastolic and systolic blood pressure
Measured: 6 weeks
Change between baseline and post-intervention body mass
Body mass in kg.
Measured: 6 weeks
Change in total cholesterol
Total cholesterol measured in blood
Measured: 6 weeks
Change in triglycerides
Triglycerides measured in blood
Measured: 6 weeks
Change in HDL cholesterol
HDL cholesterol measured in blood
Measured: 6 weeks
Change in LDL cholesterol
LDL cholesterol measured in blood
Measured: 6 weeks
Change in HbA1c
HbA1c measured in blood
Measured: 6 weeks
Continuous glucose monitoring
Interstitial glucose measurements
Measured: 6 weeks
Change between baseline and post-intervention fat mass
Fat mass in kg and percent of body mass
Measured: 6 weeks
Change between baseline and post-intervention muscle mass
Muscle mass in kg
Measured: 6 weeks
Change between baseline and post-intervention visceral fat area
Visceral fat area in squared cm.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start18 Jan 2019
- Primary completion13 Mar 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, GestationalStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Øystein Risa, phd, Study director, Department of circulation and medical imaging, NTNU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803072
- Sponsor's protocol ID
- 2018/2271
- Status last verified
- Mar 2023
- First submitted
- 18 Dec 2018
- Last updated
- 16 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Diet Approach to Combat Gestational Diabetes
- ClinicalTrials.gov ID
- NCT03803072
- Acronym / sponsor ID
- 2018/2271
- Conditions
- Diabetes, Gestational
- Keywords
- Exercise therapy, Diet, Prevention and control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 13 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time restricted eating (TRE) | Experimental | Behavioral: time restricted eating (TRE)prolonging the duration of fasting between the last evening meal and the first meal of the next day |
| control | No intervention | –Standard care. Will receive a booklet about physical activity recommendations and healthy eating in pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- habitual eating window < 12 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Time restricted eating (TRE) |
Primary outcome
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
17 secondary outcomes
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
Subjective appetite sensations assessed by Visual Analogue Scales
Time frame: Once weekly throughout 6 weeks, on a weekday.
Change between baseline and post-intervention in fasting glucose
Time frame: 6 weeks
Change between baseline and post-intervention in postprandial glucose
Time frame: 6 weeks
Change between baseline and post-intervention in fasting insulin
Time frame: 6 weeks
Change between baseline and post-intervention in postprandial insulin
Time frame: 6 weeks
Change between baseline and post-intervention blood pressure
Time frame: 6 weeks
Change between baseline and post-intervention body mass
Time frame: 6 weeks
Change in total cholesterol
Time frame: 6 weeks
Change in triglycerides
Time frame: 6 weeks
Change in HDL cholesterol
Time frame: 6 weeks
Change in LDL cholesterol
Time frame: 6 weeks
Change in HbA1c
Time frame: 6 weeks
Continuous glucose monitoring
Time frame: 6 weeks
Change between baseline and post-intervention fat mass
Time frame: 6 weeks
Change between baseline and post-intervention muscle mass
Time frame: 6 weeks
Change between baseline and post-intervention visceral fat area
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Øystein Risa, phd study director
Department of circulation and medical imaging, NTNU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing time restricted eating (TRE) in people with Diabetes, Gestational, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.