Back to resultsPreconception Lifestyle Interventions to Improve Future Metabolic Health (Before the Beginning)
Primary Purpose
Gestational Diabetes
Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
time-restricted eating
high intensity exercise
Standard Care
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Diabetes focused on measuring Diet therapy, Exercise therapy
Eligibility Criteria
Inclusion Criteria:
- contemplating pregnancy within the next six months
- At least one of the following criteria: BMI ≥ 25 < 40 kg/m2, gestational diabetes in a previous pregnancy, previous infant > 4.5 kg, fasting plasma glucose > 5.3 mmol/L, or Non-European ethnicity
Exclusion Criteria:
- On-going pregnancy
- Trying to conceive ≥ 6 cycles at study entry
- Known diabetes (type 1 or 2)
- Shift work that includes night shifts > 2 days per week
- Previous hyperemesis
- Known cardiovascular diseases
- High intensity exercise ≥ 2 hours/week the last 3 months
- Habitual eating window ≤ 12 hours
Sites / Locations
- St Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
diet + training
controls
Arm Description
Outcomes
Primary Outcome Measures
Plasma glucose concentration
Plasma glucose concentration after 2 h oral glucose tolerance testing (75 g glucose)
Secondary Outcome Measures
Plasma glucose concentration
Plasma glucose concentration after 2 h oral glucose tolerance testing (75 g glucose)
HbA1c
Measured in the maternal blood
Total cholesterol
Measured in the maternal blood
Triglycerides
Measured in the maternal blood
High density lipoprotein cholesterol
Measured in the maternal blood
Low density lipoprotein cholesterol
Measured in the maternal blood
Low density cholesterol
Measured in the maternal blood
Glucose
Measured in the blood
Insulin
Measured in the blood
Cytokines
Measured in the blood, a panel of 27 cytokines of relevance for inflammatory status (Bio-Plex Pro Human Cytokine 27-plex Assay)
Adipokines (Adiponectin, Leptin, Ghrelin)
Measured in the maternal blood
Homocysteine
Measured in the maternal blood
Insulin sensitivity
Insulin sensitivity estimated by homeostatic model assessment for insulin resistance (fasting serum insulin concentration (μU/mL) x fasting plasma glucose levels (mmol/L)/22.5)
Total body mass
Estimated using InBody720 bioimpedance scale.
Fat mass
Estimated using InBody720 bioimpedance scale.
Muscle mass
Estimated using InBody720 bioimpedance scale.
Visceral fat area
Estimated using InBody720 bioimpedance scale.
Continuous glucose monitoring
Continuous glucose monitoring using Freestyle Libre (Abbott Diabetes Care), worn for 14 days.
Cardiorespiratory fitness
Peak oxygen uptake at a maximum effort exercise test, measured in L/min using Metalyzer.
Blood pressure
Systolic - and diastolic blood pressure (in mmHg) will be measured in the seated position after 15 minutes of rest with an automatic blood pressure device (Welch Allyn, Germany) three times with one minute intervals, in left arm (average of three measurement).
Measured physical activity
Measured by SenseWear activity monitor, worn for 7 days.
Measured physical activity
Measured by Amazfit GTS smartwatch
Diet intake
Online food diary (Lifesum app), 4-day registration (one weekend day and three weekdays=
Self-reported physical activity
International Physical Activity Questionnaire
Sleep
Self-reported: Pittsburgh Sleep Quality Index
Chronotype
Self-reported: Hornestberg Morningness Eveningness Questionnaire
Psychological general well being
Psychological general well being index (PGWBI)
Time to pregnancy
Self-reported
Psychological well-being
Self-reported: Psychological General Well Being Index
Birth weight (infant)
From hospital record
Birth length (infant)
From hospital record
Head circumference of infant
From hospital record
Apgar score
From hospital record
ICU admission
From hospital record
Congenital malformation
From hospital record
Gestational age at birth
From hospital record
Length of stay at hospital
From hospital record
Blood pressure (Infant)
Blood pressure (systolic - and diastolic)
Cardiac function (Infant)
Ultrasound echocardiography
Blood flow and myocardial function will be measured using mechanical wave imaging (MWI).
Infant total body mass
Estimated using impedance measurements (BioScan tough i8-nano)
Infant muscle mass
Estimated using impedance measurements (BioScan tough i8-nano)
Infant fat mass
Estimated using impedance measurements (BioScan tough i8-nano)
Infant hydration status
Estimated using impedance measurements (BioScan tough i8-nano)
Infant bone mass
Estimated using impedance measurements (BioScan tough i8-nano)
Full Information
NCT ID
NCT04585581
First Posted
September 25, 2020
Last Updated
July 4, 2023
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04585581
Brief Title
Preconception Lifestyle Interventions to Improve Future Metabolic Health (Before the Beginning)
Official Title
Before the Beginning: Preconception Lifestyle Interventions to Improve Future Metabolic Health
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 6, 2020 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to investigate whether the combination of high intensity exercise and time restricted eating before and during pregnancy can reduce the risk of hyperglycaemia during pregnancy.
Detailed Description
Women who are planning a pregnancy will be recruited into a parallel groups randomised controlled trial where the intervention will consist of high intensity training and time-restricted eating. The intervention will continue throughout pregnancy. The investigators will assess whether this lifestyle intervention can effect maternal and offspring cardiometabolic health.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
Diet therapy, Exercise therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
167 (Actual)
8. Arms, Groups, and Interventions
Arm Title
diet + training
Arm Type
Experimental
Arm Title
controls
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
time-restricted eating
Intervention Description
Participants will be asked to limit the time-window for their daily energy intake to a maximum of 10 hours.
Intervention Type
Behavioral
Intervention Name(s)
high intensity exercise
Intervention Description
Participants will be encouraged to exercise with high intensity 2-3 times per week
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Standard clinical care
Primary Outcome Measure Information:
Title
Plasma glucose concentration
Description
Plasma glucose concentration after 2 h oral glucose tolerance testing (75 g glucose)
Time Frame
Gestational week 28
Secondary Outcome Measure Information:
Title
Plasma glucose concentration
Description
Plasma glucose concentration after 2 h oral glucose tolerance testing (75 g glucose)
Time Frame
Gestational week 12
Title
HbA1c
Description
Measured in the maternal blood
Time Frame
Baseline, intervention week 8, gestational week 12 and 28
Title
Total cholesterol
Description
Measured in the maternal blood
Time Frame
Baseline, intervention week 8, gestational week 12 and 28
Title
Triglycerides
Description
Measured in the maternal blood
Time Frame
Baseline, intervention week 8, gestational week 12 and 28
Title
High density lipoprotein cholesterol
Description
Measured in the maternal blood
Time Frame
Baseline, intervention week 8, gestational week 12 and 28
Title
Low density lipoprotein cholesterol
Description
Measured in the maternal blood
Time Frame
Baseline, intervention week 8, gestational week 12 and 28
Title
Low density cholesterol
Description
Measured in the maternal blood
Time Frame
Baseline, intervention week 8, gestational week 12 and 28
Title
Glucose
Description
Measured in the blood
Time Frame
Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
Title
Insulin
Description
Measured in the blood
Time Frame
Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
Title
Cytokines
Description
Measured in the blood, a panel of 27 cytokines of relevance for inflammatory status (Bio-Plex Pro Human Cytokine 27-plex Assay)
Time Frame
Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
Title
Adipokines (Adiponectin, Leptin, Ghrelin)
Description
Measured in the maternal blood
Time Frame
Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
Title
Homocysteine
Description
Measured in the maternal blood
Time Frame
Baseline, intervention week 8, gestational week 12 and 28
Title
Insulin sensitivity
Description
Insulin sensitivity estimated by homeostatic model assessment for insulin resistance (fasting serum insulin concentration (μU/mL) x fasting plasma glucose levels (mmol/L)/22.5)
Time Frame
Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
Title
Total body mass
Description
Estimated using InBody720 bioimpedance scale.
Time Frame
Baseline, intervention week 8, gestational week 12 and 28
Title
Fat mass
Description
Estimated using InBody720 bioimpedance scale.
Time Frame
Baseline, intervention week 8, gestational week 12 and 28
Title
Muscle mass
Description
Estimated using InBody720 bioimpedance scale.
Time Frame
Baseline, intervention week 8, gestational week 12 and 28
Title
Visceral fat area
Description
Estimated using InBody720 bioimpedance scale.
Time Frame
Baseline, intervention week 8, gestational week 12 and 28
Title
Continuous glucose monitoring
Description
Continuous glucose monitoring using Freestyle Libre (Abbott Diabetes Care), worn for 14 days.
Time Frame
Baseline and 8 weeks intervention
Title
Cardiorespiratory fitness
Description
Peak oxygen uptake at a maximum effort exercise test, measured in L/min using Metalyzer.
Time Frame
Baseline and intervention week 8
Title
Blood pressure
Description
Systolic - and diastolic blood pressure (in mmHg) will be measured in the seated position after 15 minutes of rest with an automatic blood pressure device (Welch Allyn, Germany) three times with one minute intervals, in left arm (average of three measurement).
Time Frame
Baseline, intervention week 8, gestational week 12 and 28
Title
Measured physical activity
Description
Measured by SenseWear activity monitor, worn for 7 days.
Time Frame
Baseline
Title
Measured physical activity
Description
Measured by Amazfit GTS smartwatch
Time Frame
From baseline and throughout the study period.
Title
Diet intake
Description
Online food diary (Lifesum app), 4-day registration (one weekend day and three weekdays=
Time Frame
Every 8 week throughout the trial.
Title
Self-reported physical activity
Description
International Physical Activity Questionnaire
Time Frame
Baseline, intervention week 8, gestational week 12 and 28, and every 8 week until delivery or until the participant is excluded from the trial due to not conceiving within 6 months from baseline
Title
Sleep
Description
Self-reported: Pittsburgh Sleep Quality Index
Time Frame
Baseline, intervention week 8, gestational week 12 and 28, and every 8 week until delivery or until the participant is excluded from the trial due to not conceiving within 6 months from baseline
Title
Chronotype
Description
Self-reported: Hornestberg Morningness Eveningness Questionnaire
Time Frame
Baseline, intervention week 8, gestational week 12 and 28, and every 8 week until delivery or until the participant is excluded from the trial due to not conceiving within 6 months from baseline
Title
Psychological general well being
Description
Psychological general well being index (PGWBI)
Time Frame
Baseline, intervention week 8, gestational week 12 and 28, and every 8 week until delivery or until the participant is excluded from the trial due to not conceiving within 6 months from baseline
Title
Time to pregnancy
Description
Self-reported
Time Frame
From baseline to pregnancy (up to 36 weeks from enrollment)
Title
Psychological well-being
Description
Self-reported: Psychological General Well Being Index
Time Frame
Baseline, intervention week 8, gestational week 12 and 28 and every 8 week throughout the trial.
Title
Birth weight (infant)
Description
From hospital record
Time Frame
Delivery
Title
Birth length (infant)
Description
From hospital record
Time Frame
Delivery
Title
Head circumference of infant
Description
From hospital record
Time Frame
Delivery
Title
Apgar score
Description
From hospital record
Time Frame
Delivery, after 1, 5 and 10 minutes
Title
ICU admission
Description
From hospital record
Time Frame
Delivery
Title
Congenital malformation
Description
From hospital record
Time Frame
Delivery
Title
Gestational age at birth
Description
From hospital record
Time Frame
Delivery
Title
Length of stay at hospital
Description
From hospital record
Time Frame
Delivery
Title
Blood pressure (Infant)
Description
Blood pressure (systolic - and diastolic)
Time Frame
Within 72 hours of birth and after 6 weeks post delivery
Title
Cardiac function (Infant)
Description
Ultrasound echocardiography
Blood flow and myocardial function will be measured using mechanical wave imaging (MWI).
Time Frame
Within 72 hours of birth and after 6 weeks post delivery
Title
Infant total body mass
Description
Estimated using impedance measurements (BioScan tough i8-nano)
Time Frame
Within 72 hours of birth and after 6 weeks post delivery
Title
Infant muscle mass
Description
Estimated using impedance measurements (BioScan tough i8-nano)
Time Frame
Within 72 hours of birth and after 6 weeks post delivery
Title
Infant fat mass
Description
Estimated using impedance measurements (BioScan tough i8-nano)
Time Frame
Within 72 hours of birth and after 6 weeks post delivery
Title
Infant hydration status
Description
Estimated using impedance measurements (BioScan tough i8-nano)
Time Frame
Within 72 hours of birth and after 6 weeks post delivery
Title
Infant bone mass
Description
Estimated using impedance measurements (BioScan tough i8-nano)
Time Frame
Within 72 hours of birth and after 6 weeks post delivery
Other Pre-specified Outcome Measures:
Title
Infant gut microbiome
Description
Sequencing of faecal samples
Time Frame
Within one week of birth, after 6 weeks and after 6 months
Title
Maternal gut microbiome
Description
Sequencing of faecal samples
Time Frame
After 6 weeks after delivery and after 6 months
Title
Breastmilk composition
Description
Breastmilk sampling, for storage (outcomes will be exploratory, not yet specified)
Time Frame
After 6 weeks after delivery and after 6 months
Title
Infant total body mass
Description
Estimated using impedance measurements (BioScan tough i8-nano)
Time Frame
At age of 6 months
Title
Infant fat mass
Description
Estimated using impedance measurements (BioScan tough i8-nano)
Time Frame
At age of 6 months
Title
Infant muscle mass
Description
Estimated using impedance measurements (BioScan tough i8-nano)
Time Frame
At age of 6 months
Title
Infant hydration status
Description
Estimated using impedance measurements (BioScan tough i8-nano)
Time Frame
At age of 6 months
Title
Infant bone mass
Description
Estimated using impedance measurements (BioScan tough i8-nano)
Time Frame
At age of 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
contemplating pregnancy within the next six months
At least one of the following criteria: BMI ≥ 25 < 40 kg/m2, gestational diabetes in a previous pregnancy, previous infant > 4.5 kg, fasting plasma glucose > 5.3 mmol/L, or Non-European ethnicity
Exclusion Criteria:
On-going pregnancy
Trying to conceive ≥ 6 cycles at study entry
Known diabetes (type 1 or 2)
Shift work that includes night shifts > 2 days per week
Previous hyperemesis
Known cardiovascular diseases
High intensity exercise ≥ 2 hours/week the last 3 months
Habitual eating window ≤ 12 hours
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Øystein Risa
Organizational Affiliation
Norwegian University of Science and Technology, Fac MH ISB
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kjell Å Salvesen, md prof
Organizational Affiliation
St Olavs Hospital, Dept Obstetrics & Gynecology
Official's Role
Study Director
Facility Information:
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We will share individual participant data that underlie the results in publications, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Immediately following publication, with no end date.
IPD Sharing Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, to achieve aims in the approved proposals, or for individual participant data meta-analyses. Proposals should be directed to trine.moholdt@ntnu.no. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Preconception Lifestyle Interventions to Improve Future Metabolic Health (Before the Beginning)
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