Preconception Lifestyle Interventions to Improve Future Metabolic Health (Before the Beginning)

Gestational Diabetes Clinical Trial

Official title:

Before the Beginning: Preconception Lifestyle Interventions to Improve Future Metabolic Health

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04585581
• Other study ID #: 143756
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 6, 2020
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 167
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Behavioral:
• time-restricted eating
Participants will be asked to limit the time-window for their daily energy intake to a maximum of 10 hours.
• high intensity exercise
Participants will be encouraged to exercise with high intensity 2-3 times per week

Other:
• Standard Care
Standard clinical care

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Infant gut microbiome	Sequencing of faecal samples	Within one week of birth, after 6 weeks and after 6 months
Other	Maternal gut microbiome	Sequencing of faecal samples	After 6 weeks after delivery and after 6 months
Other	Breastmilk composition	Breastmilk sampling, for storage (outcomes will be exploratory, not yet specified)	After 6 weeks after delivery and after 6 months
Other	Infant total body mass	Estimated using impedance measurements (BioScan tough i8-nano)	At age of 6 months
Other	Infant fat mass	Estimated using impedance measurements (BioScan tough i8-nano)	At age of 6 months
Other	Infant muscle mass	Estimated using impedance measurements (BioScan tough i8-nano)	At age of 6 months
Other	Infant hydration status	Estimated using impedance measurements (BioScan tough i8-nano)	At age of 6 months
Other	Infant bone mass	Estimated using impedance measurements (BioScan tough i8-nano)	At age of 6 months
Primary	Plasma glucose concentration	Plasma glucose concentration after 2 h oral glucose tolerance testing (75 g glucose)	Gestational week 28
Secondary	Plasma glucose concentration	Plasma glucose concentration after 2 h oral glucose tolerance testing (75 g glucose)	Gestational week 12
Secondary	HbA1c	Measured in the maternal blood	Baseline, intervention week 8, gestational week 12 and 28
Secondary	Total cholesterol	Measured in the maternal blood	Baseline, intervention week 8, gestational week 12 and 28
Secondary	Triglycerides	Measured in the maternal blood	Baseline, intervention week 8, gestational week 12 and 28
Secondary	High density lipoprotein cholesterol	Measured in the maternal blood	Baseline, intervention week 8, gestational week 12 and 28
Secondary	Low density lipoprotein cholesterol	Measured in the maternal blood	Baseline, intervention week 8, gestational week 12 and 28
Secondary	Low density cholesterol	Measured in the maternal blood	Baseline, intervention week 8, gestational week 12 and 28
Secondary	Glucose	Measured in the blood	Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
Secondary	Insulin	Measured in the blood	Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
Secondary	Cytokines	Measured in the blood, a panel of 27 cytokines of relevance for inflammatory status (Bio-Plex Pro Human Cytokine 27-plex Assay)	Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
Secondary	Adipokines (Adiponectin, Leptin, Ghrelin)	Measured in the maternal blood	Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
Secondary	Homocysteine	Measured in the maternal blood	Baseline, intervention week 8, gestational week 12 and 28
Secondary	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)	Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
Secondary	Total body mass	Estimated using InBody720 bioimpedance scale.	Baseline, intervention week 8, gestational week 12 and 28
Secondary	Fat mass	Estimated using InBody720 bioimpedance scale.	Baseline, intervention week 8, gestational week 12 and 28
Secondary	Muscle mass	Estimated using InBody720 bioimpedance scale.	Baseline, intervention week 8, gestational week 12 and 28
Secondary	Visceral fat area	Estimated using InBody720 bioimpedance scale.	Baseline, intervention week 8, gestational week 12 and 28
Secondary	Continuous glucose monitoring	Continuous glucose monitoring using Freestyle Libre (Abbott Diabetes Care), worn for 14 days.	Baseline and 8 weeks intervention
Secondary	Cardiorespiratory fitness	Peak oxygen uptake at a maximum effort exercise test, measured in L/min using Metalyzer.	Baseline and intervention week 8
Secondary	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).	Baseline, intervention week 8, gestational week 12 and 28
Secondary	Measured physical activity	Measured by SenseWear activity monitor, worn for 7 days.	Baseline
Secondary	Measured physical activity	Measured by Amazfit GTS smartwatch	From baseline and throughout the study period.
Secondary	Diet intake	Online food diary (Lifesum app), 4-day registration (one weekend day and three weekdays=	Every 8 week throughout the trial.
Secondary	Self-reported physical activity	International Physical Activity Questionnaire	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
Secondary	Sleep	Self-reported: Pittsburgh Sleep Quality Index	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
Secondary	Chronotype	Self-reported: Hornestberg Morningness Eveningness Questionnaire	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
Secondary	Psychological general well being	Psychological general well being index (PGWBI)	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
Secondary	Time to pregnancy	Self-reported	From baseline to pregnancy (up to 36 weeks from enrollment)
Secondary	Psychological well-being	Self-reported: Psychological General Well Being Index	Baseline, intervention week 8, gestational week 12 and 28 and every 8 week throughout the trial.
Secondary	Birth weight (infant)	From hospital record	Delivery
Secondary	Birth length (infant)	From hospital record	Delivery
Secondary	Head circumference of infant	From hospital record	Delivery
Secondary	Apgar score	From hospital record	Delivery, after 1, 5 and 10 minutes
Secondary	ICU admission	From hospital record	Delivery
Secondary	Congenital malformation	From hospital record	Delivery
Secondary	Gestational age at birth	From hospital record	Delivery
Secondary	Length of stay at hospital	From hospital record	Delivery
Secondary	Blood pressure (Infant)	Blood pressure (systolic - and diastolic)	Within 72 hours of birth and after 6 weeks post delivery
Secondary	Cardiac function (Infant)	Ultrasound echocardiography; Blood flow and myocardial function will be measured using mechanical wave imaging (MWI).	Within 72 hours of birth and after 6 weeks post delivery
Secondary	Infant total body mass	Estimated using impedance measurements (BioScan tough i8-nano)	Within 72 hours of birth and after 6 weeks post delivery
Secondary	Infant muscle mass	Estimated using impedance measurements (BioScan tough i8-nano)	Within 72 hours of birth and after 6 weeks post delivery
Secondary	Infant fat mass	Estimated using impedance measurements (BioScan tough i8-nano)	Within 72 hours of birth and after 6 weeks post delivery
Secondary	Infant hydration status	Estimated using impedance measurements (BioScan tough i8-nano)	Within 72 hours of birth and after 6 weeks post delivery
Secondary	Infant bone mass	Estimated using impedance measurements (BioScan tough i8-nano)	Within 72 hours of birth and after 6 weeks post delivery