Exercise Timing and Gestational Diabetes
Primary Purpose
Pregnancy Related, Diabetes, Diabete Mellitus
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
30-minute walking intervention
10-minute
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy Related
Eligibility Criteria
Inclusion Criteria:
- at least 18 years of age
- singleton pregnancies
- healthy pregnant individuals or diagnosed with gestational, pre- or Type 2 diabetes
Exclusion Criteria:
- less than 18 years of age
- presents with contraindications to prenatal exercise (e.g., preeclampsia)
- multiple pregnancies (i.e. twins, triplets etc.)
- currently taking Metformin
Sites / Locations
- University of AlbertaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Diabetes
Non-diabetes
Arm Description
Participants recruited to this arm have been clinically diagnosed with either gestational, pre- or type 2 diabetes.
Participants recruited to this arm of the study do not have gestational, pre- or type 2 diabetes.
Outcomes
Primary Outcome Measures
Postprandial blood glucose (mmol/l)
Mean, peak and nadir 24 hour daily glucose, glycemic variability, fasting glucose, time spent in hyperglycemia (>10mmol/l), and time spent in hypoglycemia (<3.5mmol/l). These values will be compared between pregnant individuals diagnosed with gestational, pre- or Type 2 diabetes, and healthy pregnant individuals. High postprandial glucose level indicates poor blood glucose control.
Daily physical activity (minutes per day)
All participants will be asked to wear an accelerometer (Actigraph wGT3X-BT Monitor, Actigraph LLC) for fourteen consecutive days to record 24-hour physical activity (min/d). This information will be collected to determine overall physical activity and movement behaviours (including light, moderate and vigorous activity intensity).
Sleep (minutes per night)
All participants will be asked to wear an accelerometer (Actigraph wGT3X-BT Monitor, Actigraph LLC) for fourteen consecutive nights to record 24-hour physical activity (min/d). This information will be collected to determine total sleep time (min/day)
Secondary Outcome Measures
Heart rate (bpm)
Participants will be lent a heart rate monitor chest strap and watch (Polar) to wear during their walking sessions to confirm they are in the prescribed intensity range. The chest strap is worn around the chest with the sensor placed just inferior to the sternum. It wirelessly connects to the watch which displays their heart rate in beats per minute (BPM). Participants are asked to maintain a heart rate 0f 101 - 146 bpm to represent moderate intensity physical activity.
Health history questionnaires
Health history (personal and familial) may affect the results of variables assessed within this study. Participants will be asked about their age (years), height (cm) and weight) (kg). They will also be asked about their pregnancy health and any complications that should be noted. The over all purpose of this questionnaire is to allow us describe the type of participant recruited to this study. This questionnaire can be submitted online via Redcap, or by hard copy (if requested).
Physical activity questionnaires
We will use a questionnaire prior to the intervention to estimate participants physical activity level using the Pregnancy Physical Activity Questionnaire. Total activity time will be computed (min/day) from this. This questionnaire can be submitted online via Redcap, or by hard copy (if requested).
Sleep quality questionnaire
We will use a questionnaire prior to the intervention to estimate participants sleep quality using the Pittsburgh Sleep Quality Index. This questionnaire can be submitted online via Redcap, or by hard copy (if requested). Each component is scored on a scale of 0-3 with higher values representing greater sleep dysfunction.
Food Diary
Diet may affect the results of variables assessed within this study. We will ask participants to keep a hand written diary log for the duration of the study about the type and amount (grams) of food intake they are consuming.
Maternal outcomes
Data on maternal complications if any, will be recorded from medical notes. This may include although not limited to diagnosis of pre-eclampsia, hypertension in pregnancy, caesarean section, birth complications, instrumental delivery, blood loss, and length of labour. These outcomes will be collected as categorical variables with 'yes ' or 'no' as an answer.
Infant outcomes
Data on infant outcomes will be recorded from medical notes. This may include although not limited to weeks of gestation at birth, birth weight, hypoglycemia at birth, admission to NICU, breastfeeding status, infant mortality, and 2-month development. These outcomes will be collected as categorical variables with 'yes ' or 'no' as an answer.
Infant Apgar Scores
Apgar scores will be collected from medical notes. An apgar score
Full Information
NCT ID
NCT05256615
First Posted
December 23, 2021
Last Updated
October 19, 2023
Sponsor
University of Alberta
1. Study Identification
Unique Protocol Identification Number
NCT05256615
Brief Title
Exercise Timing and Gestational Diabetes
Official Title
Optimizing Blood Glucose Control in Pregnant Women Diagnosed With Gestational and Type 2 Diabetes Mellitus.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
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 understand if the timing of exercise around food intake can help improve blood sugar management in pregnant individuals with diabetes.
Detailed Description
Between 3 - 20% of women develop gestational diabetes mellitus (GDM) during pregnancy, a condition in which blood sugar control is poor and can have serious health effects for both mom and baby. Women with GDM are at elevated risk of developing dangerously high blood pressure during pregnancy and type 2 diabetes later in life. GDM also puts the baby at an increased risk of excessive birth weight, low blood sugar at birth, and future risk of type 2 diabetes.
The 2019 Canadian Guideline for Physical Activity throughout Pregnancy recommends that women be physically active for at least 150 minutes spread over at least 3 days each week. Managing high blood sugars with exercise improves outcomes for mom and baby; however, optimal timing of exercise has not been investigated.
The goal of this study is to determine if exercising after meals in shorter bouts is more effective at controlling post-meal blood sugars than exercising in larger amounts between meals.
This is a fully remote study; participants will receive all necessary equipment in the mail and all interactions with the researcher will be done via phone, video call and email.
The study will recruit 30 pregnant women diagnosed (or not) with diabetes (gestational, pre-, or type 2 diabetes mellitus) after 20 weeks' gestation to participate in this 2-week study. Following a 2 day baseline period, they will be randomly assigned to: 1) walk for 10 minutes after each meal (SHORT), or 2) walk for 30 minutes once per day at any time except in the hour after eating (LONG) for 5 days. Following a 2- day washout period, women will then complete the alternative exercise protocol for an additional 5 days. Women will wear a Continuous Glucose Monitor to track blood sugars, and an accelerometer to track activity patterns (e.g., compliance to the intervention) for seven consecutive days. The Investigators hypothesize that women who walk for 10 minutes after each meal will have a blunted rise in blood sugar following food intake, compared to the women in the 30- minute walking group. Findings from this novel study may help better treat GDM, improving lifelong health for moms and babies around the world.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Diabetes, Diabete Mellitus, Type 2 Diabetes, Pre-diabetes, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study comprises of two groups; a diabetes and a non-diabetes group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diabetes
Arm Type
Experimental
Arm Description
Participants recruited to this arm have been clinically diagnosed with either gestational, pre- or type 2 diabetes.
Arm Title
Non-diabetes
Arm Type
Experimental
Arm Description
Participants recruited to this arm of the study do not have gestational, pre- or type 2 diabetes.
Intervention Type
Behavioral
Intervention Name(s)
30-minute walking intervention
Other Intervention Name(s)
LONG
Intervention Description
Participants are asked to go for a 30 minute walk once per day at any time except the 1 hour after a meal. During these walks they are asked to record heart rate using a heart rate monitor and a phone application.
Intervention Type
Behavioral
Intervention Name(s)
10-minute
Intervention Description
Participants are asked to go for a 10-minute walk after each meal occurring 3 times daily. During these walks they are asked to record heart rate using a heart rate monitor and a phone application.
Primary Outcome Measure Information:
Title
Postprandial blood glucose (mmol/l)
Description
Mean, peak and nadir 24 hour daily glucose, glycemic variability, fasting glucose, time spent in hyperglycemia (>10mmol/l), and time spent in hypoglycemia (<3.5mmol/l). These values will be compared between pregnant individuals diagnosed with gestational, pre- or Type 2 diabetes, and healthy pregnant individuals. High postprandial glucose level indicates poor blood glucose control.
Time Frame
Day 1 to Day 14
Title
Daily physical activity (minutes per day)
Description
All participants will be asked to wear an accelerometer (Actigraph wGT3X-BT Monitor, Actigraph LLC) for fourteen consecutive days to record 24-hour physical activity (min/d). This information will be collected to determine overall physical activity and movement behaviours (including light, moderate and vigorous activity intensity).
Time Frame
Day 1 to Day 14
Title
Sleep (minutes per night)
Description
All participants will be asked to wear an accelerometer (Actigraph wGT3X-BT Monitor, Actigraph LLC) for fourteen consecutive nights to record 24-hour physical activity (min/d). This information will be collected to determine total sleep time (min/day)
Time Frame
Day 1 to Day 14
Secondary Outcome Measure Information:
Title
Heart rate (bpm)
Description
Participants will be lent a heart rate monitor chest strap and watch (Polar) to wear during their walking sessions to confirm they are in the prescribed intensity range. The chest strap is worn around the chest with the sensor placed just inferior to the sternum. It wirelessly connects to the watch which displays their heart rate in beats per minute (BPM). Participants are asked to maintain a heart rate 0f 101 - 146 bpm to represent moderate intensity physical activity.
Time Frame
Day 3-7 and day 9-14
Title
Health history questionnaires
Description
Health history (personal and familial) may affect the results of variables assessed within this study. Participants will be asked about their age (years), height (cm) and weight) (kg). They will also be asked about their pregnancy health and any complications that should be noted. The over all purpose of this questionnaire is to allow us describe the type of participant recruited to this study. This questionnaire can be submitted online via Redcap, or by hard copy (if requested).
Time Frame
Pre-intervention
Title
Physical activity questionnaires
Description
We will use a questionnaire prior to the intervention to estimate participants physical activity level using the Pregnancy Physical Activity Questionnaire. Total activity time will be computed (min/day) from this. This questionnaire can be submitted online via Redcap, or by hard copy (if requested).
Time Frame
Pre-intervention
Title
Sleep quality questionnaire
Description
We will use a questionnaire prior to the intervention to estimate participants sleep quality using the Pittsburgh Sleep Quality Index. This questionnaire can be submitted online via Redcap, or by hard copy (if requested). Each component is scored on a scale of 0-3 with higher values representing greater sleep dysfunction.
Time Frame
Pre-intervention
Title
Food Diary
Description
Diet may affect the results of variables assessed within this study. We will ask participants to keep a hand written diary log for the duration of the study about the type and amount (grams) of food intake they are consuming.
Time Frame
Days 1 - 14
Title
Maternal outcomes
Description
Data on maternal complications if any, will be recorded from medical notes. This may include although not limited to diagnosis of pre-eclampsia, hypertension in pregnancy, caesarean section, birth complications, instrumental delivery, blood loss, and length of labour. These outcomes will be collected as categorical variables with 'yes ' or 'no' as an answer.
Time Frame
Through study completion - an average of 1 year postpartum
Title
Infant outcomes
Description
Data on infant outcomes will be recorded from medical notes. This may include although not limited to weeks of gestation at birth, birth weight, hypoglycemia at birth, admission to NICU, breastfeeding status, infant mortality, and 2-month development. These outcomes will be collected as categorical variables with 'yes ' or 'no' as an answer.
Time Frame
Through study completion - an average of 1 year postpartum
Title
Infant Apgar Scores
Description
Apgar scores will be collected from medical notes. An apgar score
Time Frame
Through study completion - an average of 1 year postpartum
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Due to the topic of this study, this study targets female gender.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
at least 18 years of age
singleton pregnancies
healthy pregnant individuals or diagnosed with gestational, pre- or Type 2 diabetes
Exclusion Criteria:
less than 18 years of age
presents with contraindications to prenatal exercise (e.g., preeclampsia)
multiple pregnancies (i.e. twins, triplets etc.)
currently taking Metformin
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margie Davenport, PhD
Phone
7804920642
Email
mdavenpo@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Aine Brislane, PhD
Phone
5875948539
Email
brislane@ualberta.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Exercise Timing and Gestational Diabetes
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