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Pregnancy RelatedNCT05256615

Exercise Timing and Gestational Diabetes

A study testing 30-minute walking intervention and 10-minute in people with Pregnancy Related and Diabetes, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy Related, Diabetes, Diabete Mellitus
What is being tested?
30-minute walking intervention and 10-minute
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteCanada
Study dates
1 Jan 2020to 7 Jun 2024
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 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • at least 18 years of age
  • singleton pregnancies
  • healthy pregnant individuals or diagnosed with gestational, pre- or Type 2 diabetes

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Alberta

    Edmonton, Alberta, T6G 2E1

Other trials in Canada

About this study

Official title: Optimizing Blood Glucose Control in Pregnant Women Diagnosed With Gestational and Type 2 Diabetes Mellitus.

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.

Read the 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.

Being tested
30-minute walking intervention, 10-minute
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Intolerance, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 30-minute walking interventionBehavioural

    Also called LONG

    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.

  • 10-minuteBehavioural

    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.

Study groups in NCT05256615
Study groupRoleWhat they receive
DiabetesExperimentalParticipants recruited to this arm have been clinically diagnosed with either gestational, pre- or type 2 diabetes.
Receives: Behavioral: 30-minute walking intervention; Behavioral: 10-minute
Non-diabetesExperimentalParticipants recruited to this arm of the study do not have gestational, pre- or type 2 diabetes.
Receives: Behavioral: 30-minute walking intervention; Behavioral: 10-minute

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 1 to Day 14

  2. 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).

    Measured: Day 1 to Day 14

  3. 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)

    Measured: Day 1 to Day 14

Secondary outcomes (8)

  1. 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.

    Measured: Day 3-7 and day 9-14

  2. 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).

    Measured: Pre-intervention

  3. 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).

    Measured: Pre-intervention

  4. 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.

    Measured: Pre-intervention

  5. 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.

    Measured: Days 1 - 14

  6. 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.

    Measured: Through study completion - an average of 1 year postpartum

  7. 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.

    Measured: Through study completion - an average of 1 year postpartum

  8. Infant Apgar Scores

    Apgar scores will be collected from medical notes. An apgar score

    Measured: Through study completion - an average of 1 year postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2022
  2. Study start1 Jan 2020
  3. Primary completion7 Jun 2024
  4. Study completion7 Jun 2024

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study comprises of two groups; a diabetes and a non-diabetes group.
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05256615
Sponsor's protocol ID
Pro00097525
Status last verified
Jul 2024
First submitted
23 Dec 2021
Last updated
24 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 30-minute walking intervention and 10-minute in people with Pregnancy Related and Diabetes, run by University of Alberta at 1 site in Canada.

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 3 inclusion and 4 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 24 Jul 2024. 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 Canada. 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?

Postprandial blood glucose (mmol/l) (time frame: Day 1 to Day 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05256615.

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 24 Jul 2024.

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