Exercise Timing and Gestational Diabetes

NCT ID: NCT05256615

Last Updated: 2024-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2024-06-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Related Diabetes Diabete Mellitus Type 2 Diabetes Pre-diabetes Exercise

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study comprises of two groups; a diabetes and a non-diabetes group.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diabetes

Participants recruited to this arm have been clinically diagnosed with either gestational, pre- or type 2 diabetes.

Group Type EXPERIMENTAL

30-minute walking intervention

Intervention Type BEHAVIORAL

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-minute

Intervention Type BEHAVIORAL

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.

Non-diabetes

Participants recruited to this arm of the study do not have gestational, pre- or type 2 diabetes.

Group Type EXPERIMENTAL

30-minute walking intervention

Intervention Type BEHAVIORAL

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-minute

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

30-minute walking intervention

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

10-minute

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LONG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alberta

Edmonton, Alberta, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00097525

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.