Interval Walking Intervention for Pregnant Women Diagnosed With Gestational Diabetes Mellitus

July 24, 2018 updated by: Kathrine Kjaer, The Danish Center for Strategic Research on Type 2 Diabetes

Interval Walking Intervention for Pregnant Women Diagnosed With Gestational Diabetes Mellitus - a Pilot Study

It is well-known that regular physical activity (PA) can improve glycemic control and physical fitness in type 2 diabetes patients. However, studies examining the effects of PA in patients with gestational diabetes mellitus (GDM) are limited. Interval walking training (IWT) is a careful type of PA consisting of repeatedly cycles of 3 min. fast and slow walking. The investigators aimed to examine, if IWT is feasible as PA intervention for GDM patients, and to examine the effects of IWT on glycemic control, PA levels and physical fitness.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Gestational diabetes mellitus (GDM), defined as glucose intolerance and thus hyperglycemia with onset or first recognition during pregnancy, is steadily increasing in prevalence. In Denmark, the prevalence of GDM is around 2-3% of all pregnancies. GDM is associated with several adverse perinatal and maternal outcomes why early recognition and diagnosis is important. Early diagnosis and relevant treatment can prevent adverse outcomes of the baby and mother, such as macrosomia, shoulder dystocia, preeclampsia and hypoglycemia.

The glucose levels will often normalize shortly after birth; however, up to 50% of all women in Denmark diagnosed with GDM develop T2D during the first 10 years after the pregnancy, have a threefold risk of developing metabolic syndrome2 10, while the recurrence risk of developing GDM in subsequent pregnancies varies between 30-84%. Furthermore, long term increased risks for children born with macrosomia or by a mother with GDM include cardiovascular disease, obesity and T2D.

Glycemic control is a key factor in combatting the severe effects related to poorly controlled GDM. Management of GDM in Denmark consists of regular BG self-monitoring, dietary modifications, and in some cases insulin treatment. Additionally, obstetric control visits and PA advices are also a part of the standard GDM care program.

Compared to non-pregnant women, pregnant women must be more careful in relation to especially the type of PA, why supervised exercise is often recommended in order to ensure safe and correct guidance. This is a heavy economic burden, why a structured, non-supervised type of PA with low a risk of injury, possibly high compliance and continuous monitoring would be preferable. Interval walking training (IWT) is a lenient type of structured, non-supervised PA. This type of PA is associated with an improved glucose regulation in patients with T2D after 4 months of IWT 5 times weekly (60 min./session) (Karstoft et al., 2013). Due to similar metabolic dysregulations in patients with T2D and GDM, the investigators are apt to believe that IWT, if feasible, can improve glycemic control in GDM patients. Furthermore, it is obvious to believe that IWT can be implemented as regular PA in GDM patients, as one study has shown that pregnant women mostly prefer walking as a type of PA during pregnancy.

This open-label randomized controlled trial aims to enroll 20 patients randomized (1:1) to a control- (Con) or IWT-group. Both groups will follow the standard GDM care program at Odense University Hospital. Additionally, the IWT-group is prescribed three weekly IWT sessions of 40-50 minutes each for 6 weeks. Each IWT session is guided and controlled by the smartphone application 'InterWalk', which individualize the training intensity to current fitness level of the patient through an on-board fitness test.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Danish Centre of strategic research of type 2 diabetes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Diagnosed with GDM by a 2 hour oral glucose tolerance test with a BG level of >9.00mmol/l at 2 hours
  • Danish speaking
  • >18 years of age
  • Live <20 kilometers from Odense city center

Exclusion Criteria:

  • Pelvic pains
  • Untreated depression
  • Walking disabilities
  • Pregnancy-related complications
  • >32 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: IWT-group
The IWT-group follows the standardized GDM care program for GDM patients at OUH and is prescribed to a 6-week non-supervised IWT-program consisting of 3 IWT sessions per week of 40-50 minutes each.
Behavioral: IWT-group
NO_INTERVENTION: Con-group
The con-group follows the standardized GDM care program for GDM patients at OUH

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Compliance to the prescribed IWT-intervention
Time Frame: After the 6-week intervention period
Compliance defined as adherence to the prescribed IWT-intervention
After the 6-week intervention period
Compliance to the prescribed IWT-intervention
Time Frame: After the 6-week intervention period
Compliance defined as the quality of the the IWT sessions
After the 6-week intervention period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: Before and after the 6-week intervention period
Blood glucose variations measured by 48-hour continuous glucose monitoring
Before and after the 6-week intervention period
Physical activity level
Time Frame: 7 days before and after the 6-week intervention period, and the first and last 5 days during the 6-week intervention period
Physical activity level measured by accelerometers
7 days before and after the 6-week intervention period, and the first and last 5 days during the 6-week intervention period
Physical fitness
Time Frame: Before and after the 6-week intervention period
Physical fitness measured by the on-board fitness test in the InterWalk application and a 6-minute walking test
Before and after the 6-week intervention period

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: Before and after the 6-week intervention period
30 minutes systolic and diastolic Blood Pressure (BP) together with pulse wave velocity (PWV) was measured by using the Mobil-O Graph® PWA device. BP and PWV was measured every 3 minutes for 30 minutes in a sitting position with the assessor only being in the room during the first measurement to ensure adequate quality.
Before and after the 6-week intervention period
Physical and mental health
Time Frame: Before and after the 6-week intervention period
Perceived physical and mental health was measured using the SF-12 questionnaire.
Before and after the 6-week intervention period
BMI
Time Frame: Before and after the 6-week intervention period
Body height and body weight were objectively measured. Height was measured in an upright standing position without shoes by using a stadiometer. Weight was also measured in a standing position without shoes by using a digital scale. Height and weight was measured to the nearest 0.5 centimeter and 0.1 kilo respectively. BMI was calculated based on measured height and weight
Before and after the 6-week intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Danish Center for Strategic Research on Type 2 Diabetes

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 3, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT20160156
  • S-20160156 (OTHER: The Regional Committees on Health Research Ethics for Southern Denmark)
  • 16/40511 (OTHER: The Danish Data Protection Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Dietary Supplements

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