Gestational Diabetes Mellitus in PregnancyNCT03229161
Interval Walking Intervention for Pregnant Women Diagnosed With Gestational Diabetes Mellitus
A study testing IWT-group in people with Gestational Diabetes Mellitus in Pregnancy, run by The Danish Center for Strategic Research on Type 2 Diabetes at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- IWT-group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Jan 2017to 1 May 2018
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pelvic pains
- Untreated depression
- Walking disabilities
- Pregnancy-related complications
- >32 weeks
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Centre of strategic research of type 2 diabetes
Odense, 5000
About this study
Official title: 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.
Read the 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.
- Being tested
- IWT-group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IWT-groupBehavioural
| Study group | Role | What they receive |
|---|---|---|
| IWT-group | Experimental | 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. Receives: Behavioral: IWT-group |
| Con-group | No intervention | The con-group follows the standardized GDM care program for GDM patients at OUH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to the prescribed IWT-intervention
Compliance defined as adherence to the prescribed IWT-intervention
Measured: After the 6-week intervention period
Compliance to the prescribed IWT-intervention
Compliance defined as the quality of the the IWT sessions
Measured: After the 6-week intervention period
Secondary outcomes (3)
Glycemic control
Blood glucose variations measured by 48-hour continuous glucose monitoring
Measured: Before and after the 6-week intervention period
Physical activity level
Physical activity level measured by accelerometers
Measured: 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
Physical fitness measured by the on-board fitness test in the InterWalk application and a 6-minute walking test
Measured: Before and after the 6-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start3 Jan 2017
- Primary completion31 May 2017
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This open-label randomized controlled trial aims to enroll 20 patients randomized (1:1) to a control- (Con) or IWT-group. Patients in both the IWT- and Con-group follows the standardized GDM care program for GDM patients at OUH through the 6-week intervention period, which consists of instruction of self-monitoring of BG levels, dietary guidance, and in some cases, insulin treatment. Additionally, the program also consists of close obstetric control visits and exercise guidance. All patients are instructed not to start any new type of PA after inclusion and continue their lives without any changes. Patients randomized to the IWT-group goes through a 6-week non-supervised IWT-program, where they are prescribed to conduct 3 IWT sessions per week of 40-50 minutes each. Before and after the 6-week intervention, maternal blood glucose (BG) levels is measured by continuous glucose monitoring, PA level measured using accelerometers and physical fitness measured using two walking tests.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Danish Center for Strategic Research on Type 2 Diabetes
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Principal investigator, Kathrine Kjaer, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229161
- Sponsor's protocol ID
- CT20160156
- Other IDs
- S-20160156, 16/40511
- Status last verified
- Jul 2018
- First submitted
- 28 Jun 2017
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interval Walking Intervention for Pregnant Women Diagnosed With Gestational Diabetes Mellitus - a Pilot Study
- ClinicalTrials.gov ID
- NCT03229161
- Acronym / sponsor ID
- CT20160156
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The Danish Center for Strategic Research on Type 2 DiabetesUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 25 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This open-label randomized controlled trial aims to enroll 20 patients randomized (1:1) to a control- (Con) or IWT-group. Patients in both the IWT- and Con-group follows the standardized GDM care program for GDM patients at OUH through the 6-week intervention period, which consists of instruction of self-monitoring of BG levels, dietary guidance, and in some cases, insulin treatment. Additionally, the program also consists of close obstetric control visits and exercise guidance. All patients are instructed not to start any new type of PA after inclusion and continue their lives without any changes. Patients randomized to the IWT-group goes through a 6-week non-supervised IWT-program, where they are prescribed to conduct 3 IWT sessions per week of 40-50 minutes each. Before and after the 6-week intervention, maternal blood glucose (BG) levels is measured by continuous glucose monitoring, PA level measured using accelerometers and physical fitness measured using two walking tests.
| Arm | Type | Receives |
|---|---|---|
| IWT-group | Experimental | Behavioral: IWT-groupThe 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. |
| Con-group | No intervention | –The con-group follows the standardized GDM care program for GDM patients at OUH |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Pelvic pains
- Untreated depression
- Walking disabilities
- Pregnancy-related complications
- >32 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IWT-group | Behavioural | IWT-group |
Primary outcome
Compliance to the prescribed IWT-intervention
Time frame: After the 6-week intervention period
Compliance defined as adherence to the prescribed IWT-intervention
Compliance to the prescribed IWT-intervention
Time frame: After the 6-week intervention period
Compliance defined as the quality of the the IWT sessions
3 secondary outcomes
Glycemic control
Time frame: 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 fitness
Time frame: Before and after the 6-week intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IWT-group in people with Gestational Diabetes Mellitus in Pregnancy, run by The Danish Center for Strategic Research on Type 2 Diabetes at 1 site in Denmark.
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 4 inclusion and 5 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 26 Jul 2018. 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 Denmark. 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?
Compliance to the prescribed IWT-intervention (time frame: After the 6-week intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2018.