Interval Walking Intervention for Pregnant Women Diagnosed With Gestational Diabetes Mellitus

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03229161
• Other study ID #: CT20160156
• Secondary ID: S-2016015616/405
• Status: Completed
• Phase: N/A
• Start date: January 3, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: July 2018
• Source: The Danish Center for Strategic Research on Type 2 Diabetes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: May 1, 2018
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics

Intervention

Behavioral:
• IWT-group

Locations

Country	Name	City	State
Denmark	Danish Centre of strategic research of type 2 diabetes	Odense

Sponsors (2)

Lead Sponsor	Collaborator
The Danish Center for Strategic Research on Type 2 Diabetes	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood pressure	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
Other	Physical and mental health	Perceived physical and mental health was measured using the SF-12 questionnaire.	Before and after the 6-week intervention period
Other	BMI	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
Primary	Compliance to the prescribed IWT-intervention	Compliance defined as adherence to the prescribed IWT-intervention	After the 6-week intervention period
Primary	Compliance to the prescribed IWT-intervention	Compliance defined as the quality of the the IWT sessions	After the 6-week intervention period
Secondary	Glycemic control	Blood glucose variations measured by 48-hour continuous glucose monitoring	Before and after the 6-week intervention period
Secondary	Physical activity level	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
Secondary	Physical fitness	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