Interval Walking Intervention for Pregnant Women Diagnosed With Gestational Diabetes Mellitus

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: Completed
• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Behavioral: IWT-group

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: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Compliance to the prescribed IWT-intervention	Compliance defined as adherence to the prescribed IWT-intervention	After the 6-week intervention period
Compliance to the prescribed IWT-intervention	Compliance defined as the quality of the the IWT sessions	After the 6-week intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic control	Blood glucose variations measured by 48-hour continuous glucose monitoring	Before and after the 6-week intervention period
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Physical and mental health	Perceived physical and mental health was measured using the SF-12 questionnaire.	Before and after the 6-week intervention period
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

Collaborators and Investigators

• Sponsor: The Danish Center for Strategic Research on Type 2 Diabetes
• Collaborators: Odense University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 3, 2017
• Primary Completion (ACTUAL): May 31, 2017
• Study Completion (ACTUAL): May 1, 2018

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (ACTUAL): July 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID 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