Interval Walking Intervention for Pregnant Women Diagnosed With Gestational Diabetes Mellitus

NCT03229161 | Completed DMC

• 3 other identifiers: CT20160156S-2016015616/40511
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Glycemic control

  Before and after the 6-week intervention period

• Physical activity level

  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

  Before and after the 6-week intervention period

Other Outcomes (3)

• Blood pressure

  Before and after the 6-week intervention period

• Physical and mental health

  Before and after the 6-week intervention period

• BMI

  Before and after the 6-week intervention period

Study Arms (2)

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.

Behavioral: IWT-group

Con-group

NO INTERVENTION

The con-group follows the standardized GDM care program for GDM patients at OUH

Interventions

IWT-group BEHAVIORAL

IWT-group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: As only women can be diagnosed with gestational diabetes mellitus, only women are eligible in participating in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The Danish Center for Strategic Research on Type 2 Diabetes: lead
• Odense University Hospital: collaborator

Study Sites (1)

Danish Centre of strategic research of type 2 diabetes

Odense, 5000, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 25, 2017
• Study Start: January 3, 2017
• Primary Completion: May 31, 2017
• Study Completion: May 1, 2018
• Last Updated: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)