NCT01247753: WENDY

Walking Exercise and Nutrition to Reduce Diabetes Risk for You (WENDY)

Completed NA Last updated 23 May 2017

What this trial tests

NA trial testing Walking group in Diabetes in 60 participants. Completed in 1 March 2012.

Timeline

1 March 2011

Primary endpoint
1 March 2012

1 March 2012

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	60
Start date	1 March 2011
Primary completion	1 March 2012
Estimated completion	1 March 2012
Sites	1 location across Australia

Drugs / interventions tested

• Walking group

Conditions studied

• Diabetes — all drugs for Diabetes →
• Gestational Diabetes Mellitus — all drugs for Gestational Diabetes Mellitus →

Sponsor

University of Michigan

Who can join

18 and older, female only, with Diabetes or Gestational Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The prevalence of Gestational Diabetes Mellitus (GDM) in Australia is approximately 5%-8%, with up to one third of all parous women who develop type 2 diabetes having a previous history of GDM. Research to determine strategies to delay or prevent the development of or progression to diabetes is vital, particularly in population groups that are at higher risk, such as GDM, and overweight women (BMI\>=25). Currently, follow-up or post-partum support for women who develop GDM is limited to advice to complete a 6 week post-partum oral glucose tolerance test to exclude overt diabetes, to be repeated annually. A pilot randomized controlled trial (RCT) conducted at Mater Mothers Hospital suggested that a post-partum intervention designed to increase physical activity in women with previous GDM may be feasible. A recent study in the United States recruited women with recent GDM into an RCT where the control group received usual care and the intervention group received a web based walking program. Although the results of this study are limited, they did show an increase in pedometer steps/day between baseline and end of study. Dietary intervention has been proven to increase probability of weight loss, so a strategy of combining both a pedometer and nutrition based program may prove to be more successful for long term improvement of a healthy lifestyle to prevent type 2 diabetes.

Study hypothesis: A pedometer based intervention to encourage physical activity, combined with nutrition coaching in women with recent GDM and BMI \>= 25 will result in increased weight loss, improved insulin sensitivity and increased physical activity when compared with standard care.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.