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

NCT01247753 | Completed

• 2 other identifiers: K23 DK71552-1K23DK071552
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Gestational Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  pre-post

Secondary Outcomes (2)

• Change in insulin sensitivity

  pre-post

• Change in physical activity

  pre-post

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Walking group

Control

NO INTERVENTION

Interventions

Walking group BEHAVIORAL

Internet-mediated pedometer-based walking program with gradually increasing step count goals and feedback on step counts. Also includes nutritional coaching course consisting of 1 individual session with a dietician, 4 group sessions, and monthly follow-up. Oral glucose tolerance tests pre and post-intervention.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of gestational diabetes mellitus and given birth in the preceding 6 months to 3 years; 18 years of age or older; BMI \>= 25; Routine access to a computer; Adequate computer skills to navigate websites and email; Speak and understand English well enough to participate in the study

You may not qualify if:

• Currently pregnant or planning to become pregnant in the next year; Current diabetes; Currently taking medications that interfere with glucose metabolism

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Mater Mothers' Hospital: collaborator

Study Sites (1)

Mater Mothers Hospital

South Brisbane, Queensland, 4101, Australia

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 24, 2010
• Study Start: March 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 23, 2017

Record last verified: 2017-05

Locations

AU (1)