Clinical trial NCT01247753: Walking Exercise and Nutrition to Reduce Diabetes Risk for You (WENDY)
Official title: Stepping Up to Health - Walking Exercise and Nutrition to Reduce Diabetes Risk for You (WENDY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Gestational Diabetes Mellitus
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Mater Mothers' Hospital
First posted: 2010-11-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in body weight
timeFrame: pre-post
Secondary outcomes:
measure: Change in insulin sensitivity
timeFrame: pre-post
measure: Change in physical activity
timeFrame: pre-post
Other outcomes:
Locations:
city: South Brisbane
country: Australia
facility: Mater Mothers Hospital
state: Queensland
Study officials:
References: