Postpartum Weight Loss and Exercise (PRIDE)

Study Overview
=================
Brief Summary
-----------------
The overall objective of this pilot project is to test in 50 women with a history of gestational diabetes mellitus (GDM), the effectiveness and feasibility of an 8 month intensive lifestyle intervention to reduce the rate of metabolic abnormalities within 1 year after delivery.

Detailed Description
-----------------
The objective is in comparison to a group of women not enrolled in the lifestyle intervention, 8 months of intensive lifestyle intervention aimed at promoting 7% weight loss through increased physical activity and dietary modification in women with a history of GDM will: decrease body weight and reduce the rate of metabolic abnormalities, 12 months after delivery

Official Title
-----------------
Early Postpartum Treatment of Gestational Diabetes With Weight Loss and Exercise

Conditions
-----------------
Gestational Diabetes, Glucose Intolerance

Intervention / Treatment
-----------------
* Behavioral: Non-intervention group
* Behavioral: Face to face
* Behavioral: Telehelath Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women are required to be enrolled (provided written consent for participation) in the COPSS-GDM study and therefore have met the following inclusion criteria: Postpartum Women ≥18 years to 45 years (inclusive) of age who experienced GDM during index pregnancy English-speaking Exclusion Criteria: Exclusion Criteria: Women enrolled in COPSS-GDM will be excluded if they met the following criteria: Medical Exclusion Criteria History or clinical manifestation of any other significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic disorders, or cancer Regular use of medications for weight control or psychosis Current use of medication to treat diabetes Psychiatric and Behavioral Exclusion Criteria History or clinical manifestation of any eating disorder Smoking History of drug or alcohol abuse (up to 14 drinks a week are allowed) within the past two years Other Exclusion Criteria Pregnancy or pregnancy planned during the coming year Unwilling or unable to adhere to the clinical evaluation schedule over the twelve -month study period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>A group matched for age and BMI will be selected to serve as control subjects in this study. | Behavioral: Non-intervention group<br>* A pedometer and written material on a healthy lifestyle.<br>* Other names: Placebo;|
| Active Comparator: Face-to-face group<br>Participants randomized to the face-to-face intervention will attend motivational meetings held once per week in Phase I and biweekly in Phase II. Behavioral sessions will be led by a trained interventionist and will take place at Pennington Biomedical Research Center. | Behavioral: Face to face<br>* Motivational meetings held once per week; Behavioral sessions weill be led by a trained interventionist.<br>|
| Active Comparator: Telehealth Group<br>Participants randomized to the Telehealth intervention will receive behavioral counseling through Trestletree, phone system. | Behavioral: Telehelath Group<br>* Participants will speak to Trestletree personnel once a week via phone.<br>* Other names: Trestletree;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of glucose intolerance | To examine the incidence of glucose abnormalities (impaired fasting glucose, impaired glucose tolerance, type 2 diabetes) and health outcomes (changes in body fat, waist circumference and blood lipids)in women with a history of gestational diabetes, 12 months postpartum. | 8 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Weight loss through increased physical activity and dietary modification will achieve similar results when delivered via face-to-face contact (DPP) or via telehealth | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Women, Postpartum, GDM