Clinical trial NCT01296516: Postpartum Weight Loss and Exercise (PRIDE)
Official title: Early Postpartum Treatment of Gestational Diabetes With Weight Loss and Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Glucose Intolerance
Keywords: Women
Postpartum
GDM
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: THE C.B. AND IRENE PENNINGTON FOUNDATION
First posted: 2011-02-15
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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:

1. decrease body weight and
2. reduce the rate of metabolic abnormalities, 12 months after delivery

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

Primary outcomes:
measure: Incidence of glucose intolerance
timeFrame: 8 Months
Secondary outcomes:
measure: Weight loss
timeFrame: 8 months
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Leanne M. Redman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Womans' Research Hospital
name: Karen Elkind-Hirsh, PhD
role: STUDY_DIRECTOR
affiliation: Pennington Biomedical Research Center
name: Catherine Chamagne, PhD
role: STUDY_CHAIR
affiliation: Pennington Biomedical Research Center
name: Timothy S. Church, MD, MPH, PhD
role: STUDY_CHAIR
affiliation: Pennington Biomedical Reserach Center
name: Eric Ravussin, PhD
role: STUDY_CHAIR
References: