Postpartum Weight Loss and Exercise (PRIDE)

Pennington Biomedical Research Center7 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Gestational Diabetes Glucose Intolerance

Interventions

Non-intervention groupBEHAVIORAL

A pedometer and written material on a healthy lifestyle.

Face to faceBEHAVIORAL

Motivational meetings held once per week; Behavioral sessions weill be led by a trained interventionist.

Telehelath GroupBEHAVIORAL

Participants will speak to Trestletree personnel once a week via phone.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Outcomes

Primary Outcomes

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.

Time frame: 8 Months

Secondary Outcomes

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

Time frame: 8 months

Data from ClinicalTrials.gov

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