Postpartum Weight Loss and Exercise (PRIDE)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Gestational Diabetes Glucose Intolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control Group

A group matched for age and BMI will be selected to serve as control subjects in this study.

Group Type PLACEBO_COMPARATOR

Non-intervention group

Intervention Type BEHAVIORAL

A pedometer and written material on a healthy lifestyle.

Face-to-face group

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.

Group Type ACTIVE_COMPARATOR

Face to face

Intervention Type BEHAVIORAL

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

Telehealth Group

Participants randomized to the Telehealth intervention will receive behavioral counseling through Trestletree, phone system.

Group Type ACTIVE_COMPARATOR

Telehelath Group

Intervention Type BEHAVIORAL

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

Interventions

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Non-intervention group

A pedometer and written material on a healthy lifestyle.

Intervention Type BEHAVIORAL

Face to face

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

Intervention Type BEHAVIORAL

Telehelath Group

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Placebo Trestletree

Eligibility Criteria

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Inclusion Criteria

* Postpartum Women ≥18 years to 45 years (inclusive) of age who experienced GDM during index pregnancy
* English-speaking

Exclusion Criteria

* Women enrolled in COPSS-GDM will be excluded if they met the following 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
* History or clinical manifestation of any eating disorder
* Smoking
* Pregnancy or pregnancy planned during the coming year
* Unwilling or unable to adhere to the clinical evaluation schedule over the twelve -month study period

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No