Postpartum Weight Loss and Exercise (PRIDE)

Pennington Biomedical Research Center

Status: Completed

Conditions: Gestational Diabetes; Glucose Intolerance

Treatments: Behavioral: Telehelath Group; Behavioral: Face to face; Behavioral: Non-intervention group

Study type: Interventional

Funder types: Other

Identifiers

NCT01296516

PBRC 10041

Details and patient eligibility

About

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.

Full 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

Enrollment: 7 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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7 participants in 3 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Non-intervention group

Face-to-face group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Face to face

Telehealth Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Telehelath Group