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FirstWIND: Weight Loss Interventions After Delivery

This study has been completed.
Sponsor:
Collaborator:
American Diabetes Association
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00377026
First received: September 13, 2006
Last updated: June 18, 2009
Last verified: June 2009
  Purpose

This a pilot intervention study in which postpartum women will be randomized to receive a 6-month postpartum weight loss intervention or usual care.


Condition Intervention
Overweight
Obesity
Behavioral: lifestyle intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: FirstWIND: Weight Loss Interventions After Delivery

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • weight loss [ Time Frame: baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • health status [ Time Frame: baseline and six months ] [ Designated as safety issue: No ]
  • body mass index [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lifestyle
participants receive lifestyle intervention
Behavioral: lifestyle intervention
Lifestyle modification including individual sessions with an interventionist to discuss dietary intake and exercise. Group sessions with other participants randomized to the lifestyle intervention to discuss lifestyle modification and group exercise.

Detailed Description:

Overweight and obesity affect over 15 million adult women in the United States. Postpartum weight retention has been shown to be one factor contributing to weight retention, obesity and possible development of type 2 diabetes. African-American women and other minority women are at especially high risk for the development of obesity and type 2 diabetes. We propose to pilot a six-month postpartum-specific lifestyle intervention among urban-based, postpartum African-American women.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postpartum women with a pre-pregnancy or first trimester body mass index of 28 or greater or a history of gestational diabetes in the most recent pregnancy.

Exclusion Criteria:

  • Current cardiac disease or serious chronic disease, including cancer.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377026

Locations
United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
American Diabetes Association
Investigators
Principal Investigator: Wanda Nicholson, MD, MPH Johns Hopkins School of Medicine
  More Information

No publications provided

Responsible Party: Wanda Nicholson, MD, MPH, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00377026     History of Changes
Other Study ID Numbers: M051633
Study First Received: September 13, 2006
Last Updated: June 18, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
weight loss
postpartum
weight retention

Additional relevant MeSH terms:
Overweight
Weight Loss
Body Weight
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014