NCT00377026

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

June 19, 2009

Status Verified

June 1, 2009

Enrollment Period

1.5 years

First QC Date

September 13, 2006

Last Update Submit

June 18, 2009

Conditions

OverweightObesity

Keywords

weight losspostpartumweight retention

Outcome Measures

Primary Outcomes (1)

  • weight loss

    baseline, 3 months, and 6 months

Secondary Outcomes (2)

  • health status

    baseline and six months

  • body mass index

    baseline, 3 months, 6 months

Study Arms (1)

lifestyle

EXPERIMENTAL

participants receive lifestyle intervention

Behavioral: lifestyle intervention

Interventions

lifestyle interventionBEHAVIORAL

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.

lifestyle

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Current cardiac disease or serious chronic disease, including cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

OverweightObesityWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Wanda Nicholson, MD, MPH

    Johns Hopkins School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2006

First Posted

September 15, 2006

Study Start

September 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

June 19, 2009

Record last verified: 2009-06

Locations

US(1)