Diet and Exercise for Underserved Women
Behavioral/Support Intervention for Diet and Exercise Among Underserved Women
1 other identifier
interventional
180
1 country
1
Brief Summary
The purpose is to determine if a culturally tailored diet and exercise intervention of 16 weekly sessions with 8 weeks of followup phone support is effective in reducing waist circumference, weight, and related diet and exercise behaviors among women from underserved communities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Aug 2007
Longer than P75 for not_applicable obesity
1 active site
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
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 28, 2010
CompletedFirst Posted
Study publicly available on registry
July 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedApril 22, 2019
April 1, 2019
4.3 years
July 28, 2010
April 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
body weight
body weight in pounds is measured at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
one year
waist circumference
waist circumference in centimeters is measured at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
one year
Secondary Outcomes (9)
dietary fat intake
one year
saturated dietary fat intake
one year
fruit and vegetable intake
one year
dietary fiber intake
one year
total energy intake
one year
- +4 more secondary outcomes
Study Arms (2)
Behavioral and support intervention
EXPERIMENTALone individual counseling session with diet and exercise recommendations plus 16 weeks of group sessions, plus 8 weeks of phone followup
wait-listed control group
PLACEBO COMPARATORControls receive individual counseling session and recommendations, mailed health information, and after post-test measures are offered an abbreviated group-based intervention
Interventions
Individual counseling session with diet and exercise recommendations, 16 weekly group sessions, 8 weeks of followup phone support
Controls receive the same individual counseling session as intervention group; receive mailed health information; are offered group sessions after last post-measure
Eligibility Criteria
You may qualify if:
- years of age
- live in Census tracts with 25% or more below poverty in Columbia, SC
- waist circumference \>88 cm
You may not qualify if:
- insulin-dependent
- pregnant
- moderate exercise contraindicated
- not in control of food choices \[institutional setting or restricted diet\]
- uncontrolled hypertension
- weight \>430 pounds
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prevention Research Center, University of South Carolina
Columbia, South Carolina, 29208, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia A Sharpe, PhD, MPH
University of South Carolina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Professor and Co-Investigator
Study Record Dates
First Submitted
July 28, 2010
First Posted
July 29, 2010
Study Start
August 1, 2007
Primary Completion
November 1, 2011
Study Completion
December 1, 2011
Last Updated
April 22, 2019
Record last verified: 2019-04