North Carolina WISEWOMAN: Weight-Wise Pilot Study
North Carolina WISEWOMAN Study - Weight-Wise Program
1 other identifier
interventional
151
1 country
1
Brief Summary
The purpose of this study is to test the effectiveness of a weight loss and weight loss maintenance intervention among low income women, conducted in a community health center setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2005
Typical duration for not_applicable
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
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 6, 2006
CompletedFirst Posted
Study publicly available on registry
February 7, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedJune 10, 2010
June 1, 2010
2.2 years
February 6, 2006
June 9, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
body weight
4 months
Study Arms (2)
1
EXPERIMENTALSpecial Intervention
2
EXPERIMENTALDelayed intervention
Interventions
Eligibility Criteria
You may qualify if:
- Women 40-64 years old
- Gross income less than or equal to 200% federal poverty level
- BMI 25-45 inclusive
- Permission of health care provider if present with diabetes or previous CVD event
- English speaking
You may not qualify if:
- Medical condition for which weight loss is contraindicated, e.g. malignancy or other serious illness
- CVD event in past 3 months
- Self-reported history of renal disease
- Weight loss greater than 20 lbs in last 3 months
- Any history of gastric bypass surgery, stomach stapling or liposuction
- Planning to leave area before study period ends
- Current participation in another clinical trial
- Pregnant, breastfeeding or planning a pregnancy before the end of the study
- Current use of medications to treat psychosis or manic-depressive illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New Hanover Community Health Center
Wilmington, North Carolina, 28401, United States
Related Publications (2)
Samuel-Hodge CD, Johnston LF, Gizlice Z, Garcia BA, Lindsley SC, Gold AD, Braxton DF, Keyserling TC. A pilot study comparing two weight loss maintenance interventions among low-income, mid-life women. BMC Public Health. 2013 Jul 15;13:653. doi: 10.1186/1471-2458-13-653.
PMID: 23855318DERIVEDSamuel-Hodge CD, Johnston LF, Gizlice Z, Garcia BA, Lindsley SC, Bramble KP, Hardy TE, Ammerman AS, Poindexter PA, Will JC, Keyserling TC. Randomized trial of a behavioral weight loss intervention for low-income women: the Weight Wise Program. Obesity (Silver Spring). 2009 Oct;17(10):1891-9. doi: 10.1038/oby.2009.128. Epub 2009 Apr 30.
PMID: 19407810DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carmen Samuel-Hodge, PhD, RD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 6, 2006
First Posted
February 7, 2006
Study Start
February 1, 2005
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
June 10, 2010
Record last verified: 2010-06