NCT00288301

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

87
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2005

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

June 10, 2010

Status Verified

June 1, 2010

Enrollment Period

2.2 years

First QC Date

February 6, 2006

Last Update Submit

June 9, 2010

Conditions

Keywords

dietphysical activityweight management

Outcome Measures

Primary Outcomes (1)

  • body weight

    4 months

Study Arms (2)

1

EXPERIMENTAL

Special Intervention

Behavioral: Weight loss intervention

2

EXPERIMENTAL

Delayed intervention

Behavioral: Weight loss intervention

Interventions

weight loss intervention

12

Eligibility Criteria

Age40 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

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.

  • Samuel-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.

MeSH Terms

Conditions

OverweightObesityMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Carmen Samuel-Hodge, PhD, RD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

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

Locations