Diet and Exercise for Underserved Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of South Carolina
ClinicalTrials.gov Identifier:
NCT01172340
First received: July 28, 2010
Last updated: February 2, 2012
Last verified: February 2012

July 28, 2010
February 2, 2012
August 2007
November 2011   (final data collection date for primary outcome measure)
  • body weight [ Time Frame: one year ] [ Designated as safety issue: No ]
    body weight in pounds is measured at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
  • waist circumference [ Time Frame: one year ] [ Designated as safety issue: No ]
    waist circumference in centimeters is measured at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
Same as current
Complete list of historical versions of study NCT01172340 on ClinicalTrials.gov Archive Site
  • dietary fat intake [ Time Frame: one year ] [ Designated as safety issue: No ]
    total dietary fat intake in grams and % of energy intake is assessed via 3-day dietary recall interviews at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
  • saturated dietary fat intake [ Time Frame: one year ] [ Designated as safety issue: No ]
    Saturated fat intake in grams and % of energy intake is measured via 3-day dietary recall interviews at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
  • fruit and vegetable intake [ Time Frame: one year ] [ Designated as safety issue: No ]
    Average daily servings of fruit and vegetables is measured via 3-day dietary recall interviews at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
  • dietary fiber intake [ Time Frame: one year ] [ Designated as safety issue: No ]
    Average daily intake of dietary fiber in grams is measured via 3-day dietary recall interviews at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
  • total energy intake [ Time Frame: one year ] [ Designated as safety issue: No ]
    Total energy intake in kcals is measured via 3-day dietary recall interviews at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
  • physical activity level [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Time spent in light, moderate and vigorous physical activity is estimated from 7 days of accelerometer wear at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
  • social support [ Time Frame: one year ] [ Designated as safety issue: No ]
    Social support for healthy eating and exercise is measure via interview at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
  • healthy eating behaviors [ Time Frame: one year ] [ Designated as safety issue: No ]
    Healthy eating behaviors are measured with a validated scaled via interviews at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
  • exercise self-efficacy [ Time Frame: one year ] [ Designated as safety issue: No ]
    Exercise self-efficacy is measured via a validated scale by interview at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
Same as current
Not Provided
Not Provided
 
Diet and Exercise for Underserved Women
Behavioral/Support Intervention for Diet and Exercise Among Underserved Women

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.

Overweight and obesity disproportionately impact economically disadvantaged and minority women. Overweight and obese women ages 25 to 50 are recruited from Census tracts with 25% or more residents living below poverty-level income. A skills-based intervention was designed with input from women in these communities gathered via focus groups and from a community advisory board. The intervention activities and strategies take into consideration the social and economic challenges of women with limited income, competing demands on their time and cultural beliefs about food preferences and body image.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Obesity
  • Behavioral: Behavioral and support intervention
    Individual counseling session with diet and exercise recommendations, 16 weekly group sessions, 8 weeks of followup phone support
  • Behavioral: Wait-listed control group
    Controls receive the same individual counseling session as intervention group; receive mailed health information; are offered group sessions after last post-measure
  • Experimental: Behavioral and support intervention
    one individual counseling session with diet and exercise recommendations plus 16 weeks of group sessions, plus 8 weeks of phone followup
    Intervention: Behavioral: Behavioral and support intervention
  • Placebo Comparator: wait-listed control group
    Controls receive individual counseling session and recommendations, mailed health information, and after post-test measures are offered an abbreviated group-based intervention
    Intervention: Behavioral: Wait-listed control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
December 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 25-50 years of age
  • live in Census tracts with 25% or more below poverty in Columbia, SC
  • waist circumference >88 cm

Exclusion Criteria:

  • insulin-dependent
  • pregnant
  • moderate exercise contraindicated
  • not in control of food choices [institutional setting or restricted diet]
  • uncontrolled hypertension
  • weight >430 pounds
Female
25 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01172340
R01DK074666
Yes
University of South Carolina
University of South Carolina
Not Provided
Principal Investigator: Patricia A Sharpe, PhD, MPH University of South Carolina
University of South Carolina
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP