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
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Behavioral and support intervention
Behavioral: Wait-listed control group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Behavioral/Support Intervention for Diet and Exercise Among Underserved Women

Resource links provided by NLM:


Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 180
Study Start Date: August 2007
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Behavioral: Behavioral and support intervention
Individual counseling session with diet and exercise recommendations, 16 weekly group sessions, 8 weeks of followup phone support
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
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172340

Locations
United States, South Carolina
Prevention Research Center, University of South Carolina
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
Investigators
Principal Investigator: Patricia A Sharpe, PhD, MPH University of South Carolina
  More Information

Additional Information:
No publications provided

Responsible Party: University of South Carolina
ClinicalTrials.gov Identifier: NCT01172340     History of Changes
Other Study ID Numbers: R01DK074666
Study First Received: July 28, 2010
Last Updated: February 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Carolina:
behavioral
diet
exercise

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014