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Completed

NCT Number: NCT01172340

Diet and Exercise for 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.

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Key information

Conditions

Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Prevention Research Center, University of South Carolina

Columbia, South Carolina, 29208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral and support intervention

Behavioral

Individual counseling session with diet and exercise recommendations, 16 weekly group sessions, 8 weeks of followup phone support

Wait-listed control group

Behavioral

Controls receive the same individual counseling session as intervention group; receive mailed health information; are offered group sessions after last post-measure

Primary outcomes

  1. body weight

    Time frame: one year

    body weight in pounds is measured at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.

  2. waist circumference

    Time frame: one year

    waist circumference in centimeters is measured at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.

Secondary outcomes

  1. dietary fat intake

    Time frame: one year

    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.

  2. saturated dietary fat intake

    Time frame: one year

    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.

  3. fruit and vegetable intake

    Time frame: one year

    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.

  4. dietary fiber intake

    Time frame: one year

    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.

  5. total energy intake

    Time frame: one year

    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.

  6. physical activity level

    Time frame: one year

    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.

  7. social support

    Time frame: one year

    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.

  8. healthy eating behaviors

    Time frame: one year

    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.

  9. exercise self-efficacy

    Time frame: one year

    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.

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Official study title

Behavioral/Support Intervention for Diet and Exercise Among Underserved Women

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jul 29, 2010
Registry last updated
Apr 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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