Diet and Exercise for Underserved Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Behavioral/Support Intervention for Diet and Exercise Among Underserved Women

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Behavioral and support intervention
* Behavioral: Wait-listed control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral and support intervention<br>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<br>* Individual counseling session with diet and exercise recommendations, 16 weekly group sessions, 8 weeks of followup phone support<br>|
| Placebo Comparator: wait-listed control group<br>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<br>* Controls receive the same individual counseling session as intervention group; receive mailed health information; are offered group sessions after last post-measure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight | body weight in pounds is measured at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year. | one year | 
| waist circumference | waist circumference in centimeters is measured at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dietary fat intake | 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. | one year | 
| saturated dietary fat intake | 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. | one year | 
| fruit and vegetable intake | 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. | one year | 
| dietary fiber intake | 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. | one year | 
| total energy intake | 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. | one year | 
| physical activity level | 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. | one year | 
| social support | 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. | one year | 
| healthy eating behaviors | 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. | one year | 
| exercise self-efficacy | 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. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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behavioral, diet, exercise