Diet and Exercise for Underserved Women

University of South Carolina

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Behavioral and support intervention; Behavioral: Wait-listed control group

Study type: Interventional

Funder types: Other

Identifiers

NCT01172340

Pro00003053

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: Female

Ages: 25 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups, including a placebo group

Behavioral and support intervention

Experimental group

Description:

one individual counseling session with diet and exercise recommendations plus 16 weeks of group sessions, plus 8 weeks of phone followup

Treatment:

Behavioral: Behavioral and support intervention

wait-listed control group

Placebo Comparator group

Description:

Controls receive individual counseling session and recommendations, mailed health information, and after post-test measures are offered an abbreviated group-based intervention

Treatment:

Behavioral: Wait-listed control group