Diet and Exercise for Underserved Women

NCT ID: NCT01172340

Last Updated: 2019-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2011-12-31

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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Behavioral and support intervention

Intervention Type BEHAVIORAL

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

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

Group Type PLACEBO_COMPARATOR

Wait-listed control group

Intervention Type BEHAVIORAL

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

Interventions

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Behavioral and support intervention

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

Intervention Type 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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Patricia Sharpe

Research Professor and Co-Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patricia A Sharpe, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Locations

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Prevention Research Center, University of South Carolina

Columbia, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00003053

Identifier Type: -

Identifier Source: org_study_id

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