Patients Navigators in Facilitating Weight Management in Obese Participants

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-02

Study Completion Date

2030-10-01

Brief Summary

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This trial studies the effectiveness of patient navigators in facilitating weight management in obese participants. Health coaches or patient navigators may help more participants take part in weight management programs.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To evaluate the effectiveness of patient navigators to increase enrollment in evidence-based weight management programs.

SECONDARY OBJECTIVES:

I. To evaluate the effectiveness of patient navigators to increase overall attendance or use of evidence-based weight management programs.

II. To evaluate the effectiveness of patient navigators to promoting and facilitating positive health behavior change: increased physical activity; improved diet; and weight loss.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive information about commercially-available weight management programs and encouragement to participate in one of the programs for 6 months.

GROUP II: Participants receive information about commercially-available weight management programs encouragement to participate in one of the programs for 6 months. Participants also receive 6 phone calls over 20-30 minutes each from an assigned patient navigator for 6 months.

After completion of the study, participants are followed up at 2 months.

Conditions

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Health Status Unknown 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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Group I (information about weight management programs)

Participants receive information about commercially-available weight management programs and encouragement to participate in one of the programs for 6 months.

Group Type ACTIVE_COMPARATOR

Informational Intervention

Intervention Type OTHER

Receive information about weight management programs

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Group II (information, call from patient navigator)

Participants receive information about commercially-available weight management programs encouragement to participate in one of the programs for 6 months. Participants also receive 6 phone calls over 20-30 minutes each from an assigned patient navigator for 6 months.

Group Type EXPERIMENTAL

Informational Intervention

Intervention Type OTHER

Receive information about weight management programs

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Telephone-Based Intervention

Intervention Type BEHAVIORAL

Receive phone calls from an assigned patient navigator

Interventions

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Informational Intervention

Receive information about weight management programs

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Telephone-Based Intervention

Receive phone calls from an assigned patient navigator

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Are referred by a University of Texas (UT) health care provider
* Have a body mass index (BMI) greater than or equal to 30 and less than or equal to 45 kg/m\^2
* Are able to read and speak English
* Have a working telephone number and address where materials can be mailed
* Able to engage in moderate intensity physical activity as determined by the Physical Activity Readiness Questionnaire (PAR-Q)
* Internet access at home or other location (e.g., work, church, library, community center, etc.)

Exclusion Criteria

* Another person in the same household already enrolled in the proposed intervention
* Pregnant or thinking about becoming pregnant during the study period
* Are already involved in another weight loss program
* Participated in a weight loss, exercise, or dietary modification program in the previous 6 months
* Involuntary or voluntary weight loss of greater than or equal to 5% body weight in the previous 6 months
* Are currently using weight loss medications

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No