Patients Navigators in Facilitating Weight Management in Obese Participants

Study Overview
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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.

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.

Official Title
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Using Patient Navigators to Facilitate Weight Management Among Adults

Conditions
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Health Status Unknown, Obesity

Intervention / Treatment
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* Other: Informational Intervention
* Other: Questionnaire Administration
* Behavioral: Telephone-Based Intervention


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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 |
| --- | --- |
| Active Comparator: Group I (information about weight management programs)<br>Participants receive information about commercially-available weight management programs and encouragement to participate in one of the programs for 6 months. | Other: Informational Intervention<br>* Receive information about weight management programs<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Group II (information, call from patient navigator)<br>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. | Other: Informational Intervention<br>* Receive information about weight management programs<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Behavioral: Telephone-Based Intervention<br>* Receive phone calls from an assigned patient navigator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in participant enrollment in evidence-based weight management programs | We will compare differences in the proportion of self-reported enrollment in any program between intervention and control groups. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant attendance or use of evidence-based weight management programs | Attendance is a continuous variable and is defined as the total number of self-reported sessions attended or used by each participant. | Up to 6 months | 
| Positive change in physical activity | Accelerometer data will provide an objective assessment of physical activity (PA) We will calculate minutes of PA per week and meeting recommendations (yes/no). | Baseline up to 6 months | 
| Measurement of fruit and vegetable consumption | Fruit and vegetable consumption (i.e., # servings per day) will be measured using the 24 hour recall. Finally, objective measure of weight will be captured at each data collection time point. | Baseline up to 6 months | 
| Objectively measured weight change. | Change in body weight from baseline will be calculated. | Baseline up to 6 months |