Patients Navigators in Facilitating Weight Management in Obese Participants

N/AActive Not RecruitingNCT03674229

M.D. Anderson Cancer Center171 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

171

Conditions

Health Status Unknown Obesity

Interventions

Informational InterventionOTHER

Receive information about weight management programs

Questionnaire AdministrationOTHER

Ancillary studies

Telephone-Based InterventionBEHAVIORAL

Receive phone calls from an assigned patient navigator

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 6 months

Secondary Outcomes

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.

Time frame: 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).

Time frame: 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.

Time frame: Baseline up to 6 months

Objectively measured weight change.

Change in body weight from baseline will be calculated.

Time frame: Baseline up to 6 months

Data from ClinicalTrials.gov

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