Patients Navigators in Facilitating Weight Management in Obese Participants

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Obesity; Health Status Unknown

Treatments: Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention; Other: Informational Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03674229

2015-0255 (Other Identifier)

NCI-2018-01819 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 171 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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171 participants in 2 patient groups

Group I (information about weight management programs)

Active Comparator group

Description:

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

Treatment:

Other: Informational Intervention

Other: Questionnaire Administration

Group II (information, call from patient navigator)

Experimental group

Description:

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.

Treatment:

Other: Informational Intervention

Behavioral: Telephone-Based Intervention

Other: Questionnaire Administration