Patients Navigators in Facilitating Weight Management in Obese Participants

Not Applicable

Active, not recruiting

• Conditions: Obesity; Health Status Unknown
• Interventions: Other: Informational Intervention; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention

• Registration Number: NCT03674229
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

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 Timeline

• Study Start: 2015-07-02
• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10
• Primary Completion: 2030-10-01
• Study Completion: 2030-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 171

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.)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (information about weight management programs)	Questionnaire Administration	Participants receive information about commercially-available weight management programs and encouragement to participate in one of the programs for 6 months.
Group II (information, call from patient navigator)	Informational Intervention	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 II (information, call from patient navigator)	Telephone-Based Intervention	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 II (information, call from patient navigator)	Questionnaire Administration	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 I (information about weight management programs)	Informational Intervention	Participants receive information about commercially-available weight management programs and encouragement to participate in one of the programs for 6 months.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Positive change in physical activity	Baseline up to 6 months	Accelerometer data will provide an objective assessment of physical activity (PA) We will calculate minutes of PA per week and meeting recommendations (yes/no).
Measurement of fruit and vegetable consumption	Baseline up to 6 months	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.
Participant attendance or use of evidence-based weight management programs	Up to 6 months	Attendance is a continuous variable and is defined as the total number of self-reported sessions attended or used by each participant.
Objectively measured weight change.	Baseline up to 6 months	Change in body weight from baseline will be calculated.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States