Patients Navigators in Facilitating Weight Management in Obese Participants

Using Patient Navigators to Facilitate Weight Management Among Adults

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Health Status Unknown
• Intervention / Treatment: Other: Questionnaire Administration; Other: Informational Intervention; Behavioral: Telephone-Based Intervention

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 Type: Interventional
• Enrollment (Actual): 171
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Questionnaire Administration; Ancillary studies; Other: Informational Intervention; Receive information about weight management programs
Experimental: 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.	Other: Questionnaire Administration; Ancillary studies; Other: Informational Intervention; Receive information about weight management programs; Behavioral: Telephone-Based Intervention; Receive phone calls from an assigned patient navigator

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Lorna McNeill, M.D. Anderson Cancer Center

Publications and helpful links

General Publications

• Heredia NI, Fernandez ME, van den Berg AE, Durand CP, Kohl HW, Reininger BM, Hwang KO, McNeill LH. Coaction Between Physical Activity and Fruit and Vegetable Intake in Racially Diverse, Obese Adults. Am J Health Promot. 2020 Mar;34(3):238-246. doi: 10.1177/0890117119884479. Epub 2019 Nov 13.

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2015
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2015-0255 (Other Identifier: M D Anderson Cancer Center); P30CA016672 (U.S. NIH Grant/Contract); UL1TR000371 (U.S. NIH Grant/Contract); NCI-2018-01819 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No