Patients Navigators in Facilitating Weight Management in Obese Participants

• ClinicalTrials.gov Identifier: NCT03674229
• Recruitment Status: Unknown
• First Posted: September 17, 2018
• Last Update Posted: October 2, 2019
• Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Health Status Unknown; Obesity	Other: Informational Intervention; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 171 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Using Patient Navigators to Facilitate Weight Management Among Adults
• Actual Study Start Date: July 2, 2015
• Estimated Primary Completion Date: October 1, 2020
• Estimated Study Completion Date: October 1, 2021

Arms and Interventions

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: Informational Intervention; Receive information about weight management programs; Other: Questionnaire Administration; Ancillary studies
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: Informational Intervention; Receive information about weight management programs; Other: Questionnaire Administration; Ancillary studies; Behavioral: Telephone-Based Intervention; Receive phone calls from an assigned patient navigator

Outcome Measures

Primary Outcome Measures :

1. Change in participant enrollment in evidence-based weight management programs [ Time Frame: 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 :

1. Participant attendance or use of evidence-based weight management programs [ Time Frame: 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.
2. Positive change in physical activity [ Time Frame: 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).
3. Measurement of fruit and vegetable consumption [ Time Frame: 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.
4. Objectively measured weight change. [ Time Frame: Baseline up to 6 months ]
   Change in body weight from baseline will be calculated.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Texas

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Lorna McNeill; M.D. Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center Website 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT03674229
• Other Study ID Numbers: 2015-0255; NCI-2018-01819 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 2015-0255 ( Other Identifier: M D Anderson Cancer Center ); P30CA016672 ( U.S. NIH Grant/Contract ); UL1TR000371 ( U.S. NIH Grant/Contract )
• First Posted: September 17, 2018
• Last Update Posted: October 2, 2019
• Last Verified: October 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No