Patients Navigators in Facilitating Weight Management in Obese Participants

Obesity Clinical Trial

Official title:

Using Patient Navigators to Facilitate Weight Management Among Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03674229
• Other study ID #: 2015-0255
• Secondary ID: NCI-2018-0181920
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2, 2015
• Est. completion date: October 1, 2030

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 171
• Est. completion date: October 1, 2030
• Est. primary completion date: October 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Status Unknown
• Obesity

Intervention

Other:
• Informational Intervention
Receive information about weight management programs
• Questionnaire Administration
Ancillary studies

Behavioral:
• Telephone-Based Intervention
Receive phone calls from an assigned patient navigator

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Objectively measured weight change.	Change in body weight from baseline will be calculated.	Baseline up to 6 months

External Links

•   MD Anderson Cancer Center Website