Clinical trial NCT03674229: Patients Navigators in Facilitating Weight Management in Obese Participants
Official title: Using Patient Navigators to Facilitate Weight Management Among Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Health Status Unknown
Obesity
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-09-17
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Change in participant enrollment in evidence-based weight management programs
timeFrame: Up to 6 months
Secondary outcomes:
measure: Participant attendance or use of evidence-based weight management programs
timeFrame: Up to 6 months
measure: Positive change in physical activity
timeFrame: Baseline up to 6 months
measure: Measurement of fruit and vegetable consumption
timeFrame: Baseline up to 6 months
measure: Objectively measured weight change.
timeFrame: Baseline up to 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lorna McNeill
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.