Using Patient Navigators to Facilitate Weight Management Among Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 171
- Locations
- 1
- Primary Endpoint
- Change in participant enrollment in evidence-based weight management programs
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Informational Intervention (Other)
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.
Intervention: Questionnaire Administration (Other)
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.
Intervention: Informational Intervention (Other)
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.
Intervention: Questionnaire Administration (Other)
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.
Intervention: Telephone-Based Intervention (Behavioral)
Outcomes
Primary Outcomes
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 Outcomes
- Positive change in physical activity(Baseline up to 6 months)
- Measurement of fruit and vegetable consumption(Baseline up to 6 months)
- Participant attendance or use of evidence-based weight management programs(Up to 6 months)
- Objectively measured weight change.(Baseline up to 6 months)