Health Status Unknown, Obesity
Conditions
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.
Interventions
OTHERInformational Intervention
Receive information about weight management programs
OTHERQuestionnaire Administration
Ancillary studies
BEHAVIORALTelephone-Based Intervention
Receive phone calls from an assigned patient navigator
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in participant enrollment in evidence-based weight management programs | Up to 6 months | We will compare differences in the proportion of self-reported enrollment in any program between intervention and control groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant attendance or use of evidence-based weight management programs | 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. |
| Positive change in physical activity | 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). |
| Measurement of fruit and vegetable consumption | 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. |
| Objectively measured weight change. | Baseline up to 6 months | Change in body weight from baseline will be calculated. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLorna McNeill
M.D. Anderson Cancer Center
Outcome results
None listed