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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01819 | Other Identifier | NCI-CTRP Clinical Trials Registry |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (information about weight management programs) | Active Comparator | Participants receive information about commercially-available weight management programs and encouragement to participate in one of the programs for 6 months. |
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| Group II (information, call from patient navigator) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Informational Intervention | Other | Receive information about weight management programs |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Positive change in physical activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorna McNeill | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31722544 | Derived | 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. |
| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Questionnaire Administration | Other | Ancillary studies |
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| Telephone-Based Intervention | Behavioral | Receive phone calls from an assigned patient navigator |
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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 |
| 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 |
| Objectively measured weight change. | Change in body weight from baseline will be calculated. | Baseline up to 6 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |