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Patients Navigators in Facilitating Weight Management in Obese Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674229
Recruitment Status : Active, not recruiting
First Posted : September 17, 2018
Last Update Posted : October 2, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Health Status Unknown Obesity Other: Informational Intervention Other: Questionnaire Administration Behavioral: Telephone-Based Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Using Patient Navigators to Facilitate Weight Management Among Adults
Actual Study Start Date : July 2, 2015
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Active Comparator: 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.
Other: Informational Intervention
Receive information about weight management programs

Other: Questionnaire Administration
Ancillary studies

Experimental: 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.
Other: Informational Intervention
Receive information about weight management programs

Other: Questionnaire Administration
Ancillary studies

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Participant attendance or use of evidence-based weight management programs [ Time Frame: 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.

  2. Positive change in physical activity [ Time Frame: 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).

  3. Measurement of fruit and vegetable consumption [ Time Frame: 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.

  4. Objectively measured weight change. [ Time Frame: Baseline up to 6 months ]
    Change in body weight from baseline will be calculated.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674229


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Lorna McNeill M.D. Anderson Cancer Center
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03674229    
Other Study ID Numbers: 2015-0255
NCI-2018-01819 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2015-0255 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
UL1TR000371 ( U.S. NIH Grant/Contract )
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No