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NCT Number: NCT03674229

Patients Navigators in Facilitating Weight Management in Obese Participants

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Health Status Unknown Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Informational intervention

Other

Receive information about weight management programs

Questionnaire Administration

Other

Ancillary studies

Telephone-Based Intervention

Behavioral

Receive phone calls from an assigned patient navigator

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Using Patient Navigators to Facilitate Weight Management Among Adults

Important dates

Study start
2015
Primary completion
2030
Study completion
2030
First posted
Sep 17, 2018
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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