Health Status UnknownNCT03674229
Patients Navigators in Facilitating Weight Management in Obese Participants
A study testing Informational Intervention, Questionnaire Administration and Telephone-Based Intervention in people with Health Status Unknown and Obesity, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Status Unknown, Obesity
- What is being tested?
- Informational Intervention, Questionnaire Administration and Telephone-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2015to 1 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Patient Navigators to Facilitate Weight Management Among Adults
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the effectiveness of patient navigators to increase enrollment in evidence-based weight management programs.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Health Status Unknown, Obesity
- Being tested
- Informational Intervention, Questionnaire Administration, Telephone-Based Intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informational InterventionOther
Receive information about weight management programs
Questionnaire AdministrationOther
Ancillary studies
Telephone-Based InterventionBehavioural
Receive phone calls from an assigned patient navigator
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Informational Intervention; Other: Questionnaire Administration |
| 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. Receives: Other: Informational Intervention; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months
Secondary outcomes (4)
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.
Measured: Up to 6 months
Positive change in physical activity
Accelerometer data will provide an objective assessment of physical activity (PA) We will calculate minutes of PA per week and meeting recommendations (yes/no).
Measured: 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.
Measured: Baseline up to 6 months
Objectively measured weight change.
Change in body weight from baseline will be calculated.
Measured: Baseline up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start2 Jul 2015
- Primary completion1 Oct 2030 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Status UnknownStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lorna McNeill, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674229
- Sponsor's protocol ID
- 2015-0255
- Other IDs
- NCI-2018-01819
- Status last verified
- Oct 2026
- First submitted
- 10 Sep 2018
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31722544
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Patient Navigators to Facilitate Weight Management Among Adults
- ClinicalTrials.gov ID
- NCT03674229
- Acronym / sponsor ID
- 2015-0255
- Conditions
- Health Status Unknown, Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 171 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Jul 2015 (actual)
- Primary completion
- 1 Oct 2030 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the effectiveness of patient navigators to increase enrollment in evidence-based weight management programs.
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (information about weight management programs) | Active comparator | Other: Informational Intervention, Other: Questionnaire AdministrationParticipants receive information about commercially-available weight management programs and encouragement to participate in one of the programs for 6 months. |
| Group II (information, call from patient navigator) | Experimental | Other: Informational Intervention, Other: Questionnaire Administration, Behavioral: Telephone-Based InterventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informational InterventionReceive information about weight management programs | Other | Group I (information about weight management programs), Group II (information, call from patient navigator) |
| Questionnaire AdministrationAncillary studies | Other | Group I (information about weight management programs), Group II (information, call from patient navigator) |
| Telephone-Based InterventionReceive phone calls from an assigned patient navigator | Behavioural | Group II (information, call from patient navigator) |
Primary outcome
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.
4 secondary outcomes
Participant attendance or use of evidence-based weight management programs
Time frame: Up to 6 months
Positive change in physical activity
Time frame: Baseline up to 6 months
Measurement of fruit and vegetable consumption
Time frame: Baseline up to 6 months
Objectively measured weight change.
Time frame: Baseline up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Derived from this study: PubMed 31722544Heredia 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.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorna McNeill principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informational Intervention, Questionnaire Administration and Telephone-Based Intervention in people with Health Status Unknown and Obesity, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in participant enrollment in evidence-based weight management programs (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03674229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.