NCT03674229

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for not_applicable

Timeline
54mo left

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Jul 2015Oct 2030

Study Start

First participant enrolled

July 2, 2015

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2030

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

15.3 years

First QC Date

September 10, 2018

Last Update Submit

April 13, 2026

Conditions

Health Status UnknownObesity

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Participant attendance or use of evidence-based weight management programs

    Up to 6 months

  • Positive change in physical activity

    Baseline up to 6 months

  • Measurement of fruit and vegetable consumption

    Baseline up to 6 months

  • Objectively measured weight change.

    Baseline up to 6 months

Study Arms (2)

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.

Other: Informational InterventionOther: 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.

Other: Informational InterventionOther: Questionnaire AdministrationBehavioral: Telephone-Based Intervention

Interventions

Questionnaire AdministrationOTHER

Ancillary studies

Group I (information about weight management programs)Group II (information, call from patient navigator)
Telephone-Based InterventionBEHAVIORAL

Receive phone calls from an assigned patient navigator

Group II (information, call from patient navigator)
Informational InterventionOTHER

Receive information about weight management programs

Group I (information about weight management programs)Group II (information, call from patient navigator)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 31722544DERIVED

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lorna McNeill

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2018

First Posted

September 17, 2018

Study Start

July 2, 2015

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

October 1, 2030

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations

US(1)