Patient Navigator Program for Obesity

Overseen By Meghan L Butryn, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Drexel University

Must not be taking: Weight loss medication

Disqualifiers: Anorexia, Bulimia, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 12 months

68 Participants Needed

Trial Summary

What is the purpose of this trial?

Evidence-based interventions for overweight and obesity are underutilized. The utilization and efficacy of these interventions may improve with the implementation of a patient navigator program, as has been practiced in other fields (e.g., cancer). The proposed study will enroll adults ("index participants") (N=68) with overweight/obesity in a 12-month program in which they will be provided with a navigator who will help them understand their options for evidence-based weight loss intervention and who will promote initiation and continued engagement with an intervention option. The project will provide information about how well received the navigator program is and the extent to which it works as expected.

Eligibility Criteria

This trial is for adults with overweight or obesity issues. It's designed to help them understand and stick with weight loss programs. Specific eligibility details aren't provided, so it seems open to individuals who meet the general condition of having a weight management concern.

Inclusion Criteria

Reliable access to a device capable of using email and Drexel approved videoconferencing software

Agree that they will not join another intervention study in the WELL Center in the next 12 months

Successfully complete enrollment and assessments tasks, including connecting a wireless scale for baseline measurement of weight

Exclusion Criteria

A calculated weight suppression value of 10% or higher

Currently pregnant or planning to become pregnant in the next 12 months

I am currently using weight loss medication or other weight management methods.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive guidance from a navigator to initiate and adhere to an evidence-based weight loss intervention over 12 months

12 months

5-8 sessions via videoconferencing, monthly email contact

Follow-up

Participants are monitored for weight change and program acceptability

12 months

Assessments at 0, 6, and 12 months

Treatment Details

Interventions

• Navigator

Trial Overview The study tests a 'navigator' program over 12 months where participants are guided by a navigator to engage in evidence-based weight loss interventions and maintain their commitment.

Participant Groups

Group I: Navigator Intervention Experimental Treatment 1 Intervention

Participants assigned to the navigator condition will receive a weight loss counselor who they will maintain contact with over the 12 month period. Participants will attend 5-8 videoconferencing sessions with their navigator, as well as communicate with them monthly via email for extra support. Navigators will help participants initiate and adhere to an evidence-based weight loss intervention, without providing the treatment themselves.

Group II: Usual Care Active Control 1 Intervention

Participants assigned to the usual care condition will have no intervention contact during the 12-month data collection period and are encouraged to use resources available to them in community and in their health care system to identify treatment options. They will be given the option to attend a two-hour educational workshop (on videoconferencing software) after the 12-month assessment, to learn more about evidence-based approaches to weight loss.

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials

160

Recruited

48,600+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+