Clinical trial

Piloting a Patient Navigator Program for Weight Loss

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06972381

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years

SexAll

Healthy volunteersAccepted

ConditionObesity, Overweight

Full registry criteria

Inclusion criteria include: * BMI \> 27 kg/m2 * weight \< 396 pounds due to limits of the wireless scale * age 18 to 75 * ability to read and speak English sufficiently to engage with a counselor and complete study measures * willing to be randomized to either study condition * willing to engage with a counselor for assistance in identifying and initiating a weight loss intervention * successfully complete enrollment and assessments tasks, including connecting a wireless scale for baseline measurement of weight * reliable access to a device capable of using email and Drexel approved videoconferencing software * residing in the greater Philadelphia metropolitan area, which includes Southeastern PA, Southern NJ, Northeast MD, and Northern DE * agree that they will not join another intervention study in the WELL Center in the next 12 months Exclusion criteria include: * a medical or psychiatric condition that may a) limit appropriateness of weight loss intervention or b) be likely to cause a change in weight in the next 12 months (e.g., anorexia nervosa, bulimia nervosa, end-stage kidney disease, some types of cancer) * currently taking weight loss medication or engaging in any other form of weight management intervention * history of bariatric surgery * a calculated weight suppression value of 10% or higher * currently pregnant or planning to become pregnant in the next 12 months * adults unable to consent, children, pregnant women, and prisoners

Treatments and study arms

Navigator

Behavioral

Participants in the navigator condition will meet with their counselor for sessions twice in month 1, once in month 2, once in month 4, and once in month 8. Three additional sessions may scheduled if desired by the participant. Navigators will assess treatment preferences, provide information about evidence-based treatment options for weight loss, aid in decision making, and facilitate action during the intervention initiation process. Following initiation of a weight loss treatment, navigators will also assess adherence to and acceptability of the selected weight loss intervention, and engage in problem solving and motivational enhancement to facilitate persistence with the original intervention or provide the support necessary for switching to an alternative intervention option. Additional intervention contact will include monthly emails over the 12 month period. Navigators will receive resource guides to help them tailor sessions to the individual participant.

Primary outcomes

Percent weight change0 month, 6 month, 12 month

Participants will be instructed to use a Withings wireless scale (stated accuracy to 0.1 kg) to weigh themselves. Participants will be instructed to step on the scale in the morning (before eating but after using the bathroom), wearing no shoes and minimal clothing, with the scale on a hard, flat, surface. Participants will be instructed to measure their weight for three consecutive days so that a participant's mean can be calculated at each time point in order to minimize the influence of daily fluctuations of weight. Data will be pulled from the Withings cloud to the study database via the Withings API. In order to maximize accuracy, we will remove errant weights (e.g., \>1 kg change in 1 day).

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Drexel university🇺🇸 Philadelphia, Pennsylvania, United States

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