Supporting Decisions on Lifestyle Change

NCT ID: NCT06206954

Last Updated: 2025-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

864 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-24

Study Completion Date

2028-07-30

Brief Summary

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This study will test the effects of a brief, individually tailored intervention aiming to increase initiation of comprehensive behavioral weight loss treatment on weight.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel cluster randomized
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Investigators (with exception of statistician) will be masked to study condition. Outcome assessors and all staff engaging directly with participants will be masked to study condition, except those staff who are sending intervention content.

Study Groups

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MyHealthPath Tool

Receive MyHealthPath Tool intervention.

Group Type EXPERIMENTAL

MyHealthPath Tool

Intervention Type BEHAVIORAL

Tailored, brief online tool to help patients learn about weight treatment options

MyHealthPath Guide

Receive MyHealthPath Guide intervention

Group Type ACTIVE_COMPARATOR

MyHealthPath Guide

Intervention Type BEHAVIORAL

Informational material to help patients learn about weight treatment options

Interventions

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MyHealthPath Tool

Tailored, brief online tool to help patients learn about weight treatment options

Intervention Type BEHAVIORAL

MyHealthPath Guide

Informational material to help patients learn about weight treatment options

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 18 or older
* Body Mass Index (BMI) ≥ 30 kg/m2 based on self-report body weight and height, or BMI ≥ 27-29.9 kg/m2 with a weight related comorbidity of hypertension, type 2 diabetes, pre-diabetes, dyslipidemia, or obstructive sleep apnea, gastroesophageal reflux disease, or coronary artery disease.
* Self-report weight ≤ 375 lbs (the maximum weight that BodyTrace scales can accurately detect is 397 lbs, thus 375 lbs provides a buffer to allow detection of at least 20 lbs weight gain).
* Has a desire to weigh less
* Has valid email address in Electronic Health Record
* Has an appointment scheduled with enrolled PCP about 21-28 days after electronic data pull
* Speaks and reads English
* Has either WiFi internet access at home or a phone or tablet with a data plan.

Exclusion Criteria

* Currently enrolled in evidence-based comprehensive weight loss treatment
* Pregnant or planning to become pregnant in the next 6 months
* Currently breastfeeding (or pumping breastmilk) more than 3 times per day.
* Currently undergoing treatment for cancer
* Had cardiovascular event in the past 60 days
* Severe depression symptoms on PHQ-8 (total score ≥20)
* Inpatient psychiatric treatment in the past 6 months
* Eating disorder in past 5 years
* Congestive heart failure resulting in recent (past 6 months) hospitalization or contributing to difficulty breathing or difficulty doing daily activities.
* Dementia diagnosis
* Bariatric surgery in the past year or currently undergoing evaluation for bariatric surgery
* Currently taking doctor-prescribed medication for weight loss
* Inability to stand on body weight scale independently
* Impaired hearing
* Unable to read content on websites without assistance
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Megan A McVay, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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R01DK134409

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB202300516

Identifier Type: -

Identifier Source: org_study_id

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