Supporting Decisions on Lifestyle Change

NCT06206954 | Enrolling By Invitation

• 2 other identifiers: IRB202300516R01DK134409
• Study Type: interventional
• Target: 864
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Keywords

initiation; recruitment; engagement; behavioral intervention

Outcome Measures

Primary Outcomes (1)

• Proportion initiating treatment

  Attend at least one intervention session of comprehensive behavioral weight loss intervention. Documented by interventionist/program.

  Within 2 months of PCP appointment date

Secondary Outcomes (4)

• Number of treatment sessions attended

  6 months

• Proportion discussing weight-related topic with PCP

  at completion of PCP visit (occuring up to 4 weeks after enrollment)

• Proportion achieving 5% weight loss

  6 months

• Percent weight loss

  6 months

Study Arms (2)

MyHealthPath Tool

EXPERIMENTAL

Receive MyHealthPath Tool intervention.

Behavioral: MyHealthPath Tool

MyHealthPath Guide

ACTIVE COMPARATOR

Receive MyHealthPath Guide intervention

Behavioral: MyHealthPath Guide

Interventions

MyHealthPath Tool BEHAVIORAL

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

MyHealthPath Tool

MyHealthPath Guide BEHAVIORAL

Informational material to help patients learn about weight treatment options

MyHealthPath Guide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Megan A McVay, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel cluster randomized

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 16, 2024
• Study Start: January 24, 2024
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available within one year of study completion and remain available indefinitely.
• Access Criteria: Access will be granted to researchers for any scientific purpose, including verifying/replicating analyses or conducting additional analyses, or

Locations

US (1)