Supporting Decisions on Lifestyle Change

Not Applicable

• Conditions: Obesity
• Interventions: Behavioral: MyHealthPath Guide; Behavioral: MyHealthPath Tool

• Registration Number: NCT06206954
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-12
• Study First Posted: 2024-01-16
• Study Start: 2024-01-24
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16
• Primary Completion: 2027-03-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 864

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MyHealthPath Guide	MyHealthPath Guide	Receive MyHealthPath Guide intervention
MyHealthPath Tool	MyHealthPath Tool	Receive MyHealthPath Tool intervention.

Primary Outcome Measures

Name	Time	Method
Proportion initiating treatment	Within 2 months of PCP appointment date	Attend at least one intervention session of comprehensive behavioral weight loss intervention. Documented by interventionist/program.

Secondary Outcome Measures

Name	Time	Method
Proportion achieving 5% weight loss	6 months	Proportion of participants losing 5% of their baseline weight between baseline and 6 months
Number of treatment sessions attended	6 months	Total number of attended intervention session of comprehensive behavioral weight loss intervention. Documented by interventionist/program.
Percent weight loss	6 months	Percent weight loss from baseline to 6 months
Proportion discussing weight-related topic with PCP	at completion of PCP visit (occuring up to 4 weeks after enrollment)	Per patient self-report, discussed weight, diet, or physical activity with PCP at index PCP visit.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States