Supporting Decisions on Lifestyle Change

Obesity Clinical Trial

Official title:

Increasing Initiation of Evidence-based Weight Loss Treatment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06206954
• Other study ID #: IRB202300516
• Secondary ID: R01DK134409
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 24, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 864
• Est. completion date: June 30, 2027
• Est. primary completion date: March 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• MyHealthPath Tool
Tailored, brief online tool to help patients learn about weight treatment options
• MyHealthPath Guide
Informational material to help patients learn about weight treatment options

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

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