Obesity
Conditions
Keywords
initiation, recruitment, engagement, behavioral intervention
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.
Interventions
BEHAVIORALMyHealthPath Tool
Tailored, brief online tool to help patients learn about weight treatment options
BEHAVIORALMyHealthPath Guide
Informational material to help patients learn about weight treatment options
Sponsors
University of Florida
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Parallel cluster randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment sessions attended | 6 months | Total number of attended intervention session of comprehensive behavioral weight loss intervention. Documented by interventionist/program. |
| 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. |
| Proportion achieving 5% weight loss | 6 months | Proportion of participants losing 5% of their baseline weight between baseline and 6 months |
| Percent weight loss | 6 months | Percent weight loss from baseline to 6 months |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMegan A McVay, PhD
University of Florida
Outcome results
None listed