Clinical trial NCT06206954: Supporting Decisions on Lifestyle Change
Official title: Increasing Initiation of Evidence-based Weight Loss Treatment
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Obesity
Keywords: initiation
recruitment
engagement
behavioral intervention
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-01-16
Enrollment: 864
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel cluster randomized
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion initiating treatment
timeFrame: Within 2 months of PCP appointment date
Secondary outcomes:
measure: Number of treatment sessions attended
timeFrame: 6 months
measure: Proportion discussing weight-related topic with PCP
timeFrame: at completion of PCP visit (occuring up to 4 weeks after enrollment)
measure: Proportion achieving 5% weight loss
timeFrame: 6 months
measure: Percent weight loss
timeFrame: 6 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Megan A McVay, PhD
role: PRINCIPAL_INVESTIGATOR
References: