Clinical trial NCT05861973: SMARTer Weight Loss Management
Official title: SMARTer Weight Loss Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 492
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized control trial with 3 parallel intervention arms. One arm will be the SMARTer active treatment group, one the active DPP treatment group, and the other an assessments-only control group. Assessors will be blinded to study condition, and intervention will be behavioral.
Primary purpose: TREATMENT

Brief summary: The SMARTer trial will be a three-arm, randomized controlled non-inferiority trial that compares the optimized, adaptive SMARTer intervention, fixed DPP, and usual care assessment-only (Control). The trial will address whether a scalable, stepped-care intervention can stand up to gold-standard DPP by achieving comparable weight loss at a lower cost. Alongside evaluation of clinical non-inferiority, a comprehensive economic evaluation will inform relative affordability. Cost information is important to inform treatment policy and change standard of care, but is sorely lacking for behavioral interventions. The SMARTer intervention reduces costs by initially offering minimal intervention to all and stepping up to offer more costly treatment components only to non-responders who fail to attain the target weight loss. A rigorous economic evaluation planned and designed alongside the SMARTer trial will provide an accurate, robust head-to-head comparison of costs, cost-effectiveness, and projected lifetime health care costs between the three arms.

Detailed description: The proposed study seeks to test the hypothesis that SMARTer is non-inferior to DPP in its effect on 6-month weight loss. During the 24-week active intervention phase, participants will be randomized to one of three first-line treatments: 1) the adaptive SMARTer intervention, 2) fixed DPP, or 3) usual care assessment-only (control). Participants will be assessed at 3-month, 6-month, 9-month, and 12-month timepoints to evaluate overall weight loss, and to explore whether SMARTer is cost-effective compared to DPP or standard care.

Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* BMI of ≥25, weight \<396 lbs
* Must own a Smartphone, and be willing to install the SMARTer app
* Participants must also plan to reside in the Chicagoland area for the duration of their participation (i.e., 12 months)
* Not enrolled in a formal weight loss program

Exclusion Criteria:

* Cerebrovascular accident or myocardial infarction within six months of enrollment
* Diabetes treated with insulin
* Pregnancy, lactation or intended pregnancy
* Active suicidal ideation
* Anorexia or bulimia
* Requiring an assistive device for mobility
* Taking weight loss medications, such as GLP-1 agonists

Primary outcomes:
measure: Weight
timeFrame: Baseline to 6-Months
Secondary outcomes:
measure: Cost
timeFrame: 12 Months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Bonnie Spring, PhD
role: PRINCIPAL_INVESTIGATOR
References: