SMARTer Weight Loss Management
ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFlorida State University
About this trial
The SMARTer trial will be a three-arm, randomized controlled non-inferiority trial that compares the optimized, adaptive SMARTer intervention, fixed DPP, and Self-Guided (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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Over 18 years old
BMI of ≥25, weight <396 lbs
Must own a Smartphone, and be willing to install the SMARTer app
Not enrolled in a formal weight loss program
Disqualifiers
Cerebrovascular accident or myocardial infarction within six months of enrollment
Diabetes treated with insulin
Pregnancy, lactation or intended pregnancy
Active suicidal ideation
Trial design
Design model
Parallel
Treatments tested in this trial
Adaptive SMARTer intervention (SMARTer)
BehavioralParticipants will receive calorie, fat, and physical activity goals, a Smartphone application for self-monitoring their diet, activity and weight, online educational readings, and brief bi-weekly remote health sessions with a Health Promotionist. They will also be loaned a Fitbit tracking device and a wireless Bluetooth scale for 12 months.
Diabetes Prevention Program (DPP)
BehavioralIn accordance with the Center for Disease Control curriculum, participants will receive a participant log for tracking physical activity, food intake, and weight, a paper participant guide with worksheets, logs, and psycho-educational materials, and 16 hour long remote sessions with a Health Promotionist.
Self-Guided Treatment (Self-Guided)
BehavioralProvides paper and internet resources tailored to geographic area, educating on leading a healthier lifestyle, including information on wellness and physical activity. Will have physical measures taken at baseline, 3 months, 6 months, 9 months, and 12 months.
Treatment groups
492 Participants
are divided into 3 treatment groupsGroup A: Adaptive SMARTer intervention (SMARTer)Experimental treatment 1 intervention
Group B: Diabetes Prevention Program (DPP)Experimental treatment 1 intervention
Group C: Self-Guided Treatment (Self-Guided)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Weight - percent change
Participant percent change in weight (kg) from baseline to 6-months.
Time frame
Baseline to 6-months2
Weight - difference in kg
Participant change in weight (kg) from baseline to 6-months.
Time frame
Baseline to 6-monthsSecondary outcomes
1
Cost
Costs of SMARTer versus DPP versus Control implementation. We will utilize a micro-costing approach to capture all costs associated with the implementation of the treatment arms.
Time frame
12-monthsOther outcomes
1
Weight Maintenance - percent change
Explore whether SMARTer stepped care treatment produces greater weight-loss (percent change) from baseline to 12-months and is noninferior to DPP
Time frame
Baseline to 12-months2
Weight Maintenance - difference in kg
Explore whether SMARTer stepped care treatment produces greater weight-loss (difference in kilograms) from baseline to 12-months and is noninferior to DPP
Time frame
Baseline to 12-months3
Moderating effect of food insecurity on percent weight loss at 6 months
Interaction effect between intervention group (SMARTer vs DPP vs Control) and food insecurity on percent weight loss at 6 months, estimated using a linear regression interaction term (β coefficient). Food insecurity will be assessed using a validated 2-item screener based on the U.S. Household Food Security Survey Module, consisting of two items: (1) worry that food would run out and (2) food not lasting. Response options are "Often true," "Sometimes true," and "Never true." Responses will be scored dichotomously (food insecure vs food secure), with food insecurity defined as ≥1 response of "Often true" or "Sometimes true." Percent weight loss will be calculated as percent change in body weight from baseline to 6 months.
Time frame
Baseline to 6-months4
Moderating effect of neighborhood deprivation on percent weight loss at 6 months
An interaction effect between intervention group (SMARTer vs DPP vs Control) and neighborhood deprivation on percent weight loss at 6 months will be estimated using a linear regression model with an interaction term (β coefficient). Neighborhood deprivation will be assessed using a Neighborhood Deprivation Index (NDI) derived from U.S. Census tract-level socioeconomic indicators obtained from the American Community Survey, following methods developed by Diez Roux and colleagues. The NDI will be expressed as a standardized continuous score (z-score), with higher values indicating greater neighborhood deprivation. Percent weight loss will be calculated as percent change in body weight from baseline to 6 months.
Time frame
Baseline to 6-monthsSponsors and contacts
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Source ClinicalTrials.gov