Florida State University
Tallahassee, Florida, 32306, United States
Location status: Recruiting
Location contact
Bonnie Spring, PhD
CONTACT
Bonnie Spring, PhD
PRINCIPAL_INVESTIGATOR
Keri A Gladhill, PhD
CONTACT
NCT Number: NCT05861973
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Tallahassee, Florida, 32306, United States
Location status: Recruiting
Bonnie Spring, PhD
CONTACT
Bonnie Spring, PhD
PRINCIPAL_INVESTIGATOR
Keri A Gladhill, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants 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.
In 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.
Provides 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.
Time frame: Baseline to 6-months
Participant percent change in weight (kg) from baseline to 6-months.
Time frame: Baseline to 6-months
Participant change in weight (kg) from baseline to 6-months.
Time frame: 12-months
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: Baseline to 12-months
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-months
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 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-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-months
Interaction effect between intervention group (SMARTer vs DPP vs Control) and technology literacy on percent weight loss at 6 months, estimated using a linear regression interaction term (β coefficient). Technology literacy will be assessed using the eHealth Literacy Scale (eHEALS; 8-item measure) total score (range: 8-40), with higher scores indicating greater perceived eHealth literacy. Percent weight loss will be calculated as percent change in body weight from baseline to 6 months.
Time frame: Baseline to 6-months
Interaction effect between intervention group (SMARTer vs DPP vs Control) and executive functioning on percent weight loss at 6 months, estimated using a linear regression interaction term (β coefficient). Executive functioning will be assessed using the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Global Executive Composite (GEC) T-score (standardized score; mean = 50, SD = 10), with higher scores indicating greater executive dysfunction. Percent weight loss will be calculated as percent change in body weight from baseline to 6 months.
Time frame: Baseline to 6-months
Interaction effect between intervention group (SMARTer vs DPP vs Control) and emotional eating on percent weight loss at 6 months, estimated using a linear regression interaction term (β coefficient). Emotional eating will be assessed using the Palatable Eating Motives Scale (PEMS) Coping subscale mean score (range: 1-5), with higher scores indicating greater eating in response to negative emotions. Percent weight loss will be calculated as percent change in body weight from baseline to 6 months.
Time frame: Baseline to 6-months
Indirect effect of intervention group (SMARTer vs DPP vs Control) on percent weight loss at 6 months through change in negative affect, estimated using mediation analysis (indirect effect coefficient). Negative affect will be assessed using the Positive and Negative Affect Schedule (PANAS) Negative Affect subscale score (range: 10-50), with higher scores indicating greater negative affect. Change will be calculated from baseline to follow-up assessments.
Time frame: Baseline to 6-months
Indirect effect of intervention group (SMARTer vs DPP vs Control) on percent weight loss at 6 months through change in craving, estimated using mediation analysis (indirect effect coefficient). Craving will be assessed using a 1-item visual analogue scale (VAS) (range: 0-100), with higher scores indicating greater craving. Change will be calculated from baseline to follow-up assessments.
Time frame: Baseline to 6-months
Indirect effect of intervention group (SMARTer vs DPP vs Control) on percent weight loss at 6 months through change in reward-based eating, estimated using mediation analysis (indirect effect coefficient). Reward-based eating will be assessed using the Reward-Based Eating Drive (RED) scale total score (continuous; higher scores indicate greater reward-driven eating). Change will be calculated from baseline to 6 months.
Time frame: Baseline to 6-months
Indirect effect of intervention group (SMARTer vs DPP vs Control) on percent weight loss at 6 months through change in inhibitory control, estimated using mediation analysis (indirect effect coefficient). Inhibitory control will be assessed using the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Inhibit subscale T-score (mean = 50, SD = 10), with higher scores indicating poorer inhibitory control. Change will be calculated from baseline to 6 months.
Contact information is provided by the study sponsor or research team.
Florida State University
Other
Acronym: SMARTer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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