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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adaptive SMARTer intervention (SMARTer) | Experimental | Smartphone application, diet and activity goals, online lessons, brief remote sessions with a Health Promotionist. Data from a wifi scale will be monitored. Individuals losing less than .5 lb per week will be stepped up to also be given meal replacement products. Will have physical measures taken at baseline, 3 months, 6 months, 9 months, and 12 months. |
|
| Diabetes Prevention Program (DPP) | Experimental | Fixed intervention using participant program manual, diet and activity logs, hour long remote sessions with a Health Promotionist. Will have physical measures taken at baseline, 3 months, 6 months, 9 months, and 12 months. |
|
| Self-Guided Treatment (Self-Guided) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive SMARTer intervention (SMARTer) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight - percent change | Participant percent change in weight (kg) from baseline to 6-months. | Baseline to 6-months |
| Weight - difference in kg | Participant change in weight (kg) from baseline to 6-months. | Baseline to 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12-months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to 12-months |
| Weight Maintenance - difference in kg |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keri A Gladhill, PhD | Contact | 850-645-5401 | keri.gladhill@med.fsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bonnie Spring, PhD | Florida State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida State University | Recruiting | Tallahassee | Florida | 32306 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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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 a Self-Guided control group. Assessors will be blinded to study condition, and intervention will be behavioral.
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| Diabetes Prevention Program (DPP) | Behavioral | 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. |
|
| Self-Guided Treatment (Self-Guided) | Behavioral | 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. |
|
Explore whether SMARTer stepped care treatment produces greater weight-loss (difference in kilograms) from baseline to 12-months and is noninferior to DPP
| Baseline to 12-months |
| 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. | Baseline to 6-months |
| 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. | Baseline to 6-months |
| Moderating effect of technology literacy on percent weight loss at 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. | Baseline to 6-months |
| Moderating effect of executive functioning on percent weight loss at 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. | Baseline to 6-months |
| Moderating effect of emotional eating on percent weight loss at 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. | Baseline to 6-months |
| Mediating effect of change in negative affect on percent weight loss at 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. | Baseline to 6-months |
| Mediating effect of change in craving on percent weight loss at 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. | Baseline to 6-months |
| Mediating effect of change in reward-based eating on percent weight loss at 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. | Baseline to 6-months |
| Mediating effect of change in inhibitory control on percent weight loss at 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. | Baseline to 6-months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |