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The purpose of the study was to evaluate the impact of augmented care at the worksite through a lifestyle intervention for diabetes prevention among employees with prediabetes who were slower to respond to a standard diabetes prevention intervention.
Employees at the Ohio State University (OSU) with prediabetes participated in a standard lifestyle intervention (Group Lifestyle Balance) for diabetes prevention. Participants who did not achieve >2.5% weight loss at week 5 of the intervention were stratified to the augmented intervention (Group Lifestyle Balance Plus) at week 5. The impact of the augmented intervention compared to the standard intervention was determined at 4, 12 and 18 months from baseline to determine if implementing early enhanced training helped participants achieve and maintain weight loss similar to those who received the standard intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Lifestyle Balance (GLB) | Active Comparator | Standard lifestyle intervention to promote weight loss |
|
| Group Lifestyle Balance Plus (GLB+) | Experimental | Augmented lifestyle intervention for early slow responders |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group Lifestyle Balance (GLB) | Behavioral | The intervention included the following key features: group-based sessions led by a lifestyle coach; a structured, state-of-the-art, 16-session core-curriculum that emphasized behavioral self-management strategies for weight loss and physical activity; 8-months of extended care with bimonthly or monthly sessions; self-monitoring of diet and physical activity. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Weight Change | Change in weight as measured in light clothing and shoes removed | baseline and 4-months |
| Percent Weight Change | Change in weight as measured in light clothing and shoes removed | baseline and 12-months |
| Percent Weight Change | Change in weight as measured in light clothing and shoes removed | 12-months and 18-months |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Glucose | Fasting glucose from a fingerstick sample | baseline and 4-months |
| Fasting Glucose | Fasting glucose from a fingerstick sample |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carla Miller, Ph.D. | The Ohio State University (during study implementation) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37226352 | Derived | Miller CK, Nagaraja HN, Cheavens JS, Fujita K, Lazarus SA, Brunette DS. Sex Differences in Early Weight Loss Success During a Diabetes Prevention Intervention. Am J Health Behav. 2023 Apr 30;47(2):337-348. doi: 10.5993/AJHB.47.2.13. | |
| 36933057 | Derived | Miller CK, King D, Nagaraja HN, Fujita K, Cheavens J, Focht BC. Impact of an augmented intervention on self-regulatory, dietary and physical activity outcomes in a diabetes prevention trial among adults with prediabetes. J Behav Med. 2023 Oct;46(5):770-780. doi: 10.1007/s10865-023-00406-w. Epub 2023 Mar 18. |
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De-identified data will be released to other researchers using a data-sharing agreement that specifies that the data will be used only for research purposes and only by the specified individuals to whom the data are released. Documentation of Institutional Review Board approval for the proposed use must be provided in advance to the PI. The data must be either destroyed or returned to the PI after all analyses are completed.
The data will be available following all analyses and publication of primary and secondary study results. The data will be available upon request.
To be developed
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Participants completed 4 weeks of the standard Group Lifestyle Balance (GLB) intervention. Those who achieved >2.5% weight loss at week 5 remained in GLB at week 5. Those who achieved <2.5% weight loss at week 5 were stratified to the GLB Plus (GLB+) intervention at week 5. Participants were paired based on percent weight change at month 5. Each member in the pair was randomized to group at month 5 for the study duration. Thus, group sample sizes are different at month 5 compared to month 4.
Employees from a Midwestern university with overweight or obesity and prediabetes were recruited from 2018-2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group Lifestyle Balance (GLB) | Standard lifestyle intervention |
| FG001 | Group Lifestyle Balance Plus (GLB+) | Augmented lifestyle intervention for slow responders |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Excludes people who withdrew from the study following stratification to treatment group
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| ID | Title | Description |
|---|---|---|
| BG000 | Group Lifestyle Balance (GLB) | Standard lifestyle intervention |
| BG001 | Group Lifestyle Balance Plus (GLB+) | Augmented lifestyle intervention for slow responders |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Weight Change | Change in weight as measured in light clothing and shoes removed | Posted | Least Squares Mean | Standard Error | percent change | baseline and 4-months |
|
|
18 months
Adverse events were collected at every participant contact using a standardized form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group Lifestyle Balance (GLB) | Standard lifestyle intervention | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hamstring tear | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Four participant cohorts did not complete the 18-month visit due to pandemic-related restrictions during the SARS-CoV-2 pandemic. Thus, the 18-month outcomes include a smaller sample and should be interpreted with caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carla Miller (current affiliation) | Indiana University | 812-855-1608 | ckm1@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2018 | Feb 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D006943 | Hyperglycemia |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The proposed translational study applied an innovative experimental approach, an adaptive design, to optimize treatment for weight loss and weight loss maintenance in individuals with prediabetes. All participants initiated a standard lifestyle intervention to promote weight loss. Those who did not achieve >2.5% weight loss during the first month of the intervention were stratified to augmented care to enhance weight loss during the intensive intervention phase. Following the intensive phase, participants were randomly assigned to either the standard intervention or the enhanced intervention for the maintenance study phase. By randomly assigning participants to either the standard maintenance phase of the intervention or the innovative maintenance phase of the intervention following the initial core phase, the impact of extended training in self-regulation for weight loss maintenance was evaluated.
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| Group Lifestyle Balance Plus (GLB+) | Behavioral | The GLB+ intervention arm included participants who did not achieve the targeted percent weight loss by week 5 and incorporated enhanced training in values clarification, mindful decision making, planning, and problem solving. GLB+ included the same number of group-based sessions as GLB. |
|
| baseline and 12-months |
| Fasting Glucose | Fasting glucose from a fingerstick sample | 12-months and 18-months |
| 36041053 | Derived | Miller CK, Nagaraja HN, Cheavens J, Fujita K, Lazarus S. Impact of a Novel Diabetes Prevention Intervention for Early Slow Weight Loss Responders Among Adults With Prediabetes: An Adaptive Trial. Diabetes Care. 2022 Oct 1;45(10):2452-2455. doi: 10.2337/dc22-0824. |
| Visit not completed due to pandemic |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body weight | Least Squares Mean | Standard Deviation | kg |
|
| Fasting glucose | Least Squares Mean | Standard Deviation | mg/dL |
|
| Participants |
|
|
|
| Primary | Percent Weight Change | Change in weight as measured in light clothing and shoes removed | Compares the change for the GLB/GLB intervention sequence to the GLB+/GLB+ intervention sequence (the primary comparison of interest at 12-months) | Posted | Least Squares Mean | Standard Error | percent change | baseline and 12-months |
|
|
|
|
| Primary | Percent Weight Change | Change in weight as measured in light clothing and shoes removed | Compares the GLB/GLB intervention sequence to the GLB+/GLB+ intervention sequence (the primary comparison of interest at 18-months for weight loss maintenance) | Posted | Least Squares Mean | Standard Error | percent change | 12-months and 18-months |
|
|
|
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| Secondary | Fasting Glucose | Fasting glucose from a fingerstick sample | Posted | Least Squares Mean | Standard Error | mg/dL | baseline and 4-months |
|
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|
|
| Secondary | Fasting Glucose | Fasting glucose from a fingerstick sample | Compares the GLB/GLB intervention sequence to GLB+/GLB+ intervention sequence (the primary comparison of interest at 12-months) | Posted | Least Squares Mean | Standard Error | mg/dL | baseline and 12-months |
|
|
|
|
| Secondary | Fasting Glucose | Fasting glucose from a fingerstick sample | Compares the GLB/GLB intervention sequence to the GLB+/GLB+ intervention sequence (the primary comparison of interest at 18-months) | Posted | Least Squares Mean | Standard Error | mg/dL | 12-months and 18-months |
|
|
|
|
| 86 |
| 2 |
| 86 |
| 4 |
| 86 |
| EG001 | Group Lifestyle Balance Plus (GLB+) | Augmented lifestyle intervention for slow responders | 1 | 122 | 3 | 122 | 13 | 122 |
| Hip replacement | Surgical and medical procedures | Systematic Assessment |
|
| Arrythmia | Congenital, familial and genetic disorders | Systematic Assessment |
|
| Colon abscess | Gastrointestinal disorders | Systematic Assessment |
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| Hand surgery | Surgical and medical procedures | Systematic Assessment |
|
| Knee or hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |