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| ID | Type | Description | Link |
|---|---|---|---|
| OT2HL158287 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Pennington Biomedical Research Center | OTHER |
| University of Pennsylvania | OTHER |
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The primary objective of the STRIVE study is to compare two implementation strategies for Diabetes Prevention Program delivery: an in-person health coach strategy (standard 24 in-person sessions at WIC clinics) vs. a multifaceted technology-assisted health coach implementation strategy (12 in-person sessions at WIC clinics supplemented by technology support) on implementation and health-related outcomes in postpartum women.
The overall objective of this project is to study the implementation, effectiveness, and sustainability of implementing the Diabetes Prevention Program (DPP) in postpartum women who receive services from WIC. In this effectiveness-implementation type III cluster-randomized trial, we will compare two implementation strategies for DPP delivery: an in-person health coach-led implementation strategy (standard 24 in-person sessions) vs. a multifaceted technology-assisted health coach implementation strategy (12 in-person sessions supplemented by technology tools).
Nineteen clinics will be randomized to the multifaceted technology-assisted health coach strategy and 19 to the in-person health coach-led strategy. A total of 722 postpartum participants (19 per clinic) will be recruited into the study and followed for 12 months for implementation and effectiveness outcomes. A post-intervention study visit will take place 6 months after the end of the 12-month intervention to evaluate the sustainability of the implementation strategies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-person health coach strategy | Active Comparator | Delivery of 24 health coaching sessions in-person by health coaches over 1 year. Standard delivery of 24-sessions of the Group Lifestyle Balance (GLB) behavioral intervention in WIC clinics. The GLB was adapted from the original Lifestyle Balance behavioral intervention used in the original Diabetes Prevention Program trial for use in community translation and group settings. It focuses on improving diet and physical activity and promoting moderate weight loss through health coaching on behavioral change, including self-monitoring of food intake, physical activity, and weight. |
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| Multifaceted technology-assisted health coach implementation strategy | Active Comparator | Delivery of 12 health coaching GLB sessions in-person by health coaches over one year; supplemental technology support, including tools for self-monitoring, health coach monitoring, asynchronous delivery of intervention materials, and asynchronous coach and group connection. The GLB was adapted from the original Lifestyle Balance behavioral intervention used in the original Diabetes Prevention Program trial for use in community translation and group settings. It focuses on improving diet and physical activity and promoting moderate weight loss through health coaching on behavioral change, including self-monitoring of food intake, physical activity, and weight. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-person health coach delivery of the GLB | Behavioral | Delivery of 24 health coaching sessions in-person by health coaches over 1 year. Standard delivery of 24-sessions of the Group Lifestyle Balance (GLB) behavioral intervention in WIC clinics. The GLB was adapted from the original Lifestyle Balance behavioral intervention used in the original Diabetes Prevention Program trial for use in community translation and group settings. It focuses on improving diet and physical activity and promoting moderate weight loss through health coaching on behavioral change, including self-monitoring of food intake, physical activity, and weight. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in uptake (primary implementation outcome) | The primary implementation outcome will be the difference between study arms in a composite uptake score, as defined by a composite score consisting of the percent of sessions attended and the percentage of times in which participants record weight, activity, and diet compared to what is recommended by the intervention. | Measured from baseline to 12 months |
| Difference in mean 12-month weight reduction (primary health-related outcome) | The primary health-related outcome will be difference in mean weight reduction from baseline to 12 months between study arms | Measured at 3, 6, 9 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fidelity | Percentage of sessions held | 12 months |
| Acceptability | Acceptability scores for participants, DPP coordinators, DPP coaches, WIC clinic management. Measured by survey; higher score means better outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Sustainability (DPP coordinators): comparison of perceived sustainability of the two implementation strategies among WIC staff | Assessed by surveys and interviews | 18 months |
| Sustainability (Participants): comparison of the proportion of participants maintaining DPP goals at six months after their participation in the DPP has ended |
Inclusion Criteria for Clinics:
Inclusion Criteria for Participants:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tara Dobson, BA | Contact | 504.988.9922 | tdobson@tulane.edu | |
| Kirsten Dorans, ScD | Contact | 504.988.0883 | kdorans@tulane.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tulane University School of Public Health and Tropical Medicine | Recruiting | New Orleans | Louisiana | 70112 | United States |
Our study data sharing plan will comply with all NIH policies for data sharing. Data sharing will be implemented in a timely manner. Study data, including data from baseline and follow-up visits, will be prepared sharing. Data will be prepared by the study data manager/biostatistician. These data will be free of identifiers that allow identification of individual research participants either directly or through "deductive disclosure." We are very open to sharing data enthusiastically with the general scientific community, since we also believe in the added value of other investigators working on these data.
Data sets will be prepared for sharing no later than 3 years after the end of the final patient follow-up visit or 2 years after the main paper of the trial has been published, whichever comes first.
We will offer opportunities for outside investigators to collaborate with us using complete study data.
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Cluster-randomization of 38 Women, Infants, and Children (WIC) clinics
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Due to the nature of the cluster design and intervention program, the study participants, health coaches, DPP Coordinators, WIC clinic staff, and research staff who collect clinical outcome data will not be blinded.
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| Technology-assisted health coach delivery of the GLB | Behavioral | Delivery of 12 health coaching GLB sessions in-person by health coaches over one year; supplemental technology support, including tools for self-monitoring, health coach monitoring, asynchronous delivery of intervention materials, and asynchronous coach and group connection. The GLB was adapted from the original Lifestyle Balance behavioral intervention used in the original Diabetes Prevention Program trial for use in community translation and group settings. It focuses on improving diet and physical activity and promoting moderate weight loss through health coaching on behavioral change, including self-monitoring of food intake, physical activity, and weight. |
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| Measured at baseline, 6, and 12 months |
| Appropriateness | Appropriateness scores for participants, DPP coordinators, DPP coaches, WIC clinic management. Measured by survey; higher score means better outcome. | baseline |
| Feasibility (suitability) | Feasibility scores for participants, DPP coordinators, DPP coaches, and WIC clinic management. Measured by survey; higher score means better outcome. | Baseline |
| Adoption (WIC clinics) | Percentage of invited WIC clinics adopting the DPP program. Measured by study administrative data. | Baseline |
| Adoption (WIC nutritionists) | Percentage of invited WIC nutritionists being trained. Measured by study administrative data. | Baseline |
| Adoption (WIC health educators) | Percentage of invited WIC health educators being trained. Measured by study administrative data. | Baseline |
| Penetrance (participants) | Percentage of enrolled participants receiving assigned intervention. Measured by study administrative data. | 12 months |
| Penetrance (WIC DPP coordinators) | Percentage of percentage of trained WIC DPP coordinators supporting health coaches. Measured by study administrative data. | 12 months |
| Penetrance (WIC health coaches) | Percentage of percentage of trained WIC DPP health coaches delivering the intervention. Measured by study administrative data. | 12 months |
| Percentage of participants who were either eligible, screened, or contacted who were enrolled. | Reach | Baseline |
| Cost-effectiveness | Incremental direct costs (intervention) per additional percentage of individuals reaching weight loss goal at 12 months | 12 months |
| Difference in mean 12-month change in percent weight reduction | Difference in mean percent weight reduction from baseline to 12 months between study arms | Measured from baseline to 12 months |
| Difference in mean 12-month change in physical activity | Difference in mean change in physical activity from baseline to 12 months between study arms, as assessed by metabolic equivalent (MET)-h/week (measured by validated questionnaire) | Measured from baseline to 12 months |
| Difference in mean 12-month change in healthy eating index | Difference in mean change in healthy eating index from baseline to 12 months between study arms, as assessed by 24-hour dietary recalls (range 0 to 100; higher scores mean healthier eating pattern) | Measured from baseline to 12 months |
| Difference in mean 12-month change in waist circumference | Difference in mean change in waist circumference from baseline to 12 months between study arms | Measured from baseline to 12 months |
| Difference in mean 12-month change in hemoglobin A1c | Difference in mean change in hemoglobin A1c from baseline to 12 months between study arms | Measured from baseline to 12 months |
| Difference in mean 12-month change in systolic blood pressure | Difference in mean change in systolic blood pressure from baseline to 12 months between study arms | Measured from baseline to 12 months |
| Difference in mean 12-month change in diastolic blood pressure | Difference in mean change in diastolic blood pressure from baseline to 12 months between study arms | Measured from baseline to 12 months |
| Difference in mean 12-month change in health-related quality of life (HRQoL) | Difference in mean change in health-related quality of life (HRQoL) from baseline to 12 months between study arms (assessed by short form (SF)-12, validated survey) | Measured from baseline to 12 months |
| Difference in proportion of participants meeting intervention goals at 12 months | Assessed by validated questionnaires, 24-hour dietary recalls, and weight measurements | Measured from baseline to 12 months |
Assessed by validated questionnaires, 24-hour dietary recalls, and weight measurements |
| 18 months |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D016640 | Diabetes, Gestational |
| D011236 | Prediabetic State |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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