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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DK125033-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| University of Cincinnati | OTHER |
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The purpose of this study is to test the acceptability and effectiveness of an individualized eating strategy as part of diabetes self-management to improve glycemic levels among youth with type 1 diabetes (T1D) and suboptimal glycemic management. Investigators will assess participant acceptability of and adherence to a 6-month individualized eating strategy ("MyPlan") characterized by approximate day-to-day consistency in the frequency and timing of meals and snacks and distribution of carbohydrate throughout the day. Within-individual change in glycemic levels between baseline and 6-months of the study will also be compared. The goal of the study is to inform the design of a future randomized clinical trial to test the addition of the MyPlan eating strategy to ongoing diabetes clinical care among youth with T1D.
This is a pilot, single-arm clinical trial to assess whether "MyPlan" is an acceptable and effective dietary strategy to be included in future fully powered trials aimed at optimizing diabetes outcomes in youth with T1D. Youth and guardian dyads will be enrolled for a total of 6 months, during which time dyads will be counseled to follow an individualized eating pattern ("MyPlan") defined by five eating behavior goals: 3-4 meals per day and 1-2 optional snacks; eating occasions no less than 2 hours or greater than 4 hours apart; target carbohydrate ranges for each eating occasion; no post-dinner snacking; eating occasion within 1-2 hours of waking. The plan, including the eating behavior goals, will be tailored to youth and family routines and preferences. Registered dieticians will support participant adherence to the plan via telehealth counseling sessions on a weekly basis for the first 2 months followed by bi-weekly sessions for 4 months. Investigators will assess a) acceptability of the eating pattern and counseling strategy according to youth and guardians; b) youth adherence to the five eating behavior targets; c) change in youth glycemic levels between baseline and 6-months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "MyPlan" - Individualized Planned Eating Pattern | Experimental | All youth enrolled in the study will receive the 6-month MyPlan behavioral intervention. Youth and their guardian will be paired with a dietitian to individualize the eating pattern and receive support in setting and refining action plans focused on adhering to the five eating behavior goals that define the eating pattern. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "MyPlan" - Individualized Planned Eating Pattern | Behavioral | Sessions involve a structured behavior change counseling module derived from FLEX (NCT01286350), DASH-4-Teens (NCT00585832), and a Social Cognitive Theory and Transtheoretical Model informed conceptual framework, which uses education, motivation and self-efficacy enhancement, goal setting, and problem-solving skills training to initiate and sustain eating pattern adherence. Sessions support incremental progress towards meeting all five eating behavior goals by helping youth develop action plans, troubleshoot barriers to adherence, and refine action plans to improve adherence. Youth log in MyFitnessPal at least three days per week. Logs are used to assess and troubleshoot adherence, support youth in developing and refining action plans, and reward youth with points. Incentives are allocated using a point scheme designed to promote logging and goal achievement. Formal adjustment of the eating pattern is based on adherence according to logs and youth/guardian acceptability. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Time in Range (Baseline) | Percentage of time spent in the glycemic range of 70-180 mg/dL between Baseline week 0-2 week of blinded continuous glucose monitor (CGM) wear time. | Baseline (Week 0-2) |
| Percent Time in Range (Week 22-24) | Percentage of time spent in the glycemic range of 70-180 mg/dL during Week 22-24 of blinded continuous glucose monitor (CGM) wear time. | Week 22-24 |
| Adherence to Each Eating Behavior Goal | Percentage of participants who adhered to each eating behavior goal assessed through two unannounced 24-hour dietary recalls (1 weekday and 1 weekend day) collected during Week 22-24: Goal 1. 3-4 meals and 0-2 snacks; Goal 2. Spacing of meals/snacks >2 hours and <4 hours apart; Goal 3. Carbohydrate gram target ranges at meals (>15% daily carbohydrate) and snacks; Goal 4. No snacking after dinner; Goal 5. Meal/snack consumed ≤2 hours of waking; | Between Week 22 and Week 24 |
| Adherence to 0-5 Eating Behavior Goals | Percentage of participants who adhered to 0-5 eating behavior goals assessed through two unannounced 24-hour dietary recalls (1 weekday and 1 weekend day) collected during Week 22 - 24. Goal 1. 3-4 meals and 0-2 snacks; Goal 2. Spacing of meals/snacks >2 hours and <4 hours apart Goal 3. Carbohydrate gram target ranges at meals (>15% daily carbohydrate) and snacks Goal 4. No snacking after dinner Goal 5. Meal/snack consumed ≤2 hours of waking | Between Week 22 and Week 24 |
| Mean Adherence to Overall Eating Behavior Pattern | Mean number of eating behavior goals (range: 0-5) adhered to by participants as assessed through two unannounced 24-hour dietary recalls (1 weekday and 1 weekend day) collected during Week 22 - 24: Goal 1. 3-4 meals and 0-2 snacks; Goal 2. Spacing of meals/snacks >2 hours and <4 hours apart; Goal 3. Carbohydrate gram target ranges at meals (>15% daily carbohydrate) and snacks; Goal 4. No snacking after dinner; Goal 5. Meal/snack consumed ≤2 hours of waking; |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c Percentage | Change in point-of-care hemoglobin A1c (HbA1c) percentage. | Baseline (Week 0) and Endline (Week 26) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth J Mayer-Davis, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Sarah Couch, PhD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States | ||
| University of Cincinnati |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8040759 | Background | Effect of intensive diabetes treatment on the development and progression of long-term complications in adolescents with insulin-dependent diabetes mellitus: Diabetes Control and Complications Trial. Diabetes Control and Complications Trial Research Group. J Pediatr. 1994 Aug;125(2):177-88. doi: 10.1016/s0022-3476(94)70190-3. | |
| 16371630 | Background | Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 Dec 22;353(25):2643-53. doi: 10.1056/NEJMoa052187. |
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Deidentified individual data that supports the results will be shared beginning 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill (UNC).
Beginning 36 months following publication. No end date.
The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.
Not provided
Fifty-two guardians and youth were enrolled as dyads. A total of 44 dyads were included in the analysis.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | "MyPlan" - Individualized Eating Pattern | All youth enrolled in the study will receive the 6-month MyPlan behavioral intervention. Youth will be paired with a dietitian to individualize the eating plan and receive support in setting and refining action plans focused on adhering to the five eating behavior goals that define the eating plan. "MyPlan" - Individualized Eating Pattern: Sessions involve a structured behavior change counseling module derived from FLEX (NCT01286350), DASH-4-Teens (NCT00585832), and a Social Cognitive Theory and Transtheoretical Model informed conceptual framework, which uses education, motivation and self-efficacy enhancement, goal setting, and problem-solving skills training to initiate and sustain eating plan adherence. Sessions support incremental progress towards meeting all five eating behavior goals by helping youth develop action plans, troubleshoot barriers to adherence, and refine action plans to improve adherence. Youth log in MyFitnessPal three days per week. Logs are used to assess and troubleshoot adherence, support youth in developing and refining action plans, and reward youth with points. Incentives are allocated using a point scheme designed to promote logging and goal achievement. Formal adjustment of eating plan at three months is based on weight status, adherence according to logs, and youth/guardian acceptability. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline data was only collected for youth.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | "MyPlan" - Individualized Eating Pattern | All youth enrolled in the study will receive the 6-month MyPlan behavioral intervention. Youth will be paired with a dietitian to individualize the eating plan and receive support in setting and refining action plans focused on adhering to the five eating behavior goals that define the eating plan. "MyPlan" - Individualized Eating Pattern: Sessions involve a structured behavior change counseling module derived from FLEX (NCT01286350), DASH-4-Teens (NCT00585832), and a Social Cognitive Theory and Transtheoretical Model informed conceptual framework, which uses education, motivation and self-efficacy enhancement, goal setting, and problem-solving skills training to initiate and sustain eating plan adherence. Sessions support incremental progress towards meeting all five eating behavior goals by helping youth develop action plans, troubleshoot barriers to adherence, and refine action plans to improve adherence. Youth log in MyFitnessPal three days per week. Logs are used to assess and troubleshoot adherence, support youth in developing and refining action plans, and reward youth with points. Incentives are allocated using a point scheme designed to promote logging and goal achievement. Formal adjustment of eating plan at three months is based on weight status, adherence according to logs, and youth/guardian acceptability. |
| 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 Time in Range (Baseline) | Percentage of time spent in the glycemic range of 70-180 mg/dL between Baseline week 0-2 week of blinded continuous glucose monitor (CGM) wear time. | Data from study-provided continuous glucose monitors was not available for 10 participants. | Posted | Mean | Standard Deviation | percentage of CGM wear time | Baseline (Week 0-2) |
|
From the time of signing informed consent through study completion, up to approximately 26 weeks.
Adverse events were not collected for Guardians.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | "MyPlan" - Individualized Eating Pattern | All youth enrolled in the study will receive the 6-month MyPlan behavioral intervention. Youth will be paired with a dietitian to individualize the eating plan and receive support in setting and refining action plans focused on adhering to the five eating behavior goals that define the eating plan. "MyPlan" - Individualized Eating Pattern: Sessions involve a structured behavior change counseling module derived from FLEX (NCT01286350), DASH-4-Teens (NCT00585832), and a Social Cognitive Theory and Transtheoretical Model informed conceptual framework, which uses education, motivation and self-efficacy enhancement, goal setting, and problem-solving skills training to initiate and sustain eating plan adherence. Sessions support incremental progress towards meeting all five eating behavior goals by helping youth develop action plans, troubleshoot barriers to adherence, and refine action plans to improve adherence. Youth log in MyFitnessPal three days per week. Logs are used to assess and troubleshoot adherence, support youth in developing and refining action plans, and reward youth with points. Incentives are allocated using a point scheme designed to promote logging and goal achievement. Formal adjustment of eating plan at three months is based on weight status, adherence according to logs, and youth/guardian acceptability. |
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angelica Cristello Sarteau | University of North Carolina at Chapel Hill | 919-445-1191 | angcri@live.unc.edu |
Not provided
| 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 | Jul 27, 2022 | Feb 23, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 20, 2022 | Jun 21, 2023 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Between Week 22 and Week 24 |
| Mean Acceptability Score (Youth) | Mean composite acceptability score (range: 5-20) calculated from Likert responses (1- Strongly Agree, 2- Agree, 3- Disagree, 4- Strongly Disagree) to 5 items from an instrument that captures ease of eating pattern adoption, satisfaction, food enjoyment, sustainability, and ease of blood sugar management as perceived by youth. Lower composite acceptability scores indicate greater acceptability (5 - highly acceptable 20 - highly unacceptable). | Week 26 |
| Acceptability Percentage (Youth) | Percentage of youth with a mean acceptability score (range: 5-20) <=10. Lower acceptability scores indicate greater acceptability (5 - highly acceptable 20 - highly unacceptable) where a score >10 indicates the eating pattern is unacceptable. Scores calculated from Likert responses (1- Strongly Agree 2- Agree 3- Disagree 4- Strongly Disagree) to 5 scored items from an instrument that captures ease of eating pattern adoption, satisfaction, food enjoyment, sustainability, and ease of blood sugar management as perceived by youth. | Week 26 |
| Mean Acceptability Score (Guardian) | Mean composite acceptability score (range: 5-20) calculated from Likert responses (1- Strongly Agree, 2- Agree, 3- Disagree, 4- Strongly Disagree) to 5 items from an instrument that captures ease of eating pattern adoption, satisfaction, food enjoyment, sustainability, and ease of blood sugar management as perceived by youth's guardian. Lower composite acceptability scores indicate greater acceptability (5 - highly acceptable 20 - highly unacceptable). | Week 26 |
| Acceptability Percentage (Guardian) | Percentage of guardians with a mean acceptability score (range: 5-20) <=10. Lower acceptability scores indicate greater acceptability (5 - highly acceptable 20 - highly unacceptable) where a score >10 indicates the eating pattern is unacceptable. Scores calculated from Likert responses (1- Strongly Agree 2- Agree 3- Disagree 4- Strongly Disagree) to 5 scored items from an instrument that captures ease of eating pattern adoption, satisfaction, food enjoyment, sustainability, and ease of blood sugar management as perceived by youth's guardian. | Week 26 |
| Cincinnati |
| Ohio |
| 45267-0394 |
| United States |
| 25562265 | Background | Writing Group for the DCCT/EDIC Research Group; Orchard TJ, Nathan DM, Zinman B, Cleary P, Brillon D, Backlund JY, Lachin JM. Association between 7 years of intensive treatment of type 1 diabetes and long-term mortality. JAMA. 2015 Jan 6;313(1):45-53. doi: 10.1001/jama.2014.16107. |
| 25998289 | Background | Miller KM, Foster NC, Beck RW, Bergenstal RM, DuBose SN, DiMeglio LA, Maahs DM, Tamborlane WV; T1D Exchange Clinic Network. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care. 2015 Jun;38(6):971-8. doi: 10.2337/dc15-0078. |
| 25182313 | Background | Smart CE, Annan F, Bruno LP, Higgins LA, Acerini CL; International Society for Pediatric and Adolescent Diabetes. ISPAD Clinical Practice Consensus Guidelines 2014. Nutritional management in children and adolescents with diabetes. Pediatr Diabetes. 2014 Sep;15 Suppl 20:135-53. doi: 10.1111/pedi.12175. No abstract available. |
| 7698052 | Background | Weissberg-Benchell J, Glasgow AM, Tynan WD, Wirtz P, Turek J, Ward J. Adolescent diabetes management and mismanagement. Diabetes Care. 1995 Jan;18(1):77-82. doi: 10.2337/diacare.18.1.77. |
| 18721165 | Background | Overby NC, Margeirsdottir HD, Brunborg C, Anderssen SA, Andersen LF, Dahl-Jorgensen K; Norwegian Study Group for Childhood Diabetes. Physical activity and overweight in children and adolescents using intensified insulin treatment. Pediatr Diabetes. 2009 Apr;10(2):135-41. doi: 10.1111/j.1399-5448.2008.00454.x. Epub 2008 Aug 20. |
| 17687538 | Background | Overby NC, Margeirsdottir HD, Brunborg C, Andersen LF, Dahl-Jorgensen K. The influence of dietary intake and meal pattern on blood glucose control in children and adolescents using intensive insulin treatment. Diabetologia. 2007 Oct;50(10):2044-51. doi: 10.1007/s00125-007-0775-0. Epub 2007 Aug 9. |
| 29708292 | Background | Li C, D'Agostino RB Jr, Dabelea D, Liese AD, Mayer-Davis EJ, Pate R, Merchant AT. Longitudinal association between eating frequency and hemoglobin A1c and serum lipids in diabetes in the SEARCH for Diabetes in Youth study. Pediatr Diabetes. 2018 Apr 30:10.1111/pedi.12690. doi: 10.1111/pedi.12690. Online ahead of print. |
| 10376780 | Background | Wolever TM, Hamad S, Chiasson JL, Josse RG, Leiter LA, Rodger NW, Ross SA, Ryan EA. Day-to-day consistency in amount and source of carbohydrate intake associated with improved blood glucose control in type 1 diabetes. J Am Coll Nutr. 1999 Jun;18(3):242-7. doi: 10.1080/07315724.1999.10718858. |
| 27872155 | Background | International Hypoglycaemia Study Group. Glucose Concentrations of Less Than 3.0 mmol/L (54 mg/dL) Should Be Reported in Clinical Trials: A Joint Position Statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2017 Jan;40(1):155-157. doi: 10.2337/dc16-2215. Epub 2016 Nov 21. No abstract available. |
| 506977 | Background | Beaton GH, Milner J, Corey P, McGuire V, Cousins M, Stewart E, de Ramos M, Hewitt D, Grambsch PV, Kassim N, Little JA. Sources of variance in 24-hour dietary recall data: implications for nutrition study design and interpretation. Am J Clin Nutr. 1979 Dec;32(12):2546-59. doi: 10.1093/ajcn/32.12.2546. No abstract available. |
| 1607574 | Background | Posner BM, Smigelski C, Duggal A, Morgan JL, Cobb J, Cupples LA. Validation of two-dimensional models for estimation of portion size in nutrition research. J Am Diet Assoc. 1992 Jun;92(6):738-41. No abstract available. |
| 24490619 | Background | Kozey Keadle S, Lyden K, Hickey A, Ray EL, Fowke JH, Freedson PS, Matthews CE. Validation of a previous day recall for measuring the location and purpose of active and sedentary behaviors compared to direct observation. Int J Behav Nutr Phys Act. 2014 Feb 3;11:12. doi: 10.1186/1479-5868-11-12. |
| 25766507 | Background | Clark BK, Pavey TG, Lim RF, Gomersall SR, Brown WJ. Past-day recall of sedentary time: Validity of a self-reported measure of sedentary time in a university population. J Sci Med Sport. 2016 Mar;19(3):237-241. doi: 10.1016/j.jsams.2015.02.001. Epub 2015 Feb 21. |
| 22853720 | Background | Maahs DM, Mayer-Davis E, Bishop FK, Wang L, Mangan M, McMurray RG. Outpatient assessment of determinants of glucose excursions in adolescents with type 1 diabetes: proof of concept. Diabetes Technol Ther. 2012 Aug;14(8):658-64. doi: 10.1089/dia.2012.0053. |
| 20032278 | Background | Markowitz JT, Butler DA, Volkening LK, Antisdel JE, Anderson BJ, Laffel LM. Brief screening tool for disordered eating in diabetes: internal consistency and external validity in a contemporary sample of pediatric patients with type 1 diabetes. Diabetes Care. 2010 Mar;33(3):495-500. doi: 10.2337/dc09-1890. Epub 2009 Dec 23. |
| 18346503 | Background | Couch SC, Saelens BE, Levin L, Dart K, Falciglia G, Daniels SR. The efficacy of a clinic-based behavioral nutrition intervention emphasizing a DASH-type diet for adolescents with elevated blood pressure. J Pediatr. 2008 Apr;152(4):494-501. doi: 10.1016/j.jpeds.2007.09.022. Epub 2007 Nov 5. |
| 29277316 | Background | Kichler JC, Seid M, Crandell J, Maahs DM, Bishop FK, Driscoll KA, Standiford D, Hunter CM, Mayer-Davis E. The Flexible Lifestyle Empowering Change (FLEX) intervention for self-management in adolescents with type 1 diabetes: Trial design and baseline characteristics. Contemp Clin Trials. 2018 Mar;66:64-73. doi: 10.1016/j.cct.2017.12.006. Epub 2017 Dec 24. |
| 30119757 | Background | Mayer-Davis EJ, Maahs DM, Seid M, Crandell J, Bishop FK, Driscoll KA, Hunter CM, Kichler JC, Standiford D, Thomas JM; FLEX Study Group. Efficacy of the Flexible Lifestyles Empowering Change intervention on metabolic and psychosocial outcomes in adolescents with type 1 diabetes (FLEX): a randomised controlled trial. Lancet Child Adolesc Health. 2018 Sep;2(9):635-646. doi: 10.1016/S2352-4642(18)30208-6. Epub 2018 Jul 30. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Primary | Percent Time in Range (Week 22-24) | Percentage of time spent in the glycemic range of 70-180 mg/dL during Week 22-24 of blinded continuous glucose monitor (CGM) wear time. | Data from study-provided continuous glucose monitors was not available for 7 participants. | Posted | Mean | Standard Deviation | percentage of CGM wear time | Week 22-24 |
|
|
|
|
| Primary | Adherence to Each Eating Behavior Goal | Percentage of participants who adhered to each eating behavior goal assessed through two unannounced 24-hour dietary recalls (1 weekday and 1 weekend day) collected during Week 22-24: Goal 1. 3-4 meals and 0-2 snacks; Goal 2. Spacing of meals/snacks >2 hours and <4 hours apart; Goal 3. Carbohydrate gram target ranges at meals (>15% daily carbohydrate) and snacks; Goal 4. No snacking after dinner; Goal 5. Meal/snack consumed ≤2 hours of waking; | Data are reported for a total of 41 unique participants between weekday and weekend 24-hour dietary recall. Neither a weekday nor weekend day 24-hour dietary recall was completed for 3 participants. Of the 41 participants, one did not complete a weekday 24-hour dietary recall and 3 participants did not complete a weekend 24-hour dietary recall. | Posted | Number | percentage of participants | Between Week 22 and Week 24 |
|
|
|
| Primary | Adherence to 0-5 Eating Behavior Goals | Percentage of participants who adhered to 0-5 eating behavior goals assessed through two unannounced 24-hour dietary recalls (1 weekday and 1 weekend day) collected during Week 22 - 24. Goal 1. 3-4 meals and 0-2 snacks; Goal 2. Spacing of meals/snacks >2 hours and <4 hours apart Goal 3. Carbohydrate gram target ranges at meals (>15% daily carbohydrate) and snacks Goal 4. No snacking after dinner Goal 5. Meal/snack consumed ≤2 hours of waking | Data are reported for a total of 41 unique participants between weekday and weekend 24-hour dietary recall. Neither a weekday nor weekend day 24-hour dietary recall was completed for 3 participants. Of the 41 participants, one did not complete a weekday 24-hour dietary recall and 3 participants did not complete a weekend 24-hour dietary recall. | Posted | Number | percentage of participants | Between Week 22 and Week 24 |
|
|
|
| Primary | Mean Adherence to Overall Eating Behavior Pattern | Mean number of eating behavior goals (range: 0-5) adhered to by participants as assessed through two unannounced 24-hour dietary recalls (1 weekday and 1 weekend day) collected during Week 22 - 24: Goal 1. 3-4 meals and 0-2 snacks; Goal 2. Spacing of meals/snacks >2 hours and <4 hours apart; Goal 3. Carbohydrate gram target ranges at meals (>15% daily carbohydrate) and snacks; Goal 4. No snacking after dinner; Goal 5. Meal/snack consumed ≤2 hours of waking; | Data are reported for a total of 41 unique participants between weekday and weekend 24-hour dietary recall. Neither a weekday nor weekend day 24-hour dietary recall was completed for 3 participants. Of the 41 participants, one did not complete a weekday 24-hour dietary recall and 3 participants did not complete a weekend 24-hour dietary recall. | Posted | Mean | Standard Deviation | goals | Between Week 22 and Week 24 |
|
|
|
| Primary | Mean Acceptability Score (Youth) | Mean composite acceptability score (range: 5-20) calculated from Likert responses (1- Strongly Agree, 2- Agree, 3- Disagree, 4- Strongly Disagree) to 5 items from an instrument that captures ease of eating pattern adoption, satisfaction, food enjoyment, sustainability, and ease of blood sugar management as perceived by youth. Lower composite acceptability scores indicate greater acceptability (5 - highly acceptable 20 - highly unacceptable). | Posted | Mean | Standard Deviation | score on a scale | Week 26 |
|
|
|
| Primary | Acceptability Percentage (Youth) | Percentage of youth with a mean acceptability score (range: 5-20) <=10. Lower acceptability scores indicate greater acceptability (5 - highly acceptable 20 - highly unacceptable) where a score >10 indicates the eating pattern is unacceptable. Scores calculated from Likert responses (1- Strongly Agree 2- Agree 3- Disagree 4- Strongly Disagree) to 5 scored items from an instrument that captures ease of eating pattern adoption, satisfaction, food enjoyment, sustainability, and ease of blood sugar management as perceived by youth. | Posted | Number | percentage of participants | Week 26 |
|
|
|
| Primary | Mean Acceptability Score (Guardian) | Mean composite acceptability score (range: 5-20) calculated from Likert responses (1- Strongly Agree, 2- Agree, 3- Disagree, 4- Strongly Disagree) to 5 items from an instrument that captures ease of eating pattern adoption, satisfaction, food enjoyment, sustainability, and ease of blood sugar management as perceived by youth's guardian. Lower composite acceptability scores indicate greater acceptability (5 - highly acceptable 20 - highly unacceptable). | Posted | Mean | Standard Deviation | score on a scale | Week 26 |
|
|
|
| Primary | Acceptability Percentage (Guardian) | Percentage of guardians with a mean acceptability score (range: 5-20) <=10. Lower acceptability scores indicate greater acceptability (5 - highly acceptable 20 - highly unacceptable) where a score >10 indicates the eating pattern is unacceptable. Scores calculated from Likert responses (1- Strongly Agree 2- Agree 3- Disagree 4- Strongly Disagree) to 5 scored items from an instrument that captures ease of eating pattern adoption, satisfaction, food enjoyment, sustainability, and ease of blood sugar management as perceived by youth's guardian. | Posted | Number | percentage of guardians | Week 26 |
|
|
|
| Secondary | Change in Hemoglobin A1c Percentage | Change in point-of-care hemoglobin A1c (HbA1c) percentage. | HbA1c was not completed for the endline visit at Week 26 for 3 participants who completed this visit remotely. | Posted | Mean | Standard Deviation | percentage of red blood cells | Baseline (Week 0) and Endline (Week 26) |
|
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001522 | Behavior, Animal |
| D001519 | Behavior |
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| Goal 3 Weekday |
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| Goal 4 Weekday |
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| Goal 5 Weekday |
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| Goal 1 Weekend |
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| Goal 2 Weekend |
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| Goal 3 Weekend |
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| Goal 4 Weekend |
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| Goal 5 Weekend |
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| Adherent to 2 Goals Weekday |
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| Adherent to 3 Goals Weekday |
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| Adherent to 4 Goals Weekday |
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| Adherent to 5 Goals Weekday |
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| Adherent to 0 Goals Weekend |
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| Adherent to 1 Goal Weekend |
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| Adherent to 2 Goals Weekend |
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| Adherent to 3 Goals Weekend |
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| Adherent to 4 Goals Weekend |
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| Adherent to 5 Goals Weekend |
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