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Type 1 DiabetesNCT05147324

"MyPlan" - Individualized Planned Eating Patterns for Adolescents With Type 1 Diabetes

A study testing "MyPlan" - Individualized Planned Eating Pattern in people with Type 1 Diabetes, run by University of North Carolina, Chapel Hill at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
"MyPlan" - Individualized Planned Eating Pattern
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
2 sitesUnited States
Study dates
13 Dec 2021to 24 Apr 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Youth 12-17 years old
  • History of T1D of at least one year
  • HbA1c 7.5-11%
  • Guardian willing to also participate
  • English as preferred language

Who cannot join

  • Youth with other metabolic disorders, unstable thyroid disease, diagnosed eating disorders, prohibitively strict dietary restrictions, or those with other serious condition that renders participation inappropriate.
  • Females who are pregnant, breast feeding, planning to become pregnant during the study period or delivered a baby in the last 12 months.
  • Unwillingness to follow a personalized eating plan for 6 months or complete MyFitnessPal logs at least 3 days/week throughout the study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • University of Cincinnati

    Cincinnati, Ohio, 45267-0394

Other trials in United States

About this study

Official title: Individualized Planned Eating Patterns to Improve Glycemic Management in Adolescents With Type 1 Diabetes: A Pilot Clinical Trial

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.

Read the detailed description

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.

Conditions
Type 1 Diabetes
Being tested
"MyPlan" - Individualized Planned Eating Pattern
Keywords
Diabetes Mellitus, Type 1, Feeding Behavior, Glycemic Control
Medical subject headings
Diabetes Mellitus, Type 1, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • "MyPlan" - Individualized Planned Eating PatternBehavioural

    Also called "MyPlan"

    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.

Study groups in NCT05147324
Study groupRoleWhat they receive
"MyPlan" - Individualized Planned Eating PatternExperimentalAll 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.
Receives: Behavioral: "MyPlan" - Individualized Planned Eating Pattern

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (Week 0-2)

  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.

    Measured: Week 22-24

  3. 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;

    Measured: Between Week 22 and Week 24

  4. 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

    Measured: Between Week 22 and Week 24

  5. 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;

    Measured: Between Week 22 and Week 24

  6. 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).

    Measured: Week 26

  7. 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.

    Measured: Week 26

  8. 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).

    Measured: Week 26

  9. 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.

    Measured: Week 26

Secondary outcomes (1)

  1. Change in Hemoglobin A1c Percentage

    Change in point-of-care hemoglobin A1c (HbA1c) percentage.

    Measured: Baseline (Week 0) and Endline (Week 26)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2021
  2. Study start13 Dec 2021
  3. Primary completion24 Apr 2023
  4. Study completion24 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05147324
Sponsor's protocol ID
21-1337
Other IDs
1R21DK125033-01A1
Status last verified
Mar 2024
First submitted
29 Nov 2021
Last updated
23 Apr 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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).

Publications

  • 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.

    PubMed 8040759

  • 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.

    PubMed 16371630

  • 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.

    PubMed 25562265

  • 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.

    PubMed 25998289

  • 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.

    PubMed 25182313

  • 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.

    PubMed 7698052

  • 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.

    PubMed 18721165

  • 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.

    PubMed 17687538

  • 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.

    PubMed 29708292

  • 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.

    PubMed 10376780

  • 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.

    PubMed 27872155

  • 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.

    PubMed 506977

  • 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.

    PubMed 1607574

  • 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.

    PubMed 24490619

  • 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.

    PubMed 25766507

Questions about this trial

What is this clinical trial studying?

A study testing "MyPlan" - Individualized Planned Eating Pattern in people with Type 1 Diabetes, run by University of North Carolina, Chapel Hill at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Time in Range (Baseline) (time frame: Baseline (Week 0-2)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05147324, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.

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