A 12-week Pilot Nutrition Intervention for Children With New Diagnosis of Stage 3 Type 1 Diabetes (T1D)

N/AActive Not RecruitingNCT06640478

Milton S. Hershey Medical Center20 enrolled

Overview

The purpose of this research study is to investigate the effects of a combination of weekly distribution of healthy foods and intensive nutrition counseling as complementary therapies to the standard insulin therapy in children with new diagnosis of stage 3 type 1 diabetes (T1D). Feasibility, acceptability, and fidelity of this intervention will be measured. We will also explore the likelihood of prolonging the honeymoon phase of T1D in the intervention study group. Comparisons will be made between this combined nutrition intervention and free healthy foods vs. current standard nutrition counseling. Both study groups will receive standard of care treatment for T1D (insulin therapy). The results of this study could inform future research that will ultimately lead to design of a larger clinical trial testing implementation of novel medical nutrition therapies for children newly diagnosed with stage 3 of T1D, and may lead to prolongation of the honeymoon phase. The overall goal is to promote the beta cell function survival and to reduce the progression to stage 4 of T1D. Condition or Disease: * Type 1 Diabetes Mellitus * New Diagnosis of Stage 3 Type 1 Diabetes ≤ 60days Intervention/Treatment: \- Weekly Free Healthy Foods + Intensive Nutrition Counseling for 12 weeks

The proposed study is a 12-week pilot, single-blinded, randomized, controlled clinical trial in prepubertal children (6-17 years old) newly diagnosed with stage 3 of type 1 diabetes (T1D) within 60 days. The total duration of the study is 24 weeks, but the nutrition intervention is only delivered during 12 weeks with a 24-week follow up visit. We expect to enroll a total of 12-40 children (6-20 per study group). We will be investigating the potential role of a frequent personalized nutrition counseling intervention (7 sessions in a hybrid model) in addition to weekly distribution of selected healthy foods. We expect the diet quality of the youth receiving the intervention (you) will improve during and after the study intervention. There will be two study groups: intervention and control group. The intervention group will receive a food bag containing specific healthy foods with high anti-inflammatory properties weekly for 12 weeks, in addition to seven nutrition counseling sessions. The provided foods are a combination of 6 types of foods including: a) seasonal fruits (containing high amounts of vitamin C and vitamin E), b) legumes, c) nuts, d) yogurt, e) vegetables and f) seafood. The portions of each food group component of the "healthy foods bag" will follow the current USDA dietary guidelines according to the age of the study participant. \[1\] By contrast, the control group will receive weekly grocery store gift cards of similar monetary value of the "healthy food bag" in addition to seven nutrition counseling sessions based on the standard MyHealthy plate model. In regards to the nutrition counseling sessions, this counseling will be provided as a hybrid model with a combination of 4 in-person nutrition counseling sessions and 3 virtual dietary counseling sessions provided by a registered dietitian. In summary: 1. Intervention group will receive NUTRI-Beta foods basket + nutrition counseling (NUTRI-Beta dietary counseling) + standard insulin treatment (either insulin injections or insulin pump per patient preference)+ standard of care insulin therapy and use of a 24-hour continuous glucose monitor, and 2. Control group will receive the standard nutrition counseling per the American Dietary Association (ADA) Guidelines \[2\] + weekly grocery store gift cards + standard of care insulin therapy and use of a 24-hour continuous glucose monitor. The NUTRI-Beta clinical trial study visits will include a total of 10 visits during the 24 weeks of the study: Screening visit (V0), baseline visit (enrolment visit= V1), nutrition counseling visit 2 (week 2 post enrollment), nutrition counseling visit 3 (V3-virtual, week 3), nutrition counseling visit 4 (V4-in person, week 4), nutrition counseling visit 5 (V5-virtual, week 6), nutrition counseling visit 6 (V6-in person, week 8), nutrition counseling visit 7 (V7-virtual, week 10), visit 8 ( 12 weeks after enrollment- end of nutrition intervention), and visit 9 (24 weeks after enrollment). We expect that this nutrition intervention (NUTRI-Beta) will be acceptable to children with new diagnosis of clinical diabetes (stage 3 of T1D) and will improve their diet intake and quality, their nutrition status and may increase their likelihood of residual beta-cell function in the treatment group. Evaluation of the partial remission of T1D will be completed through the determination of the insulin dose-adjusted A1C (IDAA1C) and residual beta cell function through the measurement of peak C-peptide levels during a 2-hour mixed-meal tolerance test (MMTT) after 12 and 24 weeks of the nutrition intervention. The treatment group is expected to have higher rates of partial remission of T1D measured by the IDAA1C, better diet quality, better glycemic metrics and reduced needs of total daily dose of insulin (TDD) (unit/kg/day).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Type 1 Diabetes

Interventions

NUTRI-Beta CounselingOTHER

Dietary Counseling focused on anti-inflammatory foods

Standard dietary counselingDIETARY_SUPPLEMENT

Standard of Care therapy: Nutrition counseling per the ADA clinical guidelines and USDA MyPlate model

Free weekly produce foodsDIETARY_SUPPLEMENT

Free weekly produce

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Willing and able to give assent and to have a parent or legal guardian to provide informed consent 2. Less or equal than 60 days from T1D diagnosis based on American Diabetes Association criteria, and metabolically stable per study physician assessment 3. Boys and girls (Any Tanner stage), 6-17 years of age, at time of enrollment visit 4. Evidence of at least one positive T1D autoantibody (excluding insulin antibodies in those who have received ≥ 2 weeks of exogenous insulin therapy) either through clinically obtained labs at time of diagnosis or as obtained at the screening visit 5. Children with new diagnosis of T1D need to be established patients from Penn State Health- Pediatric diabetes clinic at the time of the enrollment visit 6. Capability to eat different types of food by mouth 7. Daily use of a 24-hour continuous glucose monitor by the time of the enrollment visit 8. Willing and being able to give assent and have a parent or legal guardian provide informed consent Exclusion Criteria: 1. Children with new diagnosis of T1D who are not metabolically stable (E.g. acute dehydration, severe hyperglycemia with moderate/large ketones at the time of the enrollment visit) 2. Concurrent or recent (within the past 30 days of screening) use of non-insulin therapies to control hyperglycemia including immunosuppressive therapies 3. Chronic inflammatory or autoimmune diseases with exception of stable autoimmune thyroid disease 4. Children requiring enteral feeds or parenteral nutrition support 5. Diagnosis of celiac disease or being actively evaluated for possible celiac disease, inflammatory bowel disease or any underlying illness cause acute or chronic intestinal malabsorption. 6. Use of glucocorticoids or other immunosuppressive agents within 30 days of T1D diagnosis 7. Use of medications known to influence glucose intolerance within 30 days of T1D diagnosis 8. Food allergies (nuts, soy, seafood, milk-protein, or as deemed by the principal investigator) that are a barrier for consumption of a balanced diet that meets nutrient requirements 9. Prior diagnosis or positive screening of food sensory disorders 10. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation to the study results

Locations (2)

Penn State Health Children's

Hershey, Pennsylvania, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

Recruitment rates

Number of subjects screened over the course of the study

Time frame: 6 months

Enrollment rates

Number of subjects participating over the course of the study

Time frame: 6 months

Amount of time required to recruit the target sample (approx. 12- 20 people)

Number of months necessary to meet recruitment goals

Time frame: 6 months

Number of subjects required to be screened to meet required sample size (approx. 12- 20 people)

Number of subjects screened to meet enrollment goals

Time frame: 6 months

Number of participants who completed the 12-week intervention

Number of subjects completing the intervention

Time frame: 12 weeks

Average number of provided foods consumed during the day over the course of the intervention

Time frame: 12 weeks

Number of participants who completed the Mixed-meal tolerance test at the enrollment visit

Number of subjects completing the MMTT at baseline

Time frame: Baseline

Number of participants who completed the Mixed-meal tolerance test at the 12-week visit

Number of subjects completing the MMTT at 12 week visit

Time frame: 12 weeks

Number of participants who completed the Mixed-meal tolerance test at the 24-week visit

Number of subjects completing the MMTT at 24 week visit

Time frame: 24 weeks

Secondary Outcomes

Healthy Eating Index (HEI) change from baseline to the 12-week visit

HEI ranges from 0-100, with an ideal score being 100.

Time frame: 12 weeks

Healthy Eating Index (HEI) change from baseline to the 24-week visit.

HEI ranges from 0-100, with an ideal score being 100.

Time frame: 24 weeks

Weight changes from baseline visit to the 12-week visit

Change in subject weight

Time frame: 12weeks

Weight changes from baseline visit to the 24-week visit

Change in subject weight

Time frame: 24 weeks

Weight Z-score changes from baseline visit to the 12 week visit

Change in subject weight z-score

Time frame: 12 weeks

Weight Z-score changes from baseline visit to the 24 week visit

Change in subject weight z-score

Time frame: 24 weeks

Height changes from baseline to the 12 week visit

Change in subject height

Time frame: 12 weeks

Height changes from baseline to the 24 week visit

Change in subject height

Time frame: 24 weeks

Height Z-score changes from baseline to the 12 week visit

Change in subject height z score

Time frame: 12 weeks

Height Z-score changes from baseline to the 24 week visit

Data from ClinicalTrials.gov

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Change in subject height z score

Time frame: 24 weeks

Body Mass Index (BMI) changes from baseline to the 12 week visit

Change in subject BMI

Time frame: 12 weeks

Body Mass Index (BMI) changes from baseline to the 24 week visit

Change in subject BMI

Time frame: 24 weeks

BMI Z-score changes from baseline to 12 weeks

Change in subject BMI z-score

Time frame: 12 weeks

BMI Z-score changes from baseline to 24 weeks

Change in subject BMI z-score

Time frame: 24 weeks

Height velocity changes from baseline visit to the 12-week visit

Change in subject height velocity

Time frame: 12 weeks

Height velocity changes from baseline visit to the 24-week visit

Change in subject height velocity

Time frame: 24 weeks

Percentage of time in range (TIR) glucose levels from baseline to 3 month intervention visit

Change in percentage of TIR glucose levels from baseline to 3 month intervention visit

Time frame: 3 months

Percentage of time in range (TIR) glucose levels from baseline to 6-month post intervention visit

Change in percentage of TIR glucose levels from baseline to 24-week visit

Time frame: 24 weeks

Percentage of time above range (TAR) glucose levels from baselines to 3 month intervention visit

Change in percentage of TAR glucose levels from baseline to 3 month intervention visit

Time frame: 3 months

Percentage of time above range (TAR) glucose levels from baseline to the 6 -month post intervention visit

Change in percentage of TAR glucose levels from baseline to 6 month post intervention visit

Time frame: 6 months

Percentage of time below range (TBR) glucose levels from baselines to 3 month intervention visit

Change in percentage of TBR glucose levels from baseline to 3 month intervention visit

Time frame: 3 months

Percentage of time below range (TBR) glucose levels from baselines to 6 month post intervention visit

Change in percentage of TBR glucose levels from baseline to 6 month post intervention visit

Time frame: 6 months

Percentage of mean glucose level from baseline to 12-week visit

Change in percentage of mean blood glucose level from baseline to 12-week visit

Time frame: 12 weeks

Percentage of average glucose levels from baseline to 6 month post intervention visit

Change in percentage of average glucose levels from baseline to 6 month post intervention visit

Time frame: 6 months

Percentage of standard deviation of glucose levels from baseline to 3 month intervention visit

Change in percentage of standard deviation glucose levels from baseline to 3 month intervention visit

Time frame: 3 months

Percentage of standard deviation of glucose levels from baseline to 6 month post intervention visit

Change in percentage of standard deviation of glucose levels from baseline to 6 month post intervention visit

Time frame: 6 months

Percentage of coefficient of variation (CV) of glucose levels from baseline to 3 month intervention visit

Change in percentage of CV of glucose levels from baseline to 3 month intervention visit

Time frame: 3 months

Percentage of coefficient of variation (CV) of glucose levels from baseline to 6 month post intervention visit

Change in percentage of CV of glucose levels from baseline to 6 month post intervention visit

Time frame: 6 months

Percentage of glucose management index (GMI) of glucose levels from baseline to 3 month intervention visit

Change in percentage of GMI of glucose levels from baseline to 3 month intervention visit

Time frame: 3 months

Percentage of glucose management index (GMI) of glucose levels from baseline to 6 month post intervention visit

Change in percentage of GMI of glucose levels from baseline to 6 month post intervention visit

Time frame: 6 months

Percentage of hemoglobin A1C (HbA1C) of glucose levels from baseline to 3-month intervention visit

Change in percentage of HbA1C glucose levels from baseline to 3-month intervention visit

Time frame: 3 months

Percentage of hemoglobin A1C (HbA1C) of glucose levels from baseline to 6 month post intervention visit

Change in percentage of HbA1C glucose levels from baseline to 6 month post intervention visit

Time frame: 6 months

Dietary intake changes on daily total K- calories from baseline visit to 12 week visit

Change in dietary intake on daily total K-calories will be obtained through the use of the ASA24 dietary online tool, measuring daily total K-calories.

Time frame: 12 weeks

Dietary intake changes on daily total K- calories from baseline visit to 24 week visit

Change in dietary intake on daily total K-calories will be obtained through the use of the ASA24 dietary online tool, measuring daily total K-calories.

Time frame: 24 weeks

Macronutrient intake composition from baseline to 12 week visit

Change in macronutrient intake composition will be obtained through the use of the ASA24 dietary online tool, measuring daily percentage of macronutrients (carbohydrates, proteins, and fats)

Time frame: 12 weeks

Macronutrient intake composition from baseline to 24 week visit

Change in macronutrient intake composition will be obtained through the use of the ASA24 dietary online tool, measuring daily percentage of macronutrients (carbohydrates, proteins, and fats)

Time frame: 24 weeks

Micronutrient intake composition from baseline to 12 week visit

Change in micronutrient intake composition will be obtained through the use of the ASA24 dietary online tool, measuring daily percentage of micronutrients

Time frame: 12 weeks

Micronutrient intake composition from baseline to 24 week visit

Change in micronutrient intake composition will be obtained through the use of the ASA24 dietary online tool, measuring daily percentage of micronutrients

Time frame: 24 weeks

Changes in the baseline levels of carotenoids, vitamin C and vitamin E

Changes in levels of carotenoids, vitamin C and vitamin E from baseline to 12-week visit

Time frame: 12 weeks

Changes in the baseline levels of carotenoids, vitamin C and vitamin E

Changes in levels of carotenoids, vitamin C and vitamin E from baseline visit to 24-week visit

Time frame: 24 weeks

Changes on the levels of 25-hydroxy vitamin D

Changes on the baseline level of 25-hydroxy vitamin D level to the 12-week visit

Time frame: 12 weeks

Changes on the levels of 25-hydroxy vitamin D

Changes on the baseline level of 25-hydroxy vitamin D level to 24-week visit

Time frame: 24 weeks

Omega 3 index (O3i) levels changes during the clinical trial

Changes of baseline levels of Omega 3 index (O3i) to 12-week visit

Time frame: 12 weeks

Omega 3 index levels during clinical trial

Changes of Omega 3 index level from baseline visit to the 24-week study visit

Time frame: 24 weeks

Middle Upper Arm Circumference (MUAC) changes

Middle Upper Arm Circumference (MUAC) changes From enrollment visit to 12-week visit (end of nutrition intervention)

Time frame: 12 weeks

Middle Upper Arm Circumference (MUAC)

Middle Upper Arm Circumference (MUAC) changes from enrollment visit to 24-week visit (end of the study)

Time frame: 24 weeks