Intensive Dietary and Activity Counselling (IDAC)

NCT06670625 | Recruiting

• 1 other identifier: 2024-05217-01
• Study Type: interventional
• Target: 1,244
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this intervention study is to investigate if a intensive dietary and physical activity counselling during the first two years of life in children with increased (genetically) risk for Type 1 Diabetes (T1D) can promote a healthy beta-cell environment, in order to reduce increased weight gain and development of islet autoimmunity (beta-cell autoantibodies). The main hypotheses are:

• Early lifestyle influences the susceptibility to islet autoimmunity (IA) by increasing beta-cell vulnerability. Introducing a "healthy beta-cell lifestyle" from infancy will reduce beta-cell vulnerability and the likelihood of IA.
• Will promotion of a healthy beta-cell environment during early childhood in children with increased genetic risk of T1D reduce beta-cell stress, increased weight gain and development of islet autoantibodies? The primary objective is to determine whether an Intensive Diet and Activity Counseling (IDAC) from age 3 months to age 2 years improves beta-cell health in children with increased risk for islet autoimmunity. Secondary objectives are to determine whether IDAC is associated with infant and early childhood growth and body composition and to determine whether IDAC reduces the cumulative incidence of islet autoantibodies or type 1 diabetes in childhood. Participants will be randomized (ratio 1:1) to control group and intervention group. Breastfeeding status at time of randomization will be taken into account. Participants will be enrolled by the age of four months and visit the research clinic ever third months up until the age of 24 months, and then yearly up until the age of 6 years.
• Anthropometric measurements and blood draw will be taken at each visit.
• Questionnaires focusing on breastfeeding and early infant feeding habits will be used at each visit.
• 24hrs recalls will be done at the age of 6, 9, 12, 18 and 24 months of age.
• Physical activity will be estimated using questionnaires (3, 6, 9 months) and accelerometer data (12, 18 and 24 months).
• Stool samples will be collected at 6, 12 and 18 months of age

Conditions

Type 1 Diabetes; Autoimmune Diabetes

Keywords

islet autoimmunity; children

Outcome Measures

Primary Outcomes (2)

• Beta-cell health

  Assessed by the proinsulin/ C-peptide ratio during OGTT

  at 36 months

• Beta-cell health

  Assessed by the Disposition Index relative to insulin resistance (HOMA-IR) IGI30/HOMA-IR (IGI30=Delta insulin 0-30/Delta Glucose 0-30 during OGTT).

  at 36 months

Secondary Outcomes (3)

• Accelerated growth during infancy

  from birth until the age of 36 months

• Overweight at the age of 36 months

  measurements collected at 36 months

• Development of persistent confirmed islet autoantibodies

  from birth until the age of 36 months

Study Arms (2)

Intervention Group (IDAC+)

EXPERIMENTAL

Participants randomized to the IDAC+ will regularly receive dietary and physical activity advice with focus on continuing breastfeeding up until the age of 12 months, limit the protein intake in the child´s diet (maximum 15E%), limit milk \& milk products (max 150 ml/day), support daily vitamin D supplementation. Specific age-appropriate advice on physical activity will be given to participants.

Behavioral: IDAC+

Control Group

NO INTERVENTION

No specific advice will be given to this group other than national guidelines similar to those given by the childcare centers.

Interventions

IDAC+ BEHAVIORAL

Diet and physical activity counselling at baseline, 6, 12 and 24 months visit.

Intervention Group (IDAC+)

Eligibility Criteria

• Age: 3 Months - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The age of the infant at time of enrolment should be 3.0 months (13 - 17 weeks).
• An increased genetic risk (7-10%) to develop beta-cell autoantibodies by the age of 6 years.
• for males having a genetic risk score greater than or equal to 18.2 but excluding those who are eligible for AVANT1A.
• for females having a genetic risk score greater than or equal to 14.5 but excluding those who are eligible for AVANT1A.
• Children with a T1D-FDR, all DR3/3, DR4-DQ8/DR4-DQ7 and DR4-DQ8/x where x is none of the following protective alleles: DRB1\*1501, DQB1\*0503, DRB1\*1303 will be included regardless of genetic risk score.
• \- Written informed consent signed by the custodial parent(s).

You may not qualify if:

• Any medical condition, concomitant disease or treatment that may interfere with the assessments or may jeopardize the participant's safe participation in the study, as judged by the investigators.
• Preterm delivery \< 36 weeks of gestation.
• Any condition that could be associated with poor compliance.
• Diagnosis of diabetes prior to recruitment or randomization.
• Current use of any investigational drug.

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Clinical Research Center (CRC), Bldng 60:11

Malmo, 20502, Sweden

RECRUITING

Related Publications (5)

• Nitecki M, Gerstein HC, Balmakov Y, Tsur E, Babushkin V, Michaeli T, Afek A, Pinhas-Hamiel O, Cukierman-Yaffe T, Twig G. High BMI and the risk for incident type 1 Diabetes Mellitus: a systematic review and meta-analysis of aggregated cohort studies. Cardiovasc Diabetol. 2023 Nov 2;22(1):300. doi: 10.1186/s12933-023-02007-y.

  PMID: 37919779 BACKGROUND

• Arnesen EK, Thorisdottir B, Lamberg-Allardt C, Barebring L, Nwaru B, Dierkes J, Ramel A, Akesson A. Protein intake in children and growth and risk of overweight or obesity: A systematic review and meta-analysis. Food Nutr Res. 2022 Feb 21;66. doi: 10.29219/fnr.v66.8242. eCollection 2022.

  PMID: 35261578 BACKGROUND

• Liu X, Vehik K, Huang Y, Elding Larsson H, Toppari J, Ziegler AG, She JX, Rewers M, Hagopian WA, Akolkar B, Krischer JP; TEDDY Study Group. Distinct Growth Phases in Early Life Associated With the Risk of Type 1 Diabetes: The TEDDY Study. Diabetes Care. 2020 Mar;43(3):556-562. doi: 10.2337/dc19-1670. Epub 2020 Jan 2.

  PMID: 31896601 BACKGROUND

• Elding Larsson H, Vehik K, Haller MJ, Liu X, Akolkar B, Hagopian W, Krischer J, Lernmark A, She JX, Simell O, Toppari J, Ziegler AG, Rewers M; TEDDY Study Group. Growth and Risk for Islet Autoimmunity and Progression to Type 1 Diabetes in Early Childhood: The Environmental Determinants of Diabetes in the Young Study. Diabetes. 2016 Jul;65(7):1988-95. doi: 10.2337/db15-1180. Epub 2016 Mar 18.

  PMID: 26993064 BACKGROUND

• Aronsson CA, Tamura R, Vehik K, Uusitalo U, Yang J, Haller MJ, Toppari J, Hagopian W, McIndoe RA, Rewers MJ, Ziegler AG, Akolkar B, Krischer JP, Norris JM, Virtanen SM, Larsson HE. Dietary Intake and Body Mass Index Influence the Risk of Islet Autoimmunity in Genetically At-Risk Children: A Mediation Analysis Using the TEDDY Cohort. Pediatr Diabetes. 2023;2023:3945064. doi: 10.1155/2023/3945064. Epub 2023 Feb 17.

  PMID: 37614409 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Helena Elding Larsson, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carin Andrén Aronsson, PhD

CONTACT

+464039113; carin.andren_aronsson@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 1, 2024
• Study Start: March 15, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2031
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)