Childhood Adiposity and Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes (CONCEPTT Kids)

Neurologic Disorder Clinical Trial

Official title:

CONCEPTT Kids Childhood Adiposity and Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes: A Follow up Study of the CONCEPTT Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04098679
• Other study ID #: REB14-2146_MOD2
• Status: Recruiting
• Start date: September 30, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: University of Calgary
• Contact: Sonya Mergler, BA
• Phone: 416-480-5627
• Email: conceptt[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a follow-up study of children born to mothers who participated in the CONCEPTT Trial. CONCEPTT (a multicentre randomized controlled trial of continuous glucose monitoring (CGM) in women with Type 1 diabetes during pregnancy).

The purpose of this study is to examine the association of maternal glycemic measures on childhood intelligence quotient (IQ), behavioural outcomes, language scores and weight measures. The children of the women who participated in CONCEPTT will be assessed.

Description:

The assessments will occur between the children's ages of 3-7 years. The assessment will include obtaining consent and child measurements including weight, height, waist circumference and skinfold thickness (at the triceps, subscapular, flank and quadriceps). Body mass index (BMI) and Waist-Height ratio will be calculated.

The other procedures will include:

1. the Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition (1);

2. ADHD Rating Scale IV (2) and ADHD Rating Scale-IV Preschool Version (3);

3. Social Responsiveness Scale-2 for ASD behaviours (4);

4. Children's performance on the Speed Naming and Phonological Processing subscales of the NEPSY-II (5)

5. Parent reported language development on the Children's Communication Checklist-2 for children over four years of age (6) or the Language Use Inventory (LUI) for children 36 to 47 months of age (7).

Basic demographic questions will be asked regarding the child's mother and father including age, ethnicity, education, occupation, family arrangement, presence of major illnesses, and diabetes complications. Questions regarding maternal diabetes, maternal and paternal family history of diabetes and risk factors for heart disease will be collected at the clinic visit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

Inclusion Criteria:

• Children of women who participated in the CONCEPTT trial at selected recruiting sites.

Exclusion Criteria:

• Children (of women who participated in the CONCEPTT trial) with major congenital anomalies will be assessed on a case by case basis to determine eligibility.

Related Conditions & MeSH terms

• Adiposity
• Diabetes Mellitus, Type 1
• Nervous System Diseases
• Neurologic Disorder
• Obesity

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Lawson Health Research Institute	London	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	Juvenile Diabetes Research Foundation, SRI International

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Feig DS, Donovan LE, Corcoy R, Murphy KE, Amiel SA, Hunt KF, Asztalos E, Barrett JFR, Sanchez JJ, de Leiva A, Hod M, Jovanovic L, Keely E, McManus R, Hutton EK, Meek CL, Stewart ZA, Wysocki T, O'Brien R, Ruedy K, Kollman C, Tomlinson G, Murphy HR; CONCEPT — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IQ	IQ assessed by the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (WPPSI-IV)	2 years
Secondary	ADHD	Attention Deficit Hyperactive Disorder (ADHD) Rating Scale-IV and Attention Deficit Hyperactive Disorder Rating Scale-IV Preschool Version. It is an 18-item questionnaire that requires the respondent to rate the frequency of occurrence of ADHD symptoms. The respondent rates each item on a scale of 0 (not at all) to 3 (very often).; The scale yields scores for an Inattentive, Hyperactive/Impulsive and Total Scale. The subscales are Inattention Factor and Hyperactive/Impulsive Factor.	2 years
Secondary	ASD	Social Responsiveness Scale-2 questionnaire results for Autism Spectrum Disorder behaviours. It is an 65-item questionnaire that requires the respondent to describe the child's behaviour. The respondent rates each item on a scale of 1 (not true) to 4 (almost always true). The scale yields scores for autism spectrum disorders for total score discussion of social behaviour and social interactions.	2 years
Secondary	NEPSY-II	The NEPSY-II stands for "A Developmental NEuroPSYchological Assessment". Children's language skills assessed using the Speed Naming and Phonological Processing subscales of the NEPSY-II testing results. Phonological Processing is a subtest composed of phonological processing tasks designed to assess phonemic awareness. Speed Naming is a timed subtest designed to assess rapid semantic access to and production of names of colors, shapes, sizes, letters, or numbers.	2 years
Secondary	CCC-2/LUI	Parent reported language development on the Children's Communication Checklist-2 (CCC_2) for children over four years of age or the Language Use Inventory (LUI) for children 36 to 47 months of age questionnaire results. The Children's Communication Checklist - Seconda Edition has 70 Statements that refer to difficulties children may have that affect their ability to communicate. Rating key is 0 (less than once a week or never) to 3 (several times, more than twice, a day, or always). Total score is used.	2 years
Secondary	Demographics	Data form to be completed by parents will ask about their level of education, sex, gender, socioeconomic status, height, and any neurodevelopmental or other medical diagnoses in their enrolled child	2 years
Secondary	Adiposity	Childhood adiposity measures: weight, height, waist circumference and skinfold thickness (at the triceps, subscapular, flank and quadriceps). Body mass index (BMI) and Waist-Height ratio will be calculated using standardized procedures	2 years