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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neurologic Disorder; Adiposity

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 174

Contacts and Locations

• Study Contact: Name: Sonya Mergler, BA; Phone Number: 416-480-5627; Email: conceptt@sunnybrook.ca
• Study Contact Backup: Name: Gail Klein, MSc; Phone Number: 416-480-5632; Email: gail.klein@sunnybrook.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2T 5C7
      • Recruiting
      • University of Calgary
      • Contact: Lois Donovan, MD FRCPC; Phone Number: 403 955-8358
      • Principal Investigator: Lois Donovan, MD FRCPC
  • Ontario
    • London, Ontario, Canada
      • Recruiting
      • Lawson Health Research Institute
      • Principal Investigator: Selina Lui
    • Toronto, Ontario, Canada
      • Recruiting
      • Mount Sinai Hospital
      • Principal Investigator: Denice Feig
    • Toronto, Ontario, Canada
      • Recruiting
      • Sunnybrook Health Sciences Centre
      • Principal Investigator: Ilana Halperin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants, aged 3 to 7 years

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IQ	IQ assessed by the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (WPPSI-IV)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Juvenile Diabetes Research Foundation; SRI International
• Investigators: Principal Investigator: Jennifer Yamamoto, MD MSc FRCPC, University of Calgary

Publications and helpful links

General Publications

• 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; CONCEPTT Collaborative Group. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. Lancet. 2017 Nov 25;390(10110):2347-2359. doi: 10.1016/S0140-6736(17)32400-5. Epub 2017 Sep 15. Erratum In: Lancet. 2017 Nov 25;390(10110):2346.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 19, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 23, 2019

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Type 1 diabetes; Continuous glucose monitoring; Offspring
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Diabetes Mellitus, Type 1; Obesity; Nervous System Diseases
• Other Study ID Numbers: REB14-2146_MOD2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan for individual level data to be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No