Diabetes Clinical Trial
— NuRISHOfficial title:
Nutrition Recommendation Intervention trialS in Children's Healthcare
NuRISH is a suite of clinical trials for children from low-income families which will determine whether primary healthcare prescription for: 1) Optimal breastfeeding with support from a mobile lactation consultant vs. usual care and 2) High-quality childcare starting at 1 year vs. usual care can prevent childhood obesity, and improve cardiovascular, developmental and mental health at 2 years of age.
Status | Not yet recruiting |
Enrollment | 620 |
Est. completion date | December 2027 |
Est. primary completion date | December 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Day to 1 Week |
Eligibility | Inclusion Criteria: - Healthy by parental report - <32 weeks gestation - 0-1 week of age - First birth /first time parents Exclusion Criteria: - Children with a syndrome associated with obesity or developmental delay |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children | Applied Health Research Centre, Canadian Paediatric Society, McMaster University, Pediatric Alliance of Ontario, Queen Mary University of London, Toronto Public Health, Unity Health Toronto, University of Toronto |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | zBMI | The primary outcome measure will be age and sex standardized BMI z-score (zBMI), which will be measured at the 2-year primary healthcare visit. zBMI is an important outcome that is predictive of adiposity in later childhood, adolescence and adulthood. Data including birthweight and length, and repeated measures of weight and length will be used to calculate zBMI growth trajectories. | 2-year primary healthcare visit | |
Secondary | breastfeeding self-efficacy | change in breastfeeding self-efficacy measured by lactation consultant logs | 6 months | |
Secondary | exclusive breastfeeding duration | change in exclusive breastfeeding duration | 6 months | |
Secondary | Childcare attendance | change in centre-based childcare attendance measured by attendance logs | 2 years of age | |
Secondary | cognitive development | To capture child's development, the Ages and Stages Questionnaire will be administered. The Ages and Stages Questionnaire identifies infants, toddlers and preschool aged children at risk of a developmental delay in five developmental domains: Communication, Gross Motor, Fine Motor, Problem Solving and Personal Social Behaviour. Each domain consists of six questions about important age-specific developmental milestones. If a child scores between 1 and 2 below the normative mean on any domain, rescreening is recommended. When a child scores 1 below the normative mean on two or more domains, or 2 below the normative mean on at least one domain, a referral to a health care professional is recommended. | 2 years of age | |
Secondary | maternal mental health | change in maternal mental health, measured by the Edinburgh Postnatal Depression Scale at 2 years of age. The scale was developed for screening postpartum women in outpatient, home visiting settings, or at the 6 -8 week postpartum examination. Consisting of 10 questions, each response is scored 0, 1, 2, or 3 according to increased severity of the symptom. Items marked with an asterisk (*) are reverse scored (i.e., 3, 2, 1, and 0). The total score is determined by adding together the scores for each of the 10 items. A woman scoring 9 or more points or indicating any suicidal ideation - that is she scores 1 or higher on question #10 - should be referred immediately for follow-up. Even if a woman scores less than 9, if the clinician feels the client is suffering from depression, an appropriate referral should be made. | 2 years of age | |
Secondary | mental health | Child's mental health captured by the Strengths and Difficulties Questionnaire. The questionnaire consists of 25 items subdivided into four difficulties scales, emotional symptoms, conduct problems, inattention-hyperactivity and peer problems, and a separate fifth strength scale, prosocial behavior. All subscales have five questions. Each item has to be scored on a 3-point scale with 0 = 'not true', 1 = 'somewhat true' and 2 = 'certainly true'. A higher score indicates more emotional and behavioral problems. | 2 years of age | |
Secondary | blood pressure | change in cardiovascular risk factors for the child | 2 years of age | |
Secondary | non-HDL | change in cardiovascular risk factors for the child | 2 years of age | |
Secondary | LDL | change in cardiovascular risk factors for the child | 2 years of age | |
Secondary | triglyceride | change in cardiovascular risk factors for the child | 2 years of age | |
Secondary | HDL | change in cardiovascular risk factors for the child | 2 years of age | |
Secondary | TC | change in cardiovascular risk factors for the child | 2 years of age | |
Secondary | glucose | change in cardiovascular risk factors for the child | 2 years of age | |
Secondary | hsCRP | change in cardiovascular risk factors for the child | 2 years of age | |
Secondary | HbA1C | change in cardiovascular risk factors for the child | 2 years of age | |
Secondary | Dietary Quality | total caloric intake captured through the Automated Self-Administered 24-hour Dietary Assessment Tool of the child and mother at 2 years of age | 2 years of age |
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