Diet and Well-being of Young Danish Children

NCT02170428 | Completed

• 2 other identifiers: D201H-KF-2007-0003
• Study Type: observational
• Target: 263
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective with the study was to contribute to the scientific basis for dietary and life strategies, policies and dietary guidelines to infants and young children in Denmark and with special focus on prevention of obesity and diet related chronic diseases such as type 2 diabetes, ischemic heart disease and osteoporosis.

Conditions

Growth Acceleration; Overweight or Obesity; Biomarkers of Metabolic Syndrome; Programming and Tracking

Keywords

growth,; infancy,; children,; diet,; breastfeeding; complementary feeding; early life programming; tracking; physical activity

Outcome Measures

Primary Outcomes (4)

• Change in anthropometric measurements in periods of early childhood.

  Composite outcome consisting of body weight, height, body mass index (BMI) and BMI z-scores, waist-, upper arm- and head circumference, skinfold thickness measured at subscapularis and triceps.

  9, 18 and 36 months of age

• Body composition in early childhood

  Body composition is measures by Dual-energy X-ray Absorptiometry and bio impedance. Fat mass, fat mass index (kg/m2), fat free mass index (kg/m2) are calculated.

  36 months of age

• Metabolic syndrome score in early life

  Composite outcome consisting of triglycerides, high lipoprotein (HDL) and glucose measured in plasma/serum, waist circumference and blood pressure.

  9 and 36 months of age

• Diet in periods of early life

  The diet is recorded using self-reported 7-day record questionnaire.

  9, 18 and 36 months of age

Secondary Outcomes (10)

• Breastfeeding duration in infancy and early childhood

  9, 18 and 36 months of age

• Insulin like growth factor at 9 and 36 months of age

  9 and 36 months of age

• Physical activity, sedentary behavior and sleep in early childhood

  9, 18 and 36 months of age

• Bone mass in 3-year-old children

  36 months of age

• Vitamin D status in infancy

  9 months of age

Study Arms (1)

growth and development

Growth and development of a random sample of healthy Danish infants

Eligibility Criteria

• Age: 9 Months - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy young Danish Children selected through the National Civil Registry and invited to participate by letter.

You may qualify if:

• healthy singletons born at term (week 37-43) between August 2006 and September 2007 with no disease that could influence food intake or growth

You may not qualify if:

• born preterm (before week 37)
• non-Danish speaking parents.

Sponsors & Collaborators

• University of Copenhagen: lead
• Technical University of Denmark: collaborator

Study Sites (1)

Department of Human Nutrition, Faculty of Sciences, University of Copenhagen

Frederiksberg, 1958, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine, faeces, white cells, plama/serum

MeSH Terms

Conditions

Overweight; Obesity; Breast Feeding; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Study Officials

• Kim F Michaelsen, MD Professor

  Faculty of Science, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: June 23, 2014
• Study Start: May 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 13, 2019

Record last verified: 2019-11

Locations

DK (1)