Kansas University DHA Outcome Study (KUDOS) Follow-Up
29. ledna 2018 aktualizováno: Susan Carlson, PhD
This is a continuation study to KUDOS (NCT00266825).
The purpose of this study is to follow-up with participants on the original study to determine if the effects of increasing DHA intake during pregnancy increase cognitive development in 2 to 6 year-old children.
Přehled studie
Detailní popis
Numerous trials show benefits of postnatal DHA supplementation for visual acuity.
There are also numerous observational(not intervention)studies that link higher maternal DHA status during pregnancy to higher cognitive function.
Intervention studies that increase DHA exposure during fetal life and that measure cognitive development of infants are lacking; and no study to date has systematically followed children whose mothers were randomly assigned to DHA supplementation to school age with regular 6 month assessments of age-appropriate assessments of cognitive development.
The absence of such studies is a serious limitation because there is evidence that differences in cognitive function due to such interventions do not become robust until around age 4 years.
Women in the US consume low amounts of DHA compared to other world populations, and this likely means less DHA transfer to the fetus than in many other populations.
Prenatal DHA exposure may be more important than postnatal exposure, because animal studies show critical windows for brain DHA accumulation in relation to effects on neurotransmitters such as serotonin, dopamine and GABA.
Typ studie
Intervenční
Zápis (Aktuální)
190
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Kansas
-
Kansas City, Kansas, Spojené státy, 66160
- University of Kansas Medical Center
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
16 let až 35 let (Dítě, Dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Ženský
Popis
Inclusion Criteria:
- Pregnant females 16.0-35.0 years of age (inclusive) at 8-20 weeks gestation at enrollment (date/ultrasound)
- Agree to consume study capsules from enrollment until delivery
- Agree to return to the study center for delivery
- BMI < 40
- No serious illnesses (e.g., cancer, diabetes, lupus, hepatitis, sexually transmitted diseases, not HIV positive)
- Available by telephone
Exclusion Criteria:
- Less than 16 or greater than 35 years of age
- BMI < 40
- Serious illness such as cancer, lupus, hepatitis, sexually transmitted disease or HIV positive
- Expecting multiple infants
- Diabetes or gestational diabetes at baseline
- Elevated blood pressure due to any cause
- Not planning to return to the study center for delivery
- Gestational age at baseline < 8 weeks or >20 weeks
- Unable or unwilling to agree to consume capsules until delivery
- Unable to provide informed consent in English
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Komparátor placeba: Placebo kapsle
|
600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
|
Experimentální: DHA Capsule
|
600 mg DHA capsule
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ
Časové okno: 36 Months
|
The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains.
At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance).
For the older ages the score can range from 40 to 160.
For all ages the assessment is normed to a Mean = 100, St Dev = 15.
|
36 Months
|
|
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ
Časové okno: 48 Months
|
The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains.
At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance).
For the older ages the score can range from 40 to 160.
For all ages the assessment is normed to a Mean = 100, St Dev = 15.
|
48 Months
|
|
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ
Časové okno: 72 Months
|
The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains.
At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance).
For the older ages the score can range from 40 to 160.
For all ages the assessment is normed to a Mean = 100, St Dev = 15.
|
72 Months
|
|
Cognitive Function Score - Peabody Picture Vocabulary Test
Časové okno: 60 Months
|
The Peabody Picture Vocabulary Test, 3rd Edition provides a standardized assessment of a person's receptive vocabulary.
The Standard Score can range from 40 (poorest performance) to 160 (best performance) and has been normed to a Mean = 100, St Dev = 15.
|
60 Months
|
|
Cognitive Function Score - Test of Preschool Early Literacy
Časové okno: 42 Months
|
The Test of Preschool Early Literacy provides a standardized Early Literacy Index score, a measure of general, early literacy skills that relate to later reading and writing skill acquisition.
The score is based on assessments of vocabulary, print knowledge, and phonological awareness.
The score can range from 40 (poorest performance) to 144 (best performance) and has been normed to a Mean = 100, St Dev = 15.
|
42 Months
|
|
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ
Časové okno: 36 Months
|
The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning.
At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance).
For the older ages the score can range from 46 to 155.
For all ages the assessment is normed to a Mean = 100, St Dev = 15.
|
36 Months
|
|
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ
Časové okno: 48 Months
|
The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning.
At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance).
For the older ages the score can range from 46 to 155.
For all ages the assessment is normed to a Mean = 100, St Dev = 15.
|
48 Months
|
|
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ
Časové okno: 72 Months
|
The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning.
At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance).
For the older ages the score can range from 46 to 155.
For all ages the assessment is normed to a Mean = 100, St Dev = 15.
|
72 Months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Adaptive Regulation Assessment
Časové okno: 36 Months
|
The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent.
Externalizing Problems is a measure of Aggression and Hyperactivity.
Internalizing Problems is a measure of Anxiety, Depression, and Somatization.
The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems.
Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership.
All scores are derived from the general, combined sex normative tables of T-Scores.
For Adaptive Skills higher T-Scores reflect a more optimal outcome.
For all other measures lower T-Scores reflect a more optimal outcome.
All T-Scores were standardized with a Mean = 50, St Dev = 10.
|
36 Months
|
|
Adaptive Regulation Assessment
Časové okno: 48 Months
|
The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent.
Externalizing Problems is a measure of Aggression and Hyperactivity.
Internalizing Problems is a measure of Anxiety, Depression, and Somatization.
The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems.
Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership.
All scores are derived from the general, combined sex normative tables of T-Scores.
For Adaptive Skills higher T-Scores reflect a more optimal outcome.
For all other measures lower T-Scores reflect a more optimal outcome.
All T-Scores were standardized with a Mean = 50, St Dev = 10.
|
48 Months
|
|
Adaptive Regulation Assessment
Časové okno: 60 Months
|
The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent.
Externalizing Problems is a measure of Aggression and Hyperactivity.
Internalizing Problems is a measure of Anxiety, Depression, and Somatization.
The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems.
Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership.
All scores are derived from the general, combined sex normative tables of T-Scores.
For Adaptive Skills higher T-Scores reflect a more optimal outcome.
For all other measures lower T-Scores reflect a more optimal outcome.
All T-Scores were standardized with a Mean = 50, St Dev = 10.
|
60 Months
|
|
Adaptive Regulation Assessment
Časové okno: 72 Months
|
The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent.
Externalizing Problems is a measure of Aggression and Hyperactivity.
Internalizing Problems is a measure of Anxiety, Depression, and Somatization.
The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems.
Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership.
All scores are derived from the general, combined sex normative tables of T-Scores.
For Adaptive Skills higher T-Scores reflect a more optimal outcome.
For all other measures lower T-Scores reflect a more optimal outcome.
All T-Scores were standardized with a Mean = 50, St Dev = 10.
|
72 Months
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Anthropometrics: Weight-for-age
Časové okno: 2 years
|
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
|
2 years
|
|
Anthropometrics: Weight-for-age
Časové okno: 2.5 years
|
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
|
2.5 years
|
|
Anthropometrics: Weight-for-age
Časové okno: 3 years
|
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
|
3 years
|
|
Anthropometrics: Height-for-Age
Časové okno: 2 years
|
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA).
Braids, ponytails or other hair artifacts were removed or subtracted when needed.
|
2 years
|
|
Anthropometrics: Weight-for-age
Časové okno: 3.5 years
|
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
|
3.5 years
|
|
Anthropometrics: Weight-for-age
Časové okno: 4 years
|
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
|
4 years
|
|
Anthropometrics: Weight-for-age
Časové okno: 4.5 years
|
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
|
4.5 years
|
|
Anthropometrics: Weight-for-age
Časové okno: 5 years
|
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
|
5 years
|
|
Anthropometrics: Weight-for-age
Časové okno: 5.5 years
|
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
|
5.5 years
|
|
Anthropometrics: Weight-for-age
Časové okno: 6 years
|
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
|
6 years
|
|
Anthropometrics: Height-for-Age
Časové okno: 2.5 years
|
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA).
Braids, ponytails or other hair artifacts were removed or subtracted when needed.
|
2.5 years
|
|
Anthropometrics: Height-for-Age
Časové okno: 3 years
|
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA).
Braids, ponytails or other hair artifacts were removed or subtracted when needed.
|
3 years
|
|
Anthropometrics: Height-for-Age
Časové okno: 3.5 years
|
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA).
Braids, ponytails or other hair artifacts were removed or subtracted when needed.
|
3.5 years
|
|
Anthropometrics: Height-for-Age
Časové okno: 4 years
|
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA).
Braids, ponytails or other hair artifacts were removed or subtracted when needed.
|
4 years
|
|
Anthropometrics: Height-for-Age
Časové okno: 4.5 years
|
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA).
Braids, ponytails or other hair artifacts were removed or subtracted when needed.
|
4.5 years
|
|
Anthropometrics: Height-for-Age
Časové okno: 5 years
|
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA).
Braids, ponytails or other hair artifacts were removed or subtracted when needed.
|
5 years
|
|
Anthropometrics: Height-for-Age
Časové okno: 5.5 years
|
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA).
Braids, ponytails or other hair artifacts were removed or subtracted when needed.
|
5.5 years
|
|
Anthropometrics: Height-for-Age
Časové okno: 6 years
|
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA).
Braids, ponytails or other hair artifacts were removed or subtracted when needed.
|
6 years
|
|
Anthropometrics: Body Mass Index-for-age
Časové okno: 2 years
|
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
|
2 years
|
|
Anthropometrics: Body Mass Index-for-age
Časové okno: 2.5 years
|
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
|
2.5 years
|
|
Anthropometrics: Body Mass Index-for-age
Časové okno: 3 years
|
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
|
3 years
|
|
Anthropometrics: Body Mass Index-for-age
Časové okno: 3.5 years
|
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
|
3.5 years
|
|
Anthropometrics: Body Mass Index-for-age
Časové okno: 4 years
|
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
|
4 years
|
|
Anthropometrics: Body Mass Index-for-age
Časové okno: 4.5 years
|
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
|
4.5 years
|
|
Anthropometrics: Body Mass Index-for-age
Časové okno: 5 years
|
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
|
5 years
|
|
Anthropometrics: Body Mass Index-for-age
Časové okno: 5.5 years
|
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
|
5.5 years
|
|
Anthropometrics: Body Mass Index-for-age
Časové okno: 6 years
|
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
|
6 years
|
|
Anthropometrics: Head Circumference-for-age
Časové okno: 2 years
|
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue).
Braids, ponytails, glasses or other artifacts were removed whenever possible.
|
2 years
|
|
Anthropometrics: Head Circumference-for-age
Časové okno: 2.5 years
|
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue).
Braids, ponytails, glasses or other artifacts were removed whenever possible.
|
2.5 years
|
|
Anthropometrics: Head Circumference-for-age
Časové okno: 3 years
|
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue).
Braids, ponytails, glasses or other artifacts were removed whenever possible.
|
3 years
|
|
Anthropometrics: Head Circumference-for-age
Časové okno: 3.5 years
|
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue).
Braids, ponytails, glasses or other artifacts were removed whenever possible.
|
3.5 years
|
|
Anthropometrics: Head Circumference-for-age
Časové okno: 4 years
|
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue).
Braids, ponytails, glasses or other artifacts were removed whenever possible.
|
4 years
|
|
Anthropometrics: Head Circumference-for-age
Časové okno: 4.5 years
|
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue).
Braids, ponytails, glasses or other artifacts were removed whenever possible.
|
4.5 years
|
|
Anthropometrics: Head Circumference-for-age
Časové okno: 5 years
|
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue).
Braids, ponytails, glasses or other artifacts were removed whenever possible.
|
5 years
|
|
Anthropometrics: Head Circumference-for-age
Časové okno: 5.5 years
|
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue).
Braids, ponytails, glasses or other artifacts were removed whenever possible.
|
5.5 years
|
|
Anthropometrics: Head Circumference-for-age
Časové okno: 6 years
|
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue).
Braids, ponytails, glasses or other artifacts were removed whenever possible.
|
6 years
|
|
Dietary Intake
Časové okno: 2 years
|
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach.
When necessary both the parent and child participated in the recall process to increase overall reliability.
Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian.
Reliability and caloric intake data are presented here.
Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes.
Caloric intake is the mean kcal per day from reliable recalls only.
|
2 years
|
|
Dietary Intake
Časové okno: 2.5 years
|
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach.
When necessary both the parent and child participated in the recall process to increase overall reliability.
Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian.
Reliability and caloric intake data are presented here.
Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes.
Caloric intake is the mean kcal per day from reliable recalls only.
|
2.5 years
|
|
Dietary Intake
Časové okno: 3 years
|
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach.
When necessary both the parent and child participated in the recall process to increase overall reliability.
Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian.
Reliability and caloric intake data are presented here.
Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes.
Caloric intake is the mean kcal per day from reliable recalls only.
|
3 years
|
|
Dietary Intake
Časové okno: 3.5 years
|
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach.
When necessary both the parent and child participated in the recall process to increase overall reliability.
Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian.
Reliability and caloric intake data are presented here.
Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes.
Caloric intake is the mean kcal per day from reliable recalls only.
|
3.5 years
|
|
Dietary Intake
Časové okno: 4 years
|
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach.
When necessary both the parent and child participated in the recall process to increase overall reliability.
Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian.
Reliability and caloric intake data are presented here.
Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes.
Caloric intake is the mean kcal per day from reliable recalls only.
|
4 years
|
|
Dietary Intake
Časové okno: 4.5 years
|
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach.
When necessary both the parent and child participated in the recall process to increase overall reliability.
Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian.
Reliability and caloric intake data are presented here.
Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes.
Caloric intake is the mean kcal per day from reliable recalls only.
|
4.5 years
|
|
Dietary Intake
Časové okno: 5 years
|
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach.
When necessary both the parent and child participated in the recall process to increase overall reliability.
Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian.
Reliability and caloric intake data are presented here.
Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes.
Caloric intake is the mean kcal per day from reliable recalls only.
|
5 years
|
|
Dietary Intake
Časové okno: 5.5 years
|
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach.
When necessary both the parent and child participated in the recall process to increase overall reliability.
Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian.
Reliability and caloric intake data are presented here.
Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes.
Caloric intake is the mean kcal per day from reliable recalls only.
|
5.5 years
|
|
Dietary Intake
Časové okno: 6 years
|
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach.
When necessary both the parent and child participated in the recall process to increase overall reliability.
Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian.
Reliability and caloric intake data are presented here.
Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes.
Caloric intake is the mean kcal per day from reliable recalls only.
|
6 years
|
|
Systolic Blood Pressure
Časové okno: 4 years
|
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
4 years
|
|
Systolic Blood Pressure
Časové okno: 4.5 years
|
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
4.5 years
|
|
Systolic Blood Pressure
Časové okno: 5 years
|
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
5 years
|
|
Systolic Blood Pressure
Časové okno: 5.5 years
|
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
5.5 years
|
|
Systolic Blood Pressure
Časové okno: 6 years
|
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
6 years
|
|
Diastolic Blood Pressure
Časové okno: 4 years
|
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
4 years
|
|
Diastolic Blood Pressure
Časové okno: 4.5 years
|
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
4.5 years
|
|
Diastolic Blood Pressure
Časové okno: 5 years
|
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
5 years
|
|
Diastolic Blood Pressure
Časové okno: 5.5 years
|
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
5.5 years
|
|
Diastolic Blood Pressure
Časové okno: 6 years
|
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
6 years
|
|
Heart Rate
Časové okno: 4 years
|
Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
4 years
|
|
Heart Rate
Časové okno: 4.5 years
|
Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
4.5 years
|
|
Heart Rate
Časové okno: 5 years
|
Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
5 years
|
|
Heart Rate
Časové okno: 5.5 years
|
Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
5.5 years
|
|
Heart Rate
Časové okno: 6 years
|
Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
6 years
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Susan E Carlson, PhD, University of Kansas Medical Center
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Colombo J, Shaddy DJ, Gustafson K, Gajewski BJ, Thodosoff JM, Kerling E, Carlson SE. The Kansas University DHA Outcomes Study (KUDOS) clinical trial: long-term behavioral follow-up of the effects of prenatal DHA supplementation. Am J Clin Nutr. 2019 May 1;109(5):1380-1392. doi: 10.1093/ajcn/nqz018.
- Kerling EH, Hilton JM, Thodosoff JM, Wick J, Colombo J, Carlson SE. Effect of Prenatal Docosahexaenoic Acid Supplementation on Blood Pressure in Children With Overweight Condition or Obesity: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2019 Feb 1;2(2):e190088. doi: 10.1001/jamanetworkopen.2019.0088.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. července 2008
Primární dokončení (Aktuální)
1. května 2016
Dokončení studie (Aktuální)
1. května 2016
Termíny zápisu do studia
První předloženo
18. června 2012
První předloženo, které splnilo kritéria kontroly kvality
30. června 2015
První zveřejněno (Odhad)
1. července 2015
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
7. února 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
29. ledna 2018
Naposledy ověřeno
1. ledna 2018
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 11406
- 1R01HD047315 (Grant/smlouva NIH USA)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .