Kansas University DHA Outcome Study (KUDOS) Follow-Up
2018. január 29. frissítette: 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.
A tanulmány áttekintése
Részletes leírás
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.
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
190
Fázis
- 3. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
-
-
Kansas
-
Kansas City, Kansas, Egyesült Államok, 66160
- University of Kansas Medical Center
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
16 év (Gyermek, Felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Női
Leírás
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
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Placebo Comparator: Placebo kapszula
|
600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
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|
Kísérleti: DHA Capsule
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600 mg DHA capsule
Más nevek:
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Adaptive Regulation Assessment
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
|
Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Anthropometrics: Weight-for-age
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Susan E Carlson, PhD, University of Kansas Medical Center
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Általános kiadványok
- 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.
Hasznos linkek
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete
2008. július 1.
Elsődleges befejezés (Tényleges)
2016. május 1.
A tanulmány befejezése (Tényleges)
2016. május 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2012. június 18.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2015. június 30.
Első közzététel (Becslés)
2015. július 1.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2018. február 7.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2018. január 29.
Utolsó ellenőrzés
2018. január 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
Egyéb vizsgálati azonosító számok
- 11406
- 1R01HD047315 (Az Egyesült Államok NIH támogatása/szerződése)
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Igen
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Nem
az Egyesült Államokban gyártott és onnan exportált termék
Nem
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .