Effects of Lifestyle Intervention on Childhood Outcomes in LGA Infants
2. februar 2021 opdateret af: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Childhood Health Outcomes in Term, Large-for-gestational-age Infants: Effects of Lifestyle Intervention in the Postnatal First Year
Large-for-gestational-age (LGA) infants have a higher risk of metabolic disease later in life, and their postnatal growth in early childhood may be associated with long-term adverse outcomes.
The purpose of this study is to explore whether comprehensive lifestyle intervention in the first year after birth in LGA infants will reduce the rate of overweight/obesity at childhood and improve neurodevelopmental outcomes and its possible mechanism.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Term LGA infants will be randomly divided into two groups shortly after birth: intervention group and control group.
Infants in intervention group will attend the follow-up clinic and motor development assessment and guidance will be provided every three months in the first year.
Other lifestyle interventions include feeding guidance and healthcare education.
Infants in control group will routinely attend the follow-up clinic every six months.
Primary outcome is the rate of overweight/obesity at two years old and seven years old.
Neurodevelopmental assessment, carotid intima-media thickness (CIMT) and blood pressure at childhood will also be evaluated.
The association of the outcome of LGA infants at two years old and the biomarkers in cord blood will be investigated, which includes serum leptin, insulin, insulin-like growth factors -1 (IGF-1), blood lipid series and adiponectin.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
138
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Shanghai
-
Shanghai, Shanghai, Kina, 2000892
- Rekruttering
- Xinhua Hospital
-
Kontakt:
- Hongping Xia, Dr
- Telefonnummer: 8392 86-21-25078999
- E-mail: xiahongping@xinhuamed.com.cn
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 dag til 1 måned (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- term
- large-for-gestational-age infants
Exclusion Criteria:
- major genetic disorder
- congenital anomalies
- severe digestive disease
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Lifestyle Intervention
every 3 months within 1 year.
|
Feeding guidance: promoting exclusive breastfeeding and healthy diet (Pediatrician).
Motor development assessment and guidance: Alberta Infant movement scale (AIMS) evaluation, guidance for motor development (Rehabilitation Therapist).
Healthcare education: improvement of environmental exposure (Pediatrician).
|
|
Ingen indgriben: control group
Regular follow-up every 6 months within 1 year.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of overweight/obesity at 2 years old
Tidsramme: at 2 years old
|
Weight and height will be combined to report BMI in kg/m^2.
According to the intergrowth-21st age-specific BMI standard issued in 2014, BMI ≥ 85th percentile is defined as overweight; BMI ≥ 95th percentile is defined as obesity
|
at 2 years old
|
|
Rate of overweight/obesity at 7 years old
Tidsramme: at 7 years old
|
Weight and height will be combined to report BMI in kg/m^2.
According to the intergrowth-21st age-specific BMI standard issued in 2014, BMI ≥ 85th percentile is defined as overweight; BMI ≥ 95th percentile is defined as obesity
|
at 7 years old
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Neurodevelopmental assessment at 2 years old
Tidsramme: at 2 years old
|
Bayley III's assessment of infants is divided into five areas: cognition, language, body movement, social emotion and adaptive behavior.
|
at 2 years old
|
|
Carotid intima-media thickness (CIMT) at 2 years old
Tidsramme: at 2 years old
|
Carotid intima-media thickness (CIMT) will be measured by experienced Pediatric Cardiologist.
|
at 2 years old
|
|
Association of BMI at 2 years old with biomarkers in cord blood
Tidsramme: at 2 years old
|
Biomarkers include: serum leptin, insulin, IGF - Ⅰ, blood lipid series, adiponectin
|
at 2 years old
|
|
Association of BMI at 7 years old with biomarkers in cord blood
Tidsramme: at 7 years old
|
Biomarkers include: serum leptin, insulin, IGF - Ⅰ, blood lipid series, adiponectin
|
at 7 years old
|
|
Blood pressure at 7 years old
Tidsramme: at 7 years old
|
Blood pressure will be measured by experienced nurses.
|
at 7 years old
|
|
Carotid intima-media thickness (CIMT) at 7 years old
Tidsramme: at 7 years old
|
Carotid intima-media thickness (CIMT) will be measured by experienced Pediatric Cardiologist.
|
at 7 years old
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
22. januar 2021
Primær færdiggørelse (Forventet)
30. november 2023
Studieafslutning (Forventet)
30. november 2029
Datoer for studieregistrering
Først indsendt
1. november 2020
Først indsendt, der opfyldte QC-kriterier
8. december 2020
Først opslået (Faktiske)
10. december 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. februar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. februar 2021
Sidst verificeret
1. december 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- XH-20-023
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