- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00063674
Type 2 Diabetes Primary Prevention for At Risk Girls
Purpose: To evaluate two approaches to prevent obesity and type 2 diabetes in young girls.
The Need: We are experiencing an epidemic of childhood obesity. Rates of obesity have doubled to tripled in the past two decades, with the highest rates among poor and ethnic minority girls. Type 2 diabetes (what used to be called adult-onset diabetes) is now showing up in overweight children, and more children are manifesting precursors of heart disease and stroke.
Our Two Approaches:
- A state-of-the-art nutrition education program with monthly newsletters mailed to girls and their parents and quarterly evening lectures/educational events at school sites, including cooking demonstrations and games to improve nutrition and increase physical activity.
- After-school dance classes held five days per week all year long at school sites from the time school lets out until 6PM. Dance classes will include a 1-1.5 hour supervised homework study hall each day, and emphasize both traditional ethnic dances and popular dance.
Participants: Second, third and fourth grade girls and their families will be eligible to participate. All activities are free of charge. To be able to perform a valid evaluation, to be able to accommodate all girls at their own school, and to be fair about which girls receive which program, families who wish to participate will be randomly selected to participate in either one program or the other (nutrition education or dance classes). Each family will participate for two years.
Evaluation: Trained Stanford staff will perform all evaluation procedures with participating families in their own homes at the beginning and every six months. Families will be compensated for their participation.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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-
California
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Palo Alto, California, Vereinigte Staaten, 94304
- Stanford University School of Medicine
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Beschreibung
Second-, third- and fourth-grade girls, aged 7-10 years of age enrolled in one of the participating schools will be eligible. Our goal is to be as inclusive as possible. However, girls will not be eligible to participate if they:
- have been diagnosed with a chronic illness that affects their growth and/or weight (e.g., type 1 diabetes, hypothyroidism, inflammatory bowel disease)
- are taking medications potentially affecting their growth and/or weight (e.g., methylphenidate HCl, systemic steroids)
- have Asthma (not exclusionary alone) but have taken systemic steroids (oral, intravenous, or intramuscular) for a period of more than 21 days in the past year
- have a condition that limits their participation in physical activity enough that they are not able to participate in Physical Education at school (e.g., significant structural heart disease)
- are pregnant
- are unable to complete the informed consent process.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Nutrition Education
A state-of-the-art nutrition education program with monthly newsletters mailed to girls and their parents and quarterly evening lectures/educational events at school sites, including cooking demonstrations and games to improve nutrition and increase physical activity.
|
|
|
Experimental: After-school dance class
After-school dance classes held five days per week all year long at school sites from the time school lets out until 6PM.
Dance classes will include a 1-1.5 hour supervised homework study hall each day, and emphasize both traditional ethnic dances and popular dance.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Body Mass Index (BMI)
Zeitfenster: 24 months
|
Change in body mass index (BMI) over the 2-year intervention period.
BMI was calculated as weight in kilograms divided by height in meters squared.
|
24 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Waist Circumference
Zeitfenster: 24 months
|
Change in waist circumference measured in centimeters over the 24-month intervention period.
|
24 months
|
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Change in Total Cholesterol
Zeitfenster: 24 months
|
Change in fasting serum total cholesterol level over the 24-month intervention period.
|
24 months
|
|
Change in LDL Cholesterol Level
Zeitfenster: 24 months
|
Change in fasting low-density lipoprotein (LDL) cholesterol level over the 24-month intervention period.
|
24 months
|
|
Change in HDL Cholesterol Level
Zeitfenster: 24 months
|
Change in fasting high-density lipoprotein (HDL) cholesterol level over the 24-month intervention period.
|
24 months
|
|
Change in Fasting Glucose
Zeitfenster: 24 months
|
Change in fasting serum glucose level over the 24-month intervention period.
|
24 months
|
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Change in Fasting Insulin
Zeitfenster: 24 months
|
Change in fasting serum insulin level over the 24-month intervention period.
|
24 months
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Thomas N Robinson, MD, MPH, Stanford University
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Geschätzt)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des endokrinen Systems
- Ernährungsstörungen
- Stoffwechselerkrankungen
- Überernährung
- Körpergewicht
- Störungen des Glukosestoffwechsels
- Übergewicht
- Hyperglykämie
- Pathologische Zustände, Anzeichen und Symptome
- Verhalten
- Ernährungs- und Stoffwechselerkrankungen
- Anzeichen und Symptome
- Therapietreue und Compliance
- Gesundheitsverhalten
- Zuverlässigkeit des Patienten
- Patientenakzeptanz der Gesundheitsversorgung
- Adhärenzinterventionen
- Medikamentenhaftung
- Fettleibigkeit
- Diabetes Mellitus
- Glukose Intoleranz
- Motorik
- Gesundheitserziehung
- Qualität, Zugang und Bewertung im Gesundheitswesen
- Untersuchungstechniken
- Epidemiologische Methoden
- Datenerfassung
- Gesundheitsbewertungsmechanismen
- Qualität der Gesundheitsversorgung
- Öffentliche Gesundheit
- Umwelt und öffentliche Gesundheit
- Epidemiologische Messungen
- Ernährungsbewertung
Andere Studien-ID-Nummern
- T2DPPG (completed)
- R01DK062360 (US NIH Stipendium/Vertrag)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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