- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01481948
Food, Fun, & Fitness Internet Program for Girls: Outcome Evaluation (FFFIPG)
18. Januar 2016 aktualisiert von: Deborah Thompson, Baylor College of Medicine
Using Technology to Prevent Obesity Among African American Girls
The purpose of this project is to reduce health disparities in obesity risk among 8-10 year old African American girls using a culturally sensitive and developmentally appropriate internet-based program with no face-to-face interaction.
This study will conduct an outcome evaluation to test short and longer term effects on obesity risk.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This research will conduct an outcome evaluation on a promising web based obesity prevention program for 8-10 year old African American girls.
A pilot study with 80 girls established its feasibility: recruitment goals were met; attrition rates were < 10%; logon rates to the online program were 74.5%; and statistically significant increases in fruit and vegetable consumption and time spent being physically active were observed.
The outcome evaluation will recruit 400 child-parent pairs to examine short and longer term effects of the program on obesity risk.
It will also conduct mediation analyses to examine pathways of effect.
At the end of the study, the web based program will be hosted on the CNRC web site.
Although the use of the internet as a method for changing health behavior is not new, the use of an internet program alone, with no face to face interaction, is novel.
This is one of the first programs to attempt this, particularly in an at-risk population.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
342
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Texas
-
Houston, Texas, Vereinigte Staaten, 77030
- Baylor College of Medicine
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
8 Jahre bis 10 Jahre (Kind)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Weiblich
Beschreibung
Inclusion Criteria:
- 8-10 years old
- healthy
- African American
- parent willing to participate in data collection
- internet access
- personal email address
Exclusion Criteria:
- mental, physical, or medical conditions that limit fruit-vegetable consumption, physical activity, or ability to fully participate in the program and/or complete baseline and post assessment data collection
- taking medications that influence dietary behaviors, appetite, and/or physical activity
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: story plus behaviorial procedures
The girls randomized to this arm of the study will view an interactive story about 6 8-10 year old African American girls who seek to find clues to solve a mystery about the town in which they live.
The episodes will contain information about healthy nutrition and physical activity, as well as basic information about physical activity and kitchen safety tips, developmentally appropriate recipes, and portion sizes.
Girls randomized to this arm of the study will also engage in key behavior change procedures, such as goal setting, problem solving, and self monitoring.
|
This is an 8 episode intervention, delivered entirely over the internet.
Each episode, girls will view an interactive story in which 6 8-10 year old African American characters attempt to solve a mystery about their town.
The online program will include information about healthy nutrition (i.e., consuming more fruit, vegetables, water) and physical activity.
There will be two groups; one group (the experimental group) will view the interactive story and participate in key behavior change procedures, such as personal goal setting, problem solving, and self monitoring activities.
The second group (the active comparator group) will view the online stories but will not engage in key behavior change procedures.
|
Aktiver Komparator: story only
The girls randomized to this arm of the study will view an interactive story about 6 8-10 year old African American girls who seek to find clues to solve a mystery about the town in which they live.
The episodes will contain information about healthy nutrition and physical activity, as well as basic information about physical activity and kitchen safety tips, developmentally appropriate recipes, and portion sizes.
Girls randomized to this arm of the study will not engage in key behavior change procedures, such as goal setting, problem solving, and self monitoring.
|
This is an 8 episode intervention, delivered entirely over the internet.
Each episode, girls will view an interactive story in which 6 8-10 year old African American characters attempt to solve a mystery about their town.
The online program will include information about healthy nutrition (i.e., consuming more fruit, vegetables, water) and physical activity.
There will be two groups; one group (the experimental group) will view the interactive story and participate in key behavior change procedures, such as personal goal setting, problem solving, and self monitoring activities.
The second group (the active comparator group) will view the online stories but will not engage in key behavior change procedures.
|
Kein Eingriff: Wait list control
This group will participate in data collection only; after the 3rd data collection point, they will be given access to the intervention
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Body mass index percentile
Zeitfenster: 6 months
|
height and weight will be used to calculate BMI percentile
|
6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
fruit and vegetable consumption
Zeitfenster: 3 months
|
dietitian-assisted dietary recalls will be collected using the NDSR system; 2 recalls will be collected (1 week day and 1 weekend day)
|
3 months
|
physical activity
Zeitfenster: 3 months
|
Accelerometers will be used to assess physical activity at each time point
|
3 months
|
self efficacy
Zeitfenster: 3 months
|
Standard measures will be used to assess fruit, vegetable, water, and physical activity self efficacy
|
3 months
|
home availability
Zeitfenster: 3 months
|
standard measures will be used to assess fruit, vegetable, and physical activity equipment home availability
|
3 months
|
asking behaviors
Zeitfenster: 3 months
|
standard measures will be used to assess child fruit, vegetable, water, and physical activity asking behaviors
|
3 months
|
fruit and vegetable consumption
Zeitfenster: 6 months
|
dietitian-assisted dietary recalls will be collected using the NDSR system; 2 recalls will be collected at each time point (1 week day and 1 weekend day)
|
6 months
|
physical activity
Zeitfenster: 6 months
|
Accelerometers will be used to assess physical activity
|
6 months
|
self efficacy
Zeitfenster: 6 months
|
standard measures will be used to assess fruit, vegetable, water, and physical activity self efficacy
|
6 months
|
home availability
Zeitfenster: 6 months
|
standard measures will be used to assess fruit, vegetable, and physical activity equipment home availability
|
6 months
|
asking behaviors
Zeitfenster: 6 months
|
standard measures will be used to assess child fruit, vegetable, water, and physical activity asking behaviors
|
6 months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Deborah I Thompson, PhD, Baylor College of Medicine
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Callender C, Liu Y, Moore CE, Thompson D. The baseline characteristics of parents and African American girls in an online obesity prevention program: A feasibility study. Prev Med Rep. 2017 May 19;7:110-115. doi: 10.1016/j.pmedr.2017.05.011. eCollection 2017 Sep.
- Thompson D, Mahabir R, Bhatt R, Boutte C, Cantu D, Vazquez I, Callender C, Cullen K, Baranowski T, Liu Y, Walker C, Buday R. Butterfly Girls; promoting healthy diet and physical activity to young African American girls online: rationale and design. BMC Public Health. 2013 Aug 2;13:709. doi: 10.1186/1471-2458-13-709.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Januar 2012
Primärer Abschluss (Tatsächlich)
1. Mai 2015
Studienabschluss (Tatsächlich)
1. Mai 2015
Studienanmeldedaten
Zuerst eingereicht
21. November 2011
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
28. November 2011
Zuerst gepostet (Schätzen)
30. November 2011
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
20. Januar 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
18. Januar 2016
Zuletzt verifiziert
1. Januar 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- H-27505
- R01MD005814 (US NIH Stipendium/Vertrag)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .