- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01481948
Food, Fun, & Fitness Internet Program for Girls: Outcome Evaluation (FFFIPG)
18 januari 2016 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
342
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Texas
-
Houston, Texas, Verenigde Staten, 77030
- Baylor College of Medicine
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
8 jaar tot 10 jaar (Kind)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
Actieve vergelijker: 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.
|
|
Geen tussenkomst: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Body mass index percentile
Tijdsspanne: 6 months
|
height and weight will be used to calculate BMI percentile
|
6 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
fruit and vegetable consumption
Tijdsspanne: 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
Tijdsspanne: 3 months
|
Accelerometers will be used to assess physical activity at each time point
|
3 months
|
|
self efficacy
Tijdsspanne: 3 months
|
Standard measures will be used to assess fruit, vegetable, water, and physical activity self efficacy
|
3 months
|
|
home availability
Tijdsspanne: 3 months
|
standard measures will be used to assess fruit, vegetable, and physical activity equipment home availability
|
3 months
|
|
asking behaviors
Tijdsspanne: 3 months
|
standard measures will be used to assess child fruit, vegetable, water, and physical activity asking behaviors
|
3 months
|
|
fruit and vegetable consumption
Tijdsspanne: 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
Tijdsspanne: 6 months
|
Accelerometers will be used to assess physical activity
|
6 months
|
|
self efficacy
Tijdsspanne: 6 months
|
standard measures will be used to assess fruit, vegetable, water, and physical activity self efficacy
|
6 months
|
|
home availability
Tijdsspanne: 6 months
|
standard measures will be used to assess fruit, vegetable, and physical activity equipment home availability
|
6 months
|
|
asking behaviors
Tijdsspanne: 6 months
|
standard measures will be used to assess child fruit, vegetable, water, and physical activity asking behaviors
|
6 months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Deborah I Thompson, PhD, Baylor College of Medicine
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 januari 2012
Primaire voltooiing (Werkelijk)
1 mei 2015
Studie voltooiing (Werkelijk)
1 mei 2015
Studieregistratiedata
Eerst ingediend
21 november 2011
Eerst ingediend dat voldeed aan de QC-criteria
28 november 2011
Eerst geplaatst (Schatting)
30 november 2011
Updates van studierecords
Laatste update geplaatst (Schatting)
20 januari 2016
Laatste update ingediend die voldeed aan QC-criteria
18 januari 2016
Laatst geverifieerd
1 januari 2016
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- H-27505
- R01MD005814 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .