- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01799759
Project Fun: Parents And Youth Together
The proposed study is a continuation of a randomized, controlled pilot effectiveness trial conducted in schools wherein the feasibility and completion of the trial by parents and children will now additionally be examined in after school and YMCA connected programs.
The intervention for this study is Project FUN and Project FUN with Parents. Project FUN is an 8 module online program for children in 4th through 8th grade. Project FUN with Parents is a 6 module online program for their parent.
Children and parents will be recruited through the afterschool and YMCA connected programs. Those agreeing to participate will be randomly assigned to a first intervention or second intervention session (waiting list control group). Surveys and measures will be collected for everyone pre-intervention, after the first session completion and after the second session completion to create a waiting list control group.
Hypothesis 1: Body composition and dietary fat of children who complete Project FUN and have a parent complete Project FUN with Parents will be lower on completion than children who only complete instruments.
Hypothesis 2: Fruit and vegetable intake, physical activity and fitness of children who complete Project FUN and have a parent complete Project FUN with Parents will be greater on completion than children who only complete instruments.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Addressing the epidemic of obesity is a national priority. Currently almost a third of children and two thirds of adults are overweight or obese. Obesity-related chronic health problems originating in childhood are often life-long. Overweight and obesity result from detrimental patterns of dietary intake and physical activity. These obesity-producing lifestyles are established in childhood and are often carried into adulthood, when they become more refractory to change. Research has demonstrated that programs involving parents and children in a family context have been the most effective in preventing and treating childhood obesity.
Research Question 1: How many parents and children agree to participate, complete data collection and complete at least 80% of the intervention? Research Question 2: What reasons are given by those not completing the protocol and what suggestions are offered by those who do complete the protocol? Research Question 3: What is the relationship of parent or child perceptions of authoritative parenting, child perceptions of family models and support for healthy eating, physical activity, or reduced sedentary time, and of parenting stress, self-efficacy, confidence, and eating behavior on child BMI? Research Question 4: Do parent or child perceptions of authoritative parenting, diet, physical activity, fitness or body composition; child perceptions of family models and support for healthy eating, physical activity, or reduced sedentary time; or parent perceptions of parenting stress, self-efficacy, confidence, and eating behavior change across the study time period? Research Question 5: Are there relationships between study completion and child or parent BMI, child or parent gender, parenting stress, self-efficacy, confidence, and eating behavior?
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Wisconsin
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Milwaukee, Wisconsin, Stati Uniti, 53233
- Marquette University College of Nursing
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Children in 4th through 8th grade and a parent(s)who can read and write English. Must be able to come to Marquette University or Milwaukee area YMCA for pre and post test data collection and to complete online modules.
Exclusion Criteria:
- None
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Online intervention for parent and child
Children complete 8 online modules of Project FUN Parents complete 6 modules of Project FUN for Parents
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Child online intervention is 8 modules based on the Health Promotion/Transtheoretical Model Parent online intervention is 6 modules based on enhancing authoritative parenting,support and role models for improved nutrition, physical activity and health child body mass percentile
|
|
Altro: Instruments only
The waiting list control group only completes instruments and body composition, fitness measures
|
Parent and child subejects in the waiting list control only complete surveys, body composition and fitness tests
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
child body mass percentile
Lasso di tempo: 6-12 weeks
|
Child height and weight are measured and the body mass percentile calculated using the Centers for Disease Control and Prevention algorithm for adjustment by age and gender.
|
6-12 weeks
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Marilyn Frenn, PhD, RN, Marquette University College of Nursing
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HR-1625
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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