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Lo studio clinico NCT04516252 (BW) per Sovrappeso e obesità, Adolescenti sovrappeso è attivo, non in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Enhancing BodyWorks: a Canine Health Literacy Module (BW)
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La sperimentazione clinica NCT04516252 (BW) è uno studio interventistico per Sovrappeso e obesità, Adolescenti sovrappeso, attualmente attivo, non in arruolamento. Avviato il 27 febbraio 2021, prevede di arruolare 208 partecipanti. Sotto la guida di Children's Hospital Los Angeles, dovrebbe concludersi entro il 31 dicembre 2024. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 24 ottobre 2024.
Sommario breve
Dog ownership can serve as a vehicle for large-scale multi-level public health interventions, especially for pediatric overweight and obesity, due to dogs' unique place in children and adolescents' social networks.This study develops and tests a novel approach to design a Canine Health-Literacy module to enhance a Comprehensive Family Lifestyle Intervention BodyWorks, for dog-owning adolescents who have been diagnosed with overweight or obesity, and their parents. The results are anticipated to make an important step towards addressing the overweight and obesity epidemic among both people and companion dogs in the U.S.
Descrizione dettagliata
This project is a feasibility, acceptability, and pilot study that leverages the psychosocial benefits of informed and attached dog ownership among treatment-naïve overweight or obese adolescents. It is based upon a socioecological model of health behavior that pursues multiple levels of influence, including those extending across species lines such as physical activity. BodyWorks, a Comprehensive Behavioral Family Lifestyle Interventions (CBFLI), a national, empirically validated, curriculum-based 8-week program (orientation and 7 weeks of curriculum) will be offered at Children's Hospital Los Angeles AltaMed Division of General Pediatrics, a Federally Qualified Healthcare Center. The aims of the study are: Specific Aim 1: Using current empirical evidence in veterinary medicine, to develop a Canine Health Literacy module (CHL) to be delivered as part of the existing, empirically tested BW curriculum to increase adolescents' health literacy about their dogs' physical activity needs, weight status, and nutrition. Specific Aim 2: Test the feasibility and acceptability of a concurrent approach using physical activity trackers and Ecological Momentary Assessment. 2(a): Test the feasibility and acceptability of objective measurement of physical activity using wireless fitness trackers for adolescents (FitBit Inspire), their parents (FitBit Inspire), and their dogs (FitBark); 2(b): Test the feasibility and acceptability of using mobile phones for Ecological Momentary Assessment of types and contexts of adolescent's physical activity with dogs. Specific Aim 3: To establish the size of the effect, and the variability associated with the 8 week-long BW + CHL module, as compared with the control group who received the standard BW program in 3(a) adolescents' positive affect during or after physical activity with the dog, as measured by the Ecological Momentary Assessment using prompts on mobile phones; and 3(b) levels of overall physical activity for the adolescents, their parents, and the dogs as measured by the FitBit Ace (adolescents), FitBit Flex2 (parents), and FitBark (dogs). The project will establish feasibility, acceptability, attrition, and protocol compliance, and will collect pilot data needed for power calculations in preparation for an R01 Randomized Controlled Trial as a next step to test the effectiveness of our enhanced BW+CHL program. This project represents a significant methodological and theoretical advancement in the field of Human-Animal Interaction (HAI) and in research on overweight and obesity.
Titolo ufficiale
A Health-literacy Module for Overweight Adolescents and Their Parents on Canine Physical Activity, Nutrition and Behavior: Enhancing Department of Health and Human Services' (DHHS) BodyWorks Program At a Federally Qualified Health Center
Condizioni
Sovrappeso e obesitàAdolescenti sovrappesoAltri ID dello studio
- BW
- CHLA-CG-19-00001
- R21HD097761 (Sovvenzione/Contratto NIH (USA))
Numero NCT
Data di inizio (effettiva)
2021-02-27
Ultimo aggiornamento pubblicato
2024-10-24
Data di completamento (stimata)
2024-12-31
Arruolamento (previsto)
208
Tipo di studio
Interventistico
FASE
N.D.
Stato
Attivo, non in arruolamento
Parole chiave
Overweight
Obesity
children
adolescents
comprehensive family lifestyle intervention program
telehealth
BodyWorks
Human Animal Interaction
Obesity
children
adolescents
comprehensive family lifestyle intervention program
telehealth
BodyWorks
Human Animal Interaction
Scopo principale
Altro
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleIntervention Half of the BodyWorks families will be randomized to the intervention group, and will receive a PAT for the children, the parents, and the dogs at the beginning of the cycle; the children will respond to EMA surveys using a cell phone; the children and the parents will receive the Canine health literacy module in addition to the BW curriculum. | Bodyworks Intervention BodyWorks (BW), a Comprehensive Behavioral Family Lifestyle Interventions (CBFLI), a national, empirically validated, curriculum-based 7-week program will be implemented (Borden et al., 2012; DHHS, 2013) Canine Curriculum Using our team's expertise in veterinary medicine, human-animal interaction, and animal behavior modification, develop an empirically-based, 7-week module on canine health and behavior. Valutazione ecologica momentanea Ecological Momentary Assessments (EMA) of physical activity will be conducted using mobile phones for 7 weeks of the BW program, prospectively collecting data on 4 days per week (Saturday to Tuesday) (Dunton et al., 2011; Liao et al., 2016). Physical Activity Trackers Three types of consumer-grade wireless personal activity trackers (PATs): FitBit Inspire® designed for children 8 years of age and older; FitBit Inspire® for adults (Diaz et al., 2015; Espinoza et al., 2017); and FitBark®, wireless, global positioning systems (GPS)-based personal activity trackers for dogs (Patel et al., 2017). This approach will allow us to evaluate quantity (number of steps) and intensity of physical activity in the adolescents, their parents, and their dogs, as well as to synchronize Fitbit Ace and FitBark to establish the amount of shared physical activity of adolescents and their dogs. |
Comparatore attivoControl Half of the BodyWorks participants will be randomized to the control group and will receive a PAT at the beginning of the cycle for the children, the parents, and the dogs, and the children will respond to EMA surveys using cell phones. | Bodyworks Intervention BodyWorks (BW), a Comprehensive Behavioral Family Lifestyle Interventions (CBFLI), a national, empirically validated, curriculum-based 7-week program will be implemented (Borden et al., 2012; DHHS, 2013) Valutazione ecologica momentanea Ecological Momentary Assessments (EMA) of physical activity will be conducted using mobile phones for 7 weeks of the BW program, prospectively collecting data on 4 days per week (Saturday to Tuesday) (Dunton et al., 2011; Liao et al., 2016). Physical Activity Trackers Three types of consumer-grade wireless personal activity trackers (PATs): FitBit Inspire® designed for children 8 years of age and older; FitBit Inspire® for adults (Diaz et al., 2015; Espinoza et al., 2017); and FitBark®, wireless, global positioning systems (GPS)-based personal activity trackers for dogs (Patel et al., 2017). This approach will allow us to evaluate quantity (number of steps) and intensity of physical activity in the adolescents, their parents, and their dogs, as well as to synchronize Fitbit Ace and FitBark to establish the amount of shared physical activity of adolescents and their dogs. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Physical Activity Variability associated with the BodyWorks + Canine Health Literacy intervention | Determining the mean difference between groups in the physical activity outcomes for number of steps per day as measured by the physical activity tracker | Change from baseline physical activity at 7 weeks |
Affect Variability associated with the BodyWorks + Canine Health Literacy intervention | Determining the mean difference between the groups in the positive and negative affect ecological momentary assessment outcomes. | Change from baseline affect at 7 weeks |
Feasibility of Ecological Momentary Assessment | Feasibility will be determined by data completeness: Ratio of questions answered during a wave to total number of possible questions. | Weeks 1, 4, 7 of intervention |
Acceptability of Ecological Momentary Assessment | Acceptability will be measured by EMA prompt response rate out of the total possible responses. | Week 7 of intervention |
Feasibility of use of physical activity trackers | Feasibility will be determined by data completeness: Ratio of days on which there are valid fitbit data out of the total number of days in terms of steps per day and minutes per day. | Weeks 1-7 of intervention |
Acceptability of use of physical activity trackers | Acceptability will be measured by response rate on user satisfaction survey. | Week 7 of intervention |
Physical activity for adolescents | Number of steps per day | daily for 7 weeks |
Physical activity for parents | Number of steps per day | daily for 7 weeks |
Physical activity for dogs | Number of steps per day | daily for 7 weeks |
Ecological Momentary assessments of adolescents | Mean adolescent affect ratings measured by ecological momentary assessments administered via text messages | Weeks 1, 4, 7 |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Body Mass index | Weight and height will be used to calculate BMI in kg/m\^2 | Change from baseline BMI at 7 weeks |
Criteri di eleggibilità
Età idonea
Bambino
Età minima
9 Years
Sessi idonei
Tutti
- Overweight/obese youth ages 9-17 years and their caregivers
- Own dog
- Normal BMI
- Do not own dog
Università della California Meridionale225 studi clinici attivi da esplorare
- ⚕️Tufts Medical Center
- ⚕️Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Parte responsabile dello studio
Larry Yin, Investigatore principale, Associate Professor of Clinical Pediatrics, Children's Hospital Los Angeles
Nessun dato di contatto
1 Centri dello studio in 1 paesi
California
AltaMed@CHLA, Los Angeles, California, 90057, United States