Familial Overweight: Comparing Use of Strategies (FOCUS)
19 maggio 2015 aggiornato da: Brian Saelens, Seattle Children's Hospital
Behavioral Skill Adherence in Pediatric Obesity Treatment
The purpose of this study is to compare the efficacy of two different approaches (prescribed & self-directed) to the treatment of childhood obesity and their relative impact on child weight status, physical activity, and diet.
Panoramica dello studio
Descrizione dettagliata
Pediatric obesity is a highly prevalent problem, requiring both treatment and prevention efforts to reduce cardiovascular disease risk and metabolic consequences among affected children and the child population.
The efficacy of family-based behavioral pediatric obesity treatment is likely compromised by non-optimal parent and child behavioral skills use (BSU).
In pediatric obesity treatment trials, BSU assessment is infrequent, incomplete, and has unknown reliability.
Poor and incomplete BSU measurement precludes improving behavioral interventions for pediatric obesity.
Furthermore, different approaches to help families initiate and sustain BSU during and following treatment have not been tested.
This study aims to investigate 1) prospective relations between BSU measured during and following treatment and change in child weight status, physical activity, and diet, and 2) differences in BSU trajectory between two different implementation approaches during and following treatment.
Eighty-two parent-child (7-11 y.o.) pairs will participate in a 20-week treatment with follow-up at 3 and 6 months.
Participants will be randomly assigned to receive either a prescriptive or self-directed implementation approach to family-based behavioral pediatric obesity treatment.
BSU (monitoring, contingency management, environmental control) will be reported or assessed at pre-treatment, at the 5th, 10th, and 15th treatment sessions, at post-treatment and at the 3-month and 6-month follow-ups by the parent, interventionist, and supplemental evaluator.
Prospective associations between BSU, measured multiple times and by multiple informant/formats, and change in child weight status (z-BMI) and weight-related behaviors (diet, physical activity) over the course of treatment and throughout follow up will be examined.
This proposal will provide important information about the type of BSU and its measurement that is most related to short- and long-term treatment efficacy, and provide pilot data on the relative efficacy of different implementation approaches to initiate and sustain BSU in pediatric obesity intervention.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
72
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Washington
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Seattle, Washington, Stati Uniti, 98101
- Seattle Children's Hospital Research Institute
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 7 anni a 11 anni (Bambino)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Child age: 7-11 years.
- English-speaking.
- Parent is willing and able to actively participate in treatment.
- Overweight child: at or above 85th percentile for age- and gender-specific BMI, but not more than 175% above median BMI for age and gender.
- Overweight parent: BMI≥ 25.
- Live within 50 miles of Children's Hospital and Regional Medical Center.
Exclusion Criteria:
- Medical condition known to promote obesity (e.g. Prader-Willi syndrome, Cushing's syndrome).
- Already involved with another weight control program.
- Consistently engaging in weight-affecting behaviors (e.g. child: smoking)
- Significant diagnosed obesity-related co-morbidities (e.g. Type 2 diabetes)
- Taking weight-affecting medications (e.g. Ritalin)
- Participating parent or child: an existing thought disorder, suicidality, substance abuse disorder, or other psychological or medical conditions that may preclude full participation.
- Participating parent or child: Disability or illness that would preclude them from engaging in at least moderate intensity physical activity.
- Participating parent or child: Current or prior diagnosed eating disturbance.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: Prescribed Skills
Behavioral skills are all prescribed and considered necessary tools expected to be used consistently, completely, and uniformly by all participants throughout treatment
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Treatment will be delivered over a 20-week period.
Participating children and at least one of their parents will attend weekly in-person clinic sessions.
Treatment will consist of 20-25 minute meetings between the assigned interventionist and each child/parent pair to individualize treatment, with an emphasis on helping the family change eating and activity behaviors.
Family meetings will be followed by separate child and parent group meetings lasting approximately 35-45 minutes.
In both approaches, parents serve as primary implementers of the treatment for the child and, if overweight, for themselves.
Group sessions provide education in diet and physical activity, parenting, and behavioral skills, although conditions differ in whether skills are "prescribed" or "self-directed".
Children and parents will be weighed at each clinic visit.
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Sperimentale: Self-Directed Skills
Behavioral skills are considered a tool box from which families are encouraged to select skills that best apply to that family's situation in attempts to help their child make eating and activity change.
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Treatment will be delivered over a 20-week period.
Participating children and at least one of their parents will attend weekly in-person clinic sessions.
Treatment will consist of 20-25 minute meetings between the assigned interventionist and each child/parent pair to individualize treatment, with an emphasis on helping the family change eating and activity behaviors.
Family meetings will be followed by separate child and parent group meetings lasting approximately 35-45 minutes.
In both approaches, parents serve as primary implementers of the treatment for the child and, if overweight, for themselves.
Group sessions provide education in diet and physical activity, parenting, and behavioral skills, although conditions differ in whether skills are "prescribed" or "self-directed".
Children and parents will be weighed at each clinic visit.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Child weight status, physical activity, & diet.
Lasso di tempo: 6 Months
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6 Months
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Secondary outcomes will include parents' BMI, and parents' physical activity and eating behaviors and covariates will include child age, gender, and household income.
Lasso di tempo: 6 Months
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6 Months
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Brian E Saelens, PhD, Seattle Children's Hospital Research Institute
Pubblicazioni e link utili
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 maggio 2008
Completamento primario (Effettivo)
1 dicembre 2012
Completamento dello studio (Effettivo)
1 dicembre 2012
Date di iscrizione allo studio
Primo inviato
3 settembre 2008
Primo inviato che soddisfa i criteri di controllo qualità
3 settembre 2008
Primo Inserito (Stima)
4 settembre 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
21 maggio 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
19 maggio 2015
Ultimo verificato
1 maggio 2015
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HD54871 (completed)
- 1R21DK095676 (Sovvenzione/contratto NIH degli Stati Uniti)
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 .