- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00301197
Childhood Obesity Treatment: A Maintenance Approach
8 mars 2006 uppdaterad av: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Obesity is a major public health problem.
At least 15 million American adults are obese, and the number is rising.
Childhood obesity is also increasing in prevalence and currently affects approximately 11-22 percent of children aged 6 to 11. Childhood obesity is associated with serious negative physical, emotional, and social consequences.
Obese children are at high risk for becoming obese as adults; 24-44 percent of obese adults were obese as children.
The risk of an obese child becoming an obese adult is especially high when at least one parent is obese.
To date, adult obesity is known to be resistant to treatment.
In contrast, promising long-term effects have been found with children who received behavioral family-based weight loss treatment.
However, even with state-of-the-science programs, a substantial percentage of children (i.e., over 40 percent) regain all or most of the weight lost once treatment ends.
The proposed study examined the efficacy of two intervention strategies designed to improve the long-term maintenance of weight loss in children relative to discontinued treatment contact following an active weight loss treatment phase (no maintenance treatment control (NTC).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This is an efficacy study comparing two intervention strategies designed to improve the long-term maintenance of weight loss in children compared to a no maintenance treatment control group.
In this study, overweight children between the ages of 7-12 years old participated along with their overweight parents in a 20-week behavioral, family-based weight loss treatment.
Following weight loss treatment, participants were randomly assigned to one of two 4-month maintenance interventions or to a no-continued treatment control.
The Behavioral Skills Maintenance intervention (BSM) will confront the declining motivation to engage in weight-maintenance behaviors, incorporate specific skills for weight maintenance, and teach coping skills and relapse prevention techniques.
The Social Facilitation Maintenance treatment will use an innovative, socially-based approach to enhance peer support, increase parental instrumental support, improve body image, and teach effective responses to teasing as methods for sustaining weight maintenance behaviors (i.e., healthy diet and physical activity).
It is expected that children participating in BSM and SFM interventions will demonstrate better outcomes at the point of the weight maintenance intervention cessation than children not provided any maintenance treatment.
It is further hypothesized that the developmentally appropriate focus and more pervasive and sustaining nature of the SFM treatment targets relative to BSM targets will result in better weight maintenance outcomes for SFM than BSM children.
Follow-up assessments will occur at the end of the maintenance phase of treatment, as well as at 12 and 24 months following the initial weight loss treatment.
Effective maintenance treatments in children will have a substantial impact on children's immediate and future physical, psychological, and social well being.
Studietyp
Interventionell
Inskrivning
216
Fas
- Inte tillämpbar
Kontakter och platser
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Studieorter
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Missouri
-
St. Louis, Missouri, Förenta staterna, 63110
- Washington University School of Medicine
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
7 år till 12 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
Child:
- 20%-100% overweight
- 7-12 years old
At least one parent:
- At least 20% overweight
- Actively participates in program along with participating child
Both participating family members:
- Can read and speak English at a 3rd grade level
Exclusion Criteria:
Either participating child or parent:
- has current psychopathology and is not in ongoing psychiatric care
- has an active substance abuse problem
- is not taking weight-affecting medications
- does not have a medical condition for which a weight loss program would be contraindicated
- does not have a physical disability of illness that limits their ability to do physical activity
- does not have major dietary restrictions
- is not participating in an active weight loss treatment
All family members:
- do not have an active eating disorder
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
|---|
|
Weight (child and parent)
|
Sekundära resultatmått
Resultatmått |
|---|
|
Weight related behaviors
|
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Psychological functioning (specific and general)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 1999
Avslutad studie
1 april 2004
Studieregistreringsdatum
Först inskickad
8 mars 2006
Först inskickad som uppfyllde QC-kriterierna
8 mars 2006
Första postat (Uppskatta)
10 mars 2006
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
10 mars 2006
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 mars 2006
Senast verifierad
1 mars 2006
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 5R01HD036904 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .