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Pediatric Quality of Life Among Population With Body Mass Index (BMI) Greater Than or Equal to 85%

29. maj 2013 opdateret af: Steward St. Elizabeth's Medical Center of Boston, Inc.

Pediatric Quality of Life Among Population With BMI Greater Than or Equal to 85%: Impact of a Behavioral Intervention Program

We are currently experiencing an epidemic of obesity in the Pediatric Population. This epidemic affects many areas including quality of life.

We have been conducting a nutrition and exercise program since 2003. We have noticed that many of the participants seem to have a better quality of life after finishing the one year program compared to when they started. We would like to objectively quantify this improvement using a validated questionnaire at the beginning and at the end of the study. Questionnaires will be given to participants and to their caretakers at the same time. There will be two groups in the study: one intervention (minimum attendance of 4 sessions) and one control group.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

We are currently experiencing an obesity epidemic in the Pediatric population. The latest National Health and Nutrition Examination Survey (NHANES) data indicates that 16.5% has a BMI greater than or equal to 85% < 95% and 17.1% has a BMI greater than or equal to 95%. The quality of life of children who are obese has been shown to be lower than that of children with cancer. Health related quality of life measurements have emerged as an important health outcome in clinical trials, clinical practice improvement strategies, and healthcare services research and evaluation. We have conducted a behavioral nutrition and exercise program since 2003. The name of the program is Teens, Empowerment, Exercise, Education, Nutrition (TEEEN) Program. We meet once a month on a Saturday afternoon for four hours. During this time we cover: registration (monitoring of sedentary activities and liquid choices; motivational interview, exercise testing); exercise; educational interactive lectures; didactic games and projects. We have noticed that participants seem to have a better quality of life after participating in the program compared to baseline. We would like to objectively quantify this subjective finding. We will be using the Pediatric Quality of Life Inventory Version 4.0 (PedsQL(TM)4.0) questionnaire which has been validated in the pediatric population. We will have an intervention and a control group. Both participants and their caretakers will be given a questionnaire at the beginning and at the end of the study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

76

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Brighton, Massachusetts, Forenede Stater, 02135-3514
        • Steward St. Elizabeth's Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

10 år til 20 år (Barn, Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Ages 10-20
  • BMI greater or equal to 85%

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 1
intervention: this group will attend the nutrition and exercise program control group: this group will not attend the nutrition and exercise program
Adfærdsmæssigt: Behavioral nutrition and exercise program
The intervention consists of a behavioral nutrition and exercise program. Meetings occur monthly on a Saturday afternoon and last 4 hours. During this time we cover: 1)registration: monitoring of sedentary activities and liquid choices, motivational interviewing, exercise testing;2)exercise: includes strength training; 3) educational lectures; 4) didactic games and projects.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Child Self-report Health Related Quality of Life Scores After Intervention: Total, Physical and Psychosocial (Presented in This Order)
Tidsramme: one year comparing change in questionnaire scores at baseline to results from questionnaire completed a year later

Using a validated quality of life questionnaire we analyzed change in child self-report scores comparing baseline questionnaire scores to end of study questionnaire scores for these categories: total (includes physical and psychosocial), physical, and psychosocial(includes emotional, social, and school).

Scale information: The range is 0-100 in terms of points they could get for each category. They had the options of 0-4, 0 being the best. 0 would then be transformed to a score of 100, 1 to 75, 2 to 50, 3 to 25 and 4 to 0.

Results are clinically significant if the difference in scores are higher than the Minimal Clinical Important Difference (MCID). MCID are as follows: Total Score: 4.36, Physical Health: 6.66, Psychosocial Health: 5.30.
one year comparing change in questionnaire scores at baseline to results from questionnaire completed a year later

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Steward St. Elizabeth's Medical Center of Boston, Inc.

Efterforskere

  • Ledende efterforsker: Shirley Gonzalez, MD, Steward St. Elizabeth's Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2008

Primær færdiggørelse (Faktiske)

1. juli 2012

Studieafslutning (Faktiske)

1. juli 2012

Datoer for studieregistrering

Først indsendt

9. juli 2008

Først indsendt, der opfyldte QC-kriterier

11. juli 2008

Først opslået (Skøn)

14. juli 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. maj 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2013

Sidst verificeret

1. maj 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 00446

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Placeringer

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