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Community-based Program to Treat Childhood Obesity

21. juni 2021 opdateret af: UnitedHealth Group

Effects of a Community-based Program to Treat Childhood and Adolescent Obesity

This study will evaluate the effectiveness of a comprehensive community based program on reducing excess weight in children and teens. This study will recruit 150 participants between the ages of 6-12 and 13-17.

Studieoversigt

Status

Afsluttet

Betingelser

Fedme hos børn

Intervention / Behandling

Adfærdsmæssigt: JOIN Intervention

Detaljeret beskrivelse

This study will evaluate the effectiveness of a comprehensive community based program on reducing excess weight. Overweight and obese study participants will be grouped with peers of similar ages and their parent/guardians. The participants will be divided into 2 groups, child (6-12 yrs. old) and teens (13-17 yrs. old) and will be accompanied by their parent/guardian. 150 participants will be recruited for this study.

This 6-month program (12 in-person group workshop sessions and 12 at-home sessions) takes the best components of current evidence for individual treatment and places them in a comprehensive community based program. These include:

Parental involvement
Reduction in consumption of sugar sweetened beverages
Reduction of screen time
Self-monitoring
Physical activity
Stimulus control

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

155

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
- Rhode Island
  - Providence, Rhode Island, Forenede Stater, 02903
    - YMCA of Greater Providence

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

6 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

Children and teens between the ages of 6-17
BMI percentile ≥85
Participation of a parent/guardian

Exclusion Criteria:

Enrollment in another weight loss program or study
Diagnosis of type 1 or type 2 diabetes
Pre-existing medical conditions (e.g., Prader Willi) that affect weight and appetite
Medications (e.g., steroids) that affect weight or appetite
Serious or unstable medical or psychological conditions that, in the opinion of the Principal Investigator, would compromise the participant's safety or successful participation in the study

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: Enkelt gruppeopgave
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Change in weight and body mass index (BMI) in children and teens at 6 months Tidsramme: 6 Months	Assess the effects of a community based program on weight change in children ages 6-12 and teens ages 13-17. Assessments will occur at baseline, 3 and 6 months.	6 Months

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Change in weight and BMI in parent/guardian/care giver at 6 months Tidsramme: 6 months	Assess the effects of a community based program on weight change in parent/guardian/care givers. Assessments will occur at baseline, 3 and 6 months.	6 months
Change in physical activity level in children and teens at 6 months Tidsramme: 6 months	Assess the effects of a community based program on physical activity level. Accelerometers will be used to access change at baseline, 3 and 6 months.	6 months
Changes in intake and sedentary behavior at 6 months Tidsramme: 6 months	Change in the number of sugar sweetened beverages consumed per day, hours per day on screen time (TV, video games, and computer), and quality of life at 6 months. Assessments will occur at baseline, 3 and 6 months.	6 months
Process Outcomes Tidsramme: 6 Months	Assess process outcomes measures, such as attendance and program satisfaction.	6 Months

Samarbejdspartnere og efterforskere

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

Sponsor

UnitedHealth Group

Efterforskere

Ledende efterforsker: Deneen Votja, MD, UnitedHealth Group

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 (Faktiske)

1. januar 2011

Primær færdiggørelse (Faktiske)

5. juni 2012

Studieafslutning (Faktiske)

5. juni 2012

Datoer for studieregistrering

Først indsendt

14. juni 2011

Først indsendt, der opfyldte QC-kriterier