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Interventions to Control Obesity in Community Colleges (CDC WAY to Health)

21. januar 2011 opdateret af: University of North Carolina, Chapel Hill

Interventions to Control Obesity in Community Colleges

CDC WAY to Health is a three year, group-randomized weight loss intervention study where approximately 1020 overweight/obese employees nested within 17 community colleges are randomly assigned to receive one of three promising, state-of-the-art, theory-linked interventions: Environment/Usual Care (E); Web-based Weight Loss Program + Environment (WEB+E) or Web + Environment +Incentives (WEB+E+I). College is the unit of randomization and intervention; employee is the unit of analysis. Follow-up weigh-in assessments are conducted at 3, 6, and 12 months.

Studieoversigt

Detaljeret beskrivelse

Despite the fact that obesity is at epidemic proportions and costs US employers an estimated $78.5 billion annually; national data indicate that less than 25% of employers are offering disease management programs to address obesity. Effective weight loss programs that are adaptable to busy work environments and maintain employee interest are needed, but few rigorous tests of these programs have been attempted.

In collaboration with the North Carolina Community College System, NC Blue Cross Blue Shield, and the State Health Plan for Teachers and State Employees, this three year group-randomized weight loss intervention studies approximately 1020 overweight/obese employees nested within 17 community colleges. Campuses are randomly assigned to receive one of three promising, state-of-the-art, theory-linked interventions: Environment/Usual Care (E); Web-based Weight Loss Program + Environment (WEB+E) or Web + Environment +Incentives (WEB+E+I). College is the unit of randomization and intervention; employee is the unit of analysis. Follow-up weigh-in assessments are completed at 3, 6, and 12 months.

After formative research in Year 1 to adapt interventions for community college employees, the effects of these interventions are rigorously tested on 12-month weight loss (primary outcome). Most secondary outcomes (weight loss behaviors, moderate-vigorous physical activity; total calories, percent body fat, fruit/vegetable intake, absenteeism, productivity, medical expenditures, and quality of life) are assessed at baseline, 6 and 12 months; along with potential mediators/moderators of weight loss outcomes. Process tracking data measures fidelity, dose delivered/received and acceptability/satisfaction with the interventions. Extensive cost- and cost-effectiveness analysis, including return on investment, is undertaken. If proven effective, this strong partnership between community colleges, the State Health Plan, and the research team, will help guide program adoption and institutionalization/dissemination throughout the community college campus system.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1029

Fase

  • Tidlig fase 1

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • BMI greater than or equal to 25

Exclusion Criteria:

  • Type I diabetes
  • Pregnant or lactating
  • Had a recent weight loss of 20 pounds or more
  • Currently taking weight loss medication or unwilling to stop
  • Undergone or scheduled weight loss surgery
  • Experienced a malignancy requiring chemotherapy or radiation in the past five years
  • No internet access
  • Answered "yes" to the PAR-Q items and did not return a required physician's consent

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Environment / Usual Care
Andet: WEB+ Environment
Web-based weight loss program (WEB) + Environment - Participants have access to a proven Web-based weight loss program with weekly lessons focused on lifestyle behavior changes
Participants receive weekly lessons via the Web along with additional tools for weight loss support
Andre navne:
  • Web-based Weight Loss Program
Andet: WEB + Cash Incentive for Weight Loss
Web-based Weight Loss Program + Cash Incentive for Weight Loss - participants have access to a proven web-based weight loss program plus they are paid cash based on the percent weight lost at 12 months compared to baseline.
Participants receive weekly lessons via the Web along with additional tools for weight loss support
Andre navne:
  • Web-based Weight Loss Program
Participants are paid cash based on the percent weight lost at 3, 6, and 12 months.
Andre navne:
  • Web-based weight loss program + Cash incentive

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
weight change
Tidsramme: 3, 6, and 12 months
participants weight change will be analyzed at 12 months compared to baseline
3, 6, and 12 months

Sekundære resultatmål

Resultatmål
Tidsramme
moderate vigorous physical activity
Tidsramme: 3, 6, and 12 months
3, 6, and 12 months
total calories
Tidsramme: 3, 6, and 12 months
3, 6, and 12 months
percent body fat
Tidsramme: 3, 6, and 12 months
3, 6, and 12 months
fruit/veg intake
Tidsramme: 3, 6, and 12 months
3, 6, and 12 months
absenteeism
Tidsramme: 3, 6, and 12 months
3, 6, and 12 months
quality of life
Tidsramme: 3, 6, and 12 months
3, 6, and 12 months
medical expenditures
Tidsramme: 12 months
12 months

Samarbejdspartnere og efterforskere

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

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Laura A Linnan, ScD, CHES, UNC Chapel Hill

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. september 2005

Primær færdiggørelse (Faktiske)

1. november 2006

Studieafslutning (Faktiske)

1. marts 2007

Datoer for studieregistrering

Først indsendt

20. januar 2011

Først indsendt, der opfyldte QC-kriterier

21. januar 2011

Først opslået (Skøn)

25. januar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. januar 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. januar 2011

Sidst verificeret

1. januar 2011

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 04-0509
  • DP000102 (Andet bevillings-/finansieringsnummer: Centers for Disease Control)

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 .

Kliniske forsøg med WEB + Environment

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