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Delivering an Evidence-Based Lifestyle Intervention Via the Internet: A Randomized Controlled Study

13. januar 2016 opdateret af: Kathleen McTigue, University of Pittsburgh

Hershey Medical Center and the University of Pittsburgh are doing a research study to help meet the needs of the adult population at risk for diabetes and heart disease. This study will provide a web-based program that aims to help participants to develop healthier eating habits, lose weight and become more physically active. The Internet-based materials will teach participants about healthy eating and physical activity and will ask them to incorporate the information they learn into their daily lives.

The purpose of this study is to evaluate the effectiveness of online lifestyle change programs to promote weight loss, healthy eating and physical activity patterns, in the interest of reducing risk for and adverse outcomes of type 2 diabetes (T2D) and cardiovascular disease (CVD).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

120

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Penn State Milton S. Hershey 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

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Please note: Only individuals who receive primary care at one of the Internal Medicine clinics at Milton S. Hershey Medical Center in Hershey, PA, are eligible for this study.

Inclusion Criteria:

  • Age between 18 and 80 years old
  • Obese based on World Health Organization criteria (BMI>30kg/m2)
  • Receiving primary care from and referred by a provider at one of the Internal Medicine clinics at Milton S. Hershey Medical Center in Hershey, PA
  • Able to understand and sign an informed consent document
  • Able to communicate with the investigator and understand the requirements of this study

Exclusion Criteria

  • Primary care provider determines that the individual is unable to safely undertake moderately intense unsupervised physical activity (the equivalent of 30 minutes of brisk walking)
  • Primary care provider determines that the individual has inadequate cognitive function to participate in either active intervention curricula
  • Women who are pregnant, who are planning to become pregnant in the next two years, or who become pregnant during the study
  • Women who are breastfeeding
  • Prisoners
  • Children
  • Individuals who are planning to have bariatric surgery or who have had bariatric surgery in the past two years
  • Individuals with uncontrolled hypertension (systolic blood pressure (SBP) >165, diastolic blood pressure (DBP) >100)
  • Individuals with an edematous state that interferes with body weight assessment (e.g., severe congestive heart failure, end- stage renal disease, or ascites),
  • Individuals already using weight loss therapy
  • Individuals with an inability to learn adequately from English language audio-taped materials
  • Individuals with a lack of high-speed Internet access (Internet access will be based on participant perception; for example, participants could use computers belonging to friends, relatives, or libraries if they feel that they can access them regularly)
  • Individuals without access to a scale
  • Individuals unable to attend an Orientation session at Hershey Medical Center in Hershey, PA

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: More-Intensive
Adfærdsmæssigt: More-Intensive
The online lifestyle intervention will include elements of a behavioral lifestyle program developed by the Diabetes Prevention Program. The program will assist individual participants with establishing appropriate weight loss goals, implementing dietary recommendations (including analysis of current diet), and defining exercise programs. The program curriculum provides standard information about healthy lifestyle, and behavioral techniques for integrating them into daily living. In each lesson, patients provide feedback about how they interpret the information, and ideas for integrating it into their lives.
Aktiv komparator: Less-Intensive
Adfærdsmæssigt: Less-Intensive
The participants will be provided with the information to access the online Diabetes Prevention Program (DPP) intervention materials. Following the original DPP trial, all DPP materials were placed online for the public to access. This group will receive a lifestyle counseling session and tools to facilitate their intervention.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change in body weight (kg)
Tidsramme: 6 months, 12 months, 18 months
6 months, 12 months, 18 months

Sekundære resultatmål

Resultatmål
Tidsramme
Percentage of body weight lost
Tidsramme: 6 months, 12 months, 18 months
6 months, 12 months, 18 months
Change in blood pressure (mm Hg)
Tidsramme: 6 months, 12 months, 18 months
6 months, 12 months, 18 months
Change in health-related quality of life as determined by the RAND-36 PCS or MCS
Tidsramme: 6 months, 12 months, 18 months
6 months, 12 months, 18 months
Change in physical activity (steps per day)
Tidsramme: 6 months, 12 months, 18 months
6 months, 12 months, 18 months
Change in dietary pattern
Tidsramme: 6 months, 12 months, 18 months
6 months, 12 months, 18 months
Satisfaction with program
Tidsramme: 6 months, 12 months, 18 months
6 months, 12 months, 18 months

Samarbejdspartnere og efterforskere

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

Sponsor

University of Pittsburgh

Samarbejdspartnere

United States Department of Defense
Milton S. Hershey Medical Center

Efterforskere

  • Ledende efterforsker: Kathleen McTigue, MD MS MPH, University of Pittsburgh

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. marts 2010

Primær færdiggørelse (Faktiske)

1. januar 2012

Studieafslutning (Faktiske)

1. december 2012

Datoer for studieregistrering

Først indsendt

5. januar 2010

Først indsendt, der opfyldte QC-kriterier

5. januar 2010

Først opslået (Skøn)

7. januar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. januar 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HMC32877

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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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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