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Disseminating Effective Habits for Long-Term Weight Loss

19. oktober 2015 opdateret af: Christopher N. Sciamanna, Penn State University
The purpose of the study is to determine whether using a web-based weight loss website can help overweight individuals lose weight.

Studieoversigt

Detaljeret beskrivelse

Overweight and obesity are serious threats to public health. Over the last 20 years, the percentage of overweight and obese Americans, as well as the rate of diabetes, have grown tremendously (Cowie, Rust et al. 2006).

Few individuals are successful at long-term weight loss. Long-term weight loss is an elusive, yet sought after goal for many Americans (2000). Fewer than 5% of adults are successful in maintaining a 20 pound weight loss for at least 2 years (Klem, Wing et al. 1997). While medications can be effective, they produce only small amounts of weight loss, carry a significant cost and appear to be effective only while being taken (2000). Surgery is an effective option, though the procedure has tremendous costs and potential complications (2000). This points to the need for innovative and effective treatments that helps individuals over the longer-term.

Some, but not all, web-based treatments for weight loss have been shown to be effective. A recent study by Tate and colleagues showed that individuals who received counseling emails from a human or automated emails from a computer lost more weight than individuals who received neither(7.3 kg lost v. 4.9 kg and 2.6 kg, respectively) (Tate, Jackvony et al. 2006) (Tate, Jackvony et al. 2003). The feedback in the emails was based on diet and physical activity information that the individuals entered online. Dr. Harvey-Berino and colleagues has shown that social support delivered via the Internet can help weight loss efforts to the same degree as in person support (Harvey-Berino, Pintauro et al. 2004). Other studies have been mixed in their effects (Williamson, Walden et al. 2006) (Gold, Burke et al. 2007) (Wing, Tate et al. 2006), though there has generally been an effect from human feedback delivered via a computer. Other than the recent study by Tate and colleagues, no fully automated website has been effective at producing weight loss. It is our belief that fully automated systems are needed to meet the needs, in a cost-effective manner, of the 80 million overweight Americans who will need life-long help in losing weight and in maintaining their weight loss.

During an earlier phase of the study, 50 in-depth interviews were conducted with individuals who have been successful at losing weight and keeping it off. These individuals were asked specifically about which habits they use to maintain their weight loss, how these habits are implemented and how barriers to using these habits are overcome. These interviews were transcribed and the data entered into a website, to be used as part of the intervention to be tested in this clinical trial.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Penn State College of Medicine General Clinical Research 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

21 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age 21-65
  • BMI 27-40 kg/m2
  • Fluently speaks and reads English
  • Access to the Internet at home or at work
  • Valid email address
  • Access to a scale for weekly weigh-ins
  • Agree not to seek additional weight loss treatment
  • Agree to come back regardless of amount of weight lost
  • Participant in NCT00377208

Exclusion Criteria:

  • Current, planned, or previous pregnancy within 12 months
  • Planned or past weight loss surgery
  • Recent weight loss of >= 15 lbs in the past 6 months
  • History of:

    • Myocardial infarction
    • Stroke
    • Type 1 and Type 2 diabetes
    • Unstable angina
    • Congestive heart failure
    • Inability to exercise due to severe arthritis or other musculoskeletal problems
    • Cancer (except non-melanoma skin cancer)
  • Evidence of severe cognitive impairment or major psychiatric illness
  • Plans to move in the next 6 months
  • Answering yes to any question on the Physical Activity Readiness Questionnaire (PAR-Q)

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1

Participants in the intervention condition are encouraged to access the Achieve Together website at least once each week. During each login, the following activities will occur:

  1. Users will enter their weight and height, how well their plan for a healthy weight has been going, and clarify their goal weight.
  2. Users will answer questions about each habit they are using to lose weight
  3. Users will receive automated feedback about each habit and will be encouraged to change or delete habits that are being used but not helpful, more consistently use habits that are helpful but not used being used and to continue to use habits that are helpful and being used consistently.
  4. Users are encouraged to search for habits that have helped people of similar age and gender to themselves.
Comparison of weight change among those participants in the weight loss intervention (immediate access to the weight loss website) and those participants in the control group (delayed access to the weight loss website).
access to the Achieve Together website immediately (Arm 1) or delayed (Arm 2)
Ingen indgriben: 2
Participants in the control condition will have to wait 12 weeks before accessing the Achieve Together website. These participants will be a given a log where they can document weekly weight measurements (this part did not happen).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body weight
Tidsramme: 3 months
Weight will be measured using a calibrated, digital scale
3 months
Blood Pressure Control
Tidsramme: 3-Months
3-Months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Physical Activity, using the International Physical Activity Questionnaire
Tidsramme: 3 months
Results are still being analyzed
3 months
Block 2005 FFQ for assessment of diet and physical activity
Tidsramme: 3 Months
3 Months
IWQOL-Lite, a validated, 31-item, self-report measure of obesity-specific
Tidsramme: 3 Months
3 Months

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Christopher N Sciamanna, M.D., MPH, Penn State College of Medicine

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.

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. juli 2009

Primær færdiggørelse (Faktiske)

1. februar 2010

Studieafslutning (Faktiske)

1. december 2010

Datoer for studieregistrering

Først indsendt

1. juli 2008

Først indsendt, der opfyldte QC-kriterier

1. juli 2008

Først opslået (Skøn)

3. juli 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. oktober 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. oktober 2015

Sidst verificeret

1. oktober 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 28160

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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