- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00200330
Modifying Obesogenic Homes: Impact on Weight Maintenance
17. april 2007 oppdatert av: The Miriam Hospital
The obesity epidemic observed in recent years can be largely attributed to an obesogenic environment that encourages overeating and sedentary lifestyles.
Behavioral weight control treatment, the most empirically validated intervention approach, produces initial weight losses of 10%; however, maintenance of initial weight loss and behavior change has not been achieved.
These disappointing long-term results may reflect the fact that participants are given only minimal, indirect instruction on how to change their environment to support their new weight-regulating behaviors.
While in theory, the behavioral model emphasizes environmental antecedents and consequences of eating and exercise, in practice, only 1 to 2 sessions in standard treatment are dedicated to stimulus control-types of skills.
By teaching weight control skills in a contextual vacuum, participants remain vulnerable to the same environmental influences that maintained their unhealthy eating and exercise habits.
Given that the majority of eating and exercise is home-based, a logical step in strengthening behavioral treatment and moving toward an ecological model of behavior is to expand the focus of treatment from the individual to the individual plus their home environment.
We propose to test the long-term impact of a behavioral weight control program designed to directly modify both the physical and social home environment of weight loss participants.
Two hundred overweight and obese men and women will be randomly assigned to either 18 months of standard behavioral treatment (SBT) or 18 months of standard behavioral treatment plus direct modifications to the home environment (SBT+Home).
SBT+Home will incorporate many strategies that have shown promise in improving weight loss (e.g., food and exercise equipment provision, spouse involvement) but will be the first to study both physical and social factors within the home simultaneously and will be the longest examination of the home environment conducted to date.
Participants and spouses will be assessed at baseline, 6, 12, and 18 months.
We hypothesize that by broadening the focus of treatment from the individual to the individual plus their home environment, SBT+Home will produce both better long-term weight loss and better maintenance of initial weight loss and behavior change.
This home environmental approach, if successful, has potential applications to the maintenance of other important health behaviors.
Studieoversikt
Status
Ukjent
Forhold
Studietype
Intervensjonell
Registrering
400
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Rhode Island
-
Providence, Rhode Island, Forente stater, 02903
- Weight Control and Diabetes Research Center, The Miriam Hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- are between 21-70 years of age.
- have a body mass index (BMI) between 25-50 kg/m2 .
- live with another overweight adult who is between 18-70 years of age and has a BMI between 25-50 kg/m2 and who is willing to participate in the study
Exclusion Criteria:
- report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q; items 1-4). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
- report conditions that in the judgment of the Principal Investigator would render them potentially unlikely to follow the protocol for 18 months including an illness likely to be terminal within 18 months, plans to move out of the area, substance abuse or other significant psychiatric problems, or dementia.
- report being unable to walk 2 blocks (1/4 mile) without stopping.
- are currently participating in a weight loss program and/or taking a weight loss medication.
- are currently pregnant or intend to become pregnant in the next 18 months.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
|---|
|
Vekttap
|
Sekundære resultatmål
Resultatmål |
|---|
|
Fysisk aktivitet
|
|
Diet composition
|
|
Changes in home environment
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Amy Gorin, Ph.D., The Miriam Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Cornelius T, Gettens K, Gorin AA. Dyadic Dynamics in a Randomized Weight Loss Intervention. Ann Behav Med. 2016 Aug;50(4):506-15. doi: 10.1007/s12160-016-9778-8.
- Gorin AA, Powers TA, Koestner R, Wing RR, Raynor HA. Autonomy support, self-regulation, and weight loss. Health Psychol. 2014 Apr;33(4):332-9. doi: 10.1037/a0032586. Epub 2013 Jun 3.
- Gorin AA, Raynor HA, Fava J, Maguire K, Robichaud E, Trautvetter J, Crane M, Wing RR. Randomized controlled trial of a comprehensive home environment-focused weight-loss program for adults. Health Psychol. 2013 Feb;32(2):128-37. doi: 10.1037/a0026959. Epub 2012 Feb 6.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2004
Studiet fullført (Forventet)
1. april 2008
Datoer for studieregistrering
Først innsendt
13. september 2005
Først innsendt som oppfylte QC-kriteriene
13. september 2005
Først lagt ut (Anslag)
20. september 2005
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
18. april 2007
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. april 2007
Sist bekreftet
1. september 2005
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- R01HL077082 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .