- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00200330
Modifying Obesogenic Homes: Impact on Weight Maintenance
17. april 2007 opdateret af: 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.
Studieoversigt
Status
Ukendt
Betingelser
Undersøgelsestype
Interventionel
Tilmelding
400
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02903
- Weight Control and Diabetes Research Center, The Miriam Hospital
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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 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
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
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)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Vægttab
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Sekundære resultatmål
Resultatmål |
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Fysisk aktivitet
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Diet composition
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Changes in home environment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Amy Gorin, Ph.D., The Miriam Hospital
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
- 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.
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. november 2004
Studieafslutning (Forventet)
1. april 2008
Datoer for studieregistrering
Først indsendt
13. september 2005
Først indsendt, der opfyldte QC-kriterier
13. september 2005
Først opslået (Skøn)
20. september 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. april 2007
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. april 2007
Sidst verificeret
1. september 2005
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- R01HL077082 (U.S. NIH-bevilling/kontrakt)
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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