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Modifying Obesogenic Homes: Impact on Weight Maintenance

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ClinicalTrials.gov Identifier: NCT00200330
Recruitment Status : Unknown
Verified September 2005 by The Miriam Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : April 18, 2007
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
The Miriam Hospital

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date April 18, 2007
Study Start Date  ICMJE November 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Weight loss
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Diet composition
  • Physical activity
  • Changes in home environment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modifying Obesogenic Homes: Impact on Weight Maintenance
Official Title  ICMJE Not Provided
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Behavioral: Behavioral weight loss treatment
  • Behavioral: Behavioral and home environment weight loss treatment
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: September 13, 2005)
400
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00200330
Other Study ID Numbers  ICMJE R01HL077082( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE The Miriam Hospital
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Amy Gorin, Ph.D. The Miriam Hospital
PRS Account The Miriam Hospital
Verification Date September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP