Modifying Obesogenic Homes: Impact on Weight Maintenance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by The Miriam Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT00200330
First received: September 13, 2005
Last updated: April 17, 2007
Last verified: September 2005
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Behavioral weight loss treatment
Behavioral: Behavioral and home environment weight loss treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Weight loss

Secondary Outcome Measures:
  • Diet composition
  • Physical activity
  • Changes in home environment

Estimated Enrollment: 400
Study Start Date: November 2004
Estimated Study Completion Date: April 2008
  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00200330

Locations
United States, Rhode Island
Weight Control and Diabetes Research Center, The Miriam Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
Investigators
Principal Investigator: Amy Gorin, Ph.D. The Miriam Hospital
  More Information

Additional Information:
No publications provided by The Miriam Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00200330     History of Changes
Other Study ID Numbers: R01-HL77082
Study First Received: September 13, 2005
Last Updated: April 17, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by The Miriam Hospital:
weight loss
physical activity
diet
home environment

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014