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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00986011
Other study ID # LAC-USC-HS-0700681
Secondary ID CDR0000655182
Status Completed
Phase N/A
First received September 26, 2009
Last updated July 9, 2013
Start date April 2008
Est. completion date February 2013

Study information

Verified date September 2009
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Observational

Clinical Trial Summary

RATIONALE: Overweight and obesity have been associated with multiple types of disease, including cancer. Living in a smart growth community may encourage behaviors that would reduce the risk of obesity.

PURPOSE: This research study is looking at the effect of a smart growth community on prevention of obesity in middle-, moderately low- and low-income families.


Description:

OBJECTIVES:

Primary

- To evaluate the effects of the whole set as well as individual smart growth principles on prevention of obesity risk in middle, moderately low, and low-income families who reside in a smart growth community, the Preserve, compared to two types of control groups of families who reside in other communities that may naturally vary in exposure to these principles.

- To evaluate the longitudinal-mediational relationship between increased activity and pro-health attitudes achieved in the smart growth community to lower obesity risk.

- To identify trajectories of physical activity over time and evaluate their relationship to obesity risk, including high-stable, early-onset stable, early-onset short-term, and low-stable trajectories.

Secondary (exploratory)

- To evaluate demographic x type of community (smart growth vs other) interactions (with the major ethnic groups representing Hispanic vs white), gender, parent vs child on outcomes, as well as on obesogenic trajectories.

- To evaluate a possible "chaining" or translational effect, i.e., whether effects of living in a smart growth community generalize to changes in eating behavior as part of a general change in health attitudes.

- To assess whether neighborhoods where physical activity actually takes place (defined as 0.5 square-mile area and 10-15 walking distance from residence, school [for children], work or equivalent [for index adult], and leisure), contribute significantly to physical activity and eating behavior beyond the effect of smart growth community residence.

- To determine whether some individual smart growth principles may have a relatively greater impact on obesity risk than others, in both intervention and control communities.

- To assess whether physical activity trajectories other than those hypothesized can be identified for their predictive relationship to obesity prevention.

OUTLINE: Participants receive an accelerometer monitor and are instructed to wear it for 7 continuous days (except when sleeping, bathing, or swimming) on the right hip attached to an adjusted belt to assess physical activity. Participants also undergo anthropometric measures (height and weight) using a calibrated digital scale and professional stadiometer.

Participants complete surveys and questionnaires on Self-reported Physical Activity, Self-reported Dietary Intake, and Social Network Survey. Participants also complete other self-reported items assessing demographic characteristics, family finances, health status, health history, length of current residence, home-relocation patterns, time use and transportation patterns, substance use, depression, sleeping habits, fast-food consumption, and school and work addresses.

PROJECTED ACCRUAL: A total of 390 families living in The Preserve, 195 families who were not chosen to live in The Preserve, and 195 control families who live in the surrounding area will be accrued for this study.


Recruitment information / eligibility

Status Completed
Enrollment 780
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility DISEASE CHARACTERISTICS:

- Must meet 1 of the following criteria:

- Residents who live in The Preserve, a smart growth community in Chino, California

- Chosen by lottery to live in The Preserve

- Prospective buyers and renters for residences in The Preserve (but were not chosen to live in The Preserve) living in the following communities and/or cities:

- Ontario

- Pomona

- Diamond Bar

- Corona

- Yorba Linda/Mira Loma

- Chino

- Families from Chino and surrounding communities within a 30-minute drive from The Preserve

- Families with children in grades 4-8 must meet the following criteria:

- Each family unit consists of 1 index parent defined as the parent who spends relatively more time in the neighborhood on a daily basis

- An index child defined as a 4th-8th-grade child

- Income levels range from very-low income to middle income ($20-$165,000) based on Area Median Income

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Study Design

N/A


Intervention

Other:
questionnaire administration

study of socioeconomic and demographic variables

survey administration

Procedure:
study of high risk factors


Locations

Country Name City State
United States USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
University of Southern California National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Levels of physical activity and pro-healthy lifestyle attitudes No
Primary Body-mass index No
Primary Trajectories of physical activity and the relationship to obesity risk No
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