Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00853814
Other study ID # R01HD055270
Secondary ID 5R01HD055270-025
Status Recruiting
Phase N/A
First received February 26, 2009
Last updated February 27, 2009
Start date September 2007
Est. completion date September 2011

Study information

Verified date February 2009
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact James N Roemmich, Ph.D.
Phone 716-829-3400
Email roemmich@buffalo.edu
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

Increased access to highly reinforcing sedentary behaviors in the home such as TV and computers are associated with overweight in youth. Reducing these behaviors reduces overweight and prevents increases in overweight in youth who are at risk, likely by increasing physical activity and/or reducing energy intake. Reducing access to highly reinforcing sedentary activities frees-up time and youth must choose to reallocate their time between engaging in other, less reinforcing sedentary activities or physical activity. Neighborhood environments that provide easy access to reinforcing physical activities such as those at parks may result in greater increases in physical activity when access to highly reinforcing home sedentary behaviors is reduced. The investigators have found in 3 data sets of youth ranging in age from 4 to 16 years that the proportion of park and recreation area to residential area within ½ mile of the child's home parcel (park and recreation index) independently predicted the physical activity of youth. The investigators also found that increases in physical activity when access to sedentary behaviors were reduced for 3 weeks was related to park area within ½ mile of the child's home. The aim of this study is to decrease access to home sedentary behaviors for 4 months and determine if changes in physical activity habits are related to access to parks and recreation areas in the neighborhood environment. The investigators propose to study 128 sedentary overweight male and female 12-14 year-old youth recruited from parcels within Erie County, New York that have a high or low park and recreation index. Groups will be matched on racial/ethnic distribution and socioeconomic status. Subjects living at low and high park access parcels will then be equally randomized to groups that reduce targeted sedentary behavior (TV, computer use) time by 50% using TV Allowance devices placed on each TV/monitor in the home or a control group that has the same experimental experiences including TV Allowance devices placed on each TV/monitor, but programmed to not limit access to targeted sedentary behavior. Subjects will wear both accelerometers and wrist-watch-type global positioning systems to determine changes in the duration and intensity of physical activity in various parcel types, including parks. The investigators hypothesize differential responses in physical activity and the utilization of parks for physical activity. The group of youth that live at parcels with high access to parks and that incur a 50% reduction in sedentary behavior will have greater increases in physical activity, number of visits to parks and will accrue greater physical activity at parks than youth in the other 3 treatment groups. The investigators hypothesize that the alterations in physical activity will be mediated by parent modeling of physical activity and individual differences in the motivation to be physically active. The investigators hypothesize that there will be a main effect of reduction in access to sedentary behaviors on energy and fat intake and percent overweight.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 2011
Est. primary completion date September 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Years to 16 Years
Eligibility Inclusion Criteria:

- Parent and child must wear an accelerometer and record their sedentary behaviors

- Youth must engage in at least 24 h/week of time in sedentary behaviors

- Youth should have no dietary or activity restrictions

- Youth and parents should have no psychopathology that would limit participation

- No contraindications to physical activity in either the parent or adolescent

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Access to sedentary behaviors
Access to sedentary behaviors: Reduced access - reduce access to sedentary behaviors by 50% using TV Allowance technology. Usual access - monitoring only, no change in access to sedentary behaviors. Access to neighborhood parks: High access - large amount of park land very near to the child's home. Low access - little to no park land near the child's home.

Locations

Country Name City State
United States University at Buffalo Buffalo New York

Sponsors (1)

Lead Sponsor Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical activity 10 weeks No
Secondary Physical activity in parks 10 weeks No
Secondary Dietary intake 10 weeks No
Secondary BMI percentile 10 weeks No
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2