PACE+: Counseling Adolescents for Exercise and Nutrition

Physical Activity Clinical Trial

— PACEAdol  

Official title:

PACE+: Counseling Adolescents for Exercise and Nutrition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657422
• Other study ID #: 7R01CA081495-04
• Status: Completed
• Phase: N/A
• First received: July 27, 2012
• Last updated: August 3, 2012
• Start date: August 2000
• Est. completion date: April 2006

Study information

• Verified date: August 2012
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

PACE+ was developed to address the increased number of adolescents in our country that are at risk for cardiovascular disease, cancer, and other diseases due to inactivity, obesity, and malnourishment. PACE+ will evaluate the efficacy of an integrated clinical and home-based intervention to improve physical activity and nutrition behaviors in adolescents ages 11-15 over a period of 2 years.

This study is unique in that it will be one of the first to evaluate a combined physical activity and nutrition intervention for youth that revolves around the primary health care setting. The PACE+ intervention is particularly innovative in that three components - computer, provider counseling, and an extended home-based intervention - are unified through a common theoretical framework.

Description:

Improved physical activity (PA) and nutrition behaviors in adolescents show great promise to reduce risk of cancers and other diseases. Fewer than 20% of adolescents meet recommendations for fat or fruits & vegetables consumption, and only 50% of adolescent girls and 67% of boys meet recommendations for vigorous PA. PACE+ will evaluate an integrated clinical and home-based intervention to improve physical activity (PA) and nutrition behaviors in adolescents. The intervention has three integrated components: a computer assessment and action planner; provider counseling; and 24 months of extended phone & mail contact. 768 male and female adolescents age 11 through 15; will be recruited from six healthcare settings. Subjects will be randomly assigned within practices to two successive one-year "doses" of PACE+ or a comparison condition involving counseling for sun protection behaviors. PACE+ assesses four behaviors: 1) dietary fat, 2) fruits & vegetable consumption, 3) physical activity, and 4) sedentary behavior. Primary behavioral outcomes, secondary outcomes, and selected mediators and process variables will be measured prior to the first office visit and at 6, 12 and 24 months. Primary outcomes will be measured by the 7-day physical activity recall and 3-day food record of fruits & vegetables and fat at 12 months. Secondary outcomes include adiposity, fitness, BMI, psychosocial mediators of change, and body image. Potential risks are psychological and physical, however the risks are slight and of low likelihood. Benefits include helping bring about healthier lifestyles to prevent weight gain and reduce premature morbidity and mortality due to cancer, cardiovascular disease and other health problems. This study will be the first to evaluate a combined physical activity and nutrition intervention for youth that revolves around the primary health care setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 819
• Est. completion date: April 2006
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 15 Years

Eligibility

Inclusion Criteria:

• Subjects must be in good general health and have the ability to read and speak English.

Exclusion Criteria:

• A known eating disorder,

• pregnancy,

• any cardiovascular or musculoskeletal problems that would limit their ability to comply with physical activity recommendations, and

• being in foster care (due to difficulty in obtaining follow-up measures).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dietary Modification
• Physical Activity

Intervention

Behavioral:
• PACE+
Patients assigned to the intervention group will receive intervention strategies over a the course of 2 years including: (1) completion of a 45-minute office-based computer program resulting in an assessment and action plan for improvement in physical activity and nutrition behaviors; (2) a provider counseling session immediately following the computerized assessment, followed by (3) 12 phone calls and 24 mailings over a 24-month period conducted by PACE+ staff members

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California
United States	San Diego State University Foundation	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	weight status	Both time points equally important	12 and 24 months	No
Primary	Dietary fat, fruits & vegetable consumption	Equal in importance to the other two primary outcome measures, physical activity and sedentary behaviors	12months	No
Primary	Physical activity	Equal in importance to the other two primary outcome measures, dietary fat, fruits and vegetables, and sedentary behaviors	12 months	No
Primary	sedentary behavior	equal in importance to the other two primary outcome measures: physical activity and diet fat, fruits and vegetable consumption	12 months	No
Secondary	dietary fat, fruits and vegetables	All were equal in terms of importance	24 months	No
Secondary	physical activity		24 months	No
Secondary	sedentary behavior		24 months	No