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PACE+: Counseling Adolescents for Exercise and Nutrition

PACE+: Counseling Adolescents for Exercise and Nutrition

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01657422
Acronym
PACEAdol
Enrollment
819
Registered
2012-08-06
Start date
2000-08-31
Completion date
2006-04-30
Last updated
2012-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Modification, Physical Activity

Keywords

Nutrition, Physical Activity, Adolescents

Brief 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.

Detailed 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.

Interventions

BEHAVIORALPACE+

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

Sponsors

San Diego State University
CollaboratorOTHER
University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to 15 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
sedentary behavior12 monthsequal in importance to the other two primary outcome measures: physical activity and diet fat, fruits and vegetable consumption
Dietary fat, fruits & vegetable consumption12monthsEqual in importance to the other two primary outcome measures, physical activity and sedentary behaviors
Physical activity12 monthsEqual in importance to the other two primary outcome measures, dietary fat, fruits and vegetables, and sedentary behaviors

Secondary

MeasureTime frameDescription
sedentary behavior24 months
dietary fat, fruits and vegetables24 monthsAll were equal in terms of importance
physical activity24 months

Other

MeasureTime frameDescription
weight status12 and 24 monthsBoth time points equally important

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026