NCT01657422

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
819

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 6, 2012

Completed
Last Updated

August 6, 2012

Status Verified

August 1, 2012

Enrollment Period

4.3 years

First QC Date

July 27, 2012

Last Update Submit

August 3, 2012

Conditions

Dietary ModificationPhysical Activity

Keywords

NutritionPhysical ActivityAdolescents

Outcome Measures

Primary Outcomes (3)

  • Dietary fat, fruits & vegetable consumption

    Equal in importance to the other two primary outcome measures, physical activity and sedentary behaviors

    12months

  • Physical activity

    Equal in importance to the other two primary outcome measures, dietary fat, fruits and vegetables, and sedentary behaviors

    12 months

  • sedentary behavior

    equal in importance to the other two primary outcome measures: physical activity and diet fat, fruits and vegetable consumption

    12 months

Secondary Outcomes (3)

  • dietary fat, fruits and vegetables

    24 months

  • physical activity

    24 months

  • sedentary behavior

    24 months

Other Outcomes (1)

  • weight status

    12 and 24 months

Study Arms (2)

PACE+ Intervention

EXPERIMENTAL

Intervention Group

Behavioral: PACE+

Sun Protection

NO INTERVENTION

Control / Comparison group. Patients assigned to the comparison group will receive intervention strategies over a the course of 2 years including: (1) completion of a 30-minute office-based computer program resulting in on-screen feedback to address excess sun exposure prevention, and (2) 4 phone calls and 4 mailings over a 24-month period conducted by PACE+ staff members.

Interventions

PACE+BEHAVIORAL

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

Also known as: PACE+ Intervention
PACE+ Intervention

Eligibility Criteria

Age11 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, San Diego

La Jolla, California, 92093, United States

Location

San Diego State University Foundation

San Diego, California, 92128, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Kevin Patrick, MD

    UCSD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kevin Patrick, MD, MS, Principal Investigaor and Professor

Study Record Dates

First Submitted

July 27, 2012

First Posted

August 6, 2012

Study Start

August 1, 2000

Primary Completion

November 1, 2004

Study Completion

April 1, 2006

Last Updated

August 6, 2012

Record last verified: 2012-08

Locations

US(2)