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ObesityPathwaysNCT00787709

Translational Obesity Research

A study testing Pathways in people with Obesity, run by University of Southern California at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The proposed project takes an innovative approach to childhood obesity prevention, for which there currently no evidence-based programs, and for which results of current trials have produced mainly short-term or disappointing effects. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Pathways
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,005 participants
Where
1 siteUnited States
Study dates
May 2007to 28 Feb 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 4th grade students at participating schools

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Southern California

    Alhambra, California, 91803

Other trials in United States

About this study

Official title: Translational Research: Applying Drug Prevention to Obesity Prevention

The proposed project takes an innovative approach to childhood obesity prevention, for which there currently no evidence-based programs, and for which results of current trials have produced mainly short-term or disappointing effects. The aim of this project is to adapt and revise parts of two nationally recognized programs for drug prevention for use with children in grades 4-6 with the express purpose of obesity prevention. The current study will attempt to promote emotion regulation, neuro-cognitive function, and social competence in order to prevent obesity. A total of 24 elementary schools from two of the largest districts in Orange County will be randomly assigned to either the obesity prevention program or control group (N=1587) 4th grade students and their parents). A cohort of students will be followed from the 4th through 6th grades. Intervention students will be administered the Pathways obesity prevention program by trained teachers. The population is ethnically diverse (36% white, 57% Hispanic, 6%Asian; 48% on free/reduced lunch programs). Self-report measures, BMI, and waist circumference will be administered at the beginning of 4th grade, and at end of 4th , 5th , and 6th grade. Teacher, administrative, and parent surveys will be administered on the same schedule to measure school environment. Program implementation will be measured by teacher self-report and research staff observations. Data will be analyzed with statistical approaches that capture effects of school and classroom, test the theoretical model of change, and evaluate developmental trends in mediators and outcomes across the three grades. Findings should be generalizable to most elementary schools, and will be used to develop evidence-based program standards for childhood obesity prevention.

Conditions
Obesity
Being tested
Pathways
Keywords
Obesity prevention, Health promotion, School based curriculum
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PathwaysBehavioural

    3-year, 30 lesson, School-based universal health promotion curriculum with parent component.

Study groups in NCT00787709
Study groupRoleWhat they receive
1ExperimentalReceives Pathways universal school-based health promotion curriculum from 4th-6th grade
Receives: Behavioral: Pathways
2No interventionControl group of students who do not receive the intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Food Intake

    Measured: 9 month posttest, 21 month follow-up, 33 month follow-up

  2. Physical Activity

    Measured: baseline, 9 month posttest, 21 month posttest, 33 month posttest

  3. Body Mass Index

    Measured: baseline, 9 month posttest, 21 month posttest, 33 month posttest

Secondary outcomes (3)

  1. Executive Cognitive Function

    Measured: baseline, 9 month posttest, 21 month posttest, 33 month posttest

  2. Stress

    Measured: baseline, 9 month posttest, 21 month posttest, 33 month posttest

  3. Attitudes toward healthy eating and physical activity

    Measured: baseline, 9 month posttest, 21 month posttest, 33 month posttest

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2008 (estimated)
  2. Study startMay 2007
  3. Primary completionApr 2011
  4. Study completion28 Feb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,005 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00787709
Sponsor's protocol ID
HS-08-00437
Other IDs
R01HD052107
Acronym
Pathways
Status last verified
Mar 2017
First submitted
6 Nov 2008
Last updated
27 Mar 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Cappelli C, Pike JR, Christodoulou G, Riggs NR, Warren CM, Pentz MA. The effect of sensation seeking on alcohol use among middle school students: a latent state-trait analysis. Am J Drug Alcohol Abuse. 2020 May 3;46(3):316-324. doi: 10.1080/00952990.2019.1660885. Epub 2019 Sep 11.

    PubMed 31509018

  • Cappelli C, Pike JR, Riggs NR, Warren CM, Pentz MA. Executive function and probabilities of engaging in long-term sedentary and high calorie/low nutrition eating behaviors in early adolescence. Soc Sci Med. 2019 Sep;237:112483. doi: 10.1016/j.socscimed.2019.112483. Epub 2019 Aug 7.

    PubMed 31404882

  • Warren C, Riggs N, Pentz MA. Executive function mediates prospective relationships between sleep duration and sedentary behavior in children. Prev Med. 2016 Oct;91:82-88. doi: 10.1016/j.ypmed.2016.07.024. Epub 2016 Jul 29.

    PubMed 27477059

  • Little MA, Riggs NR, Shin HS, Tate EB, Pentz MA. The effects of teacher fidelity of implementation of pathways to health on student outcomes. Eval Health Prof. 2015 Mar;38(1):21-41. doi: 10.1177/0163278713489879. Epub 2013 Jun 4.

    PubMed 23739725

  • Pentz MA, Riggs NR. Longitudinal relationships of executive cognitive function and parent influence to child substance use and physical activity. Prev Sci. 2013 Jun;14(3):229-37. doi: 10.1007/s11121-012-0312-3.

    PubMed 23345012

  • Pentz MA, Spruijt-Metz D, Chou CP, Riggs NR. High calorie, low nutrient food/beverage intake and video gaming in children as potential signals for addictive behavior. Int J Environ Res Public Health. 2011 Dec;8(12):4406-24. doi: 10.3390/ijerph8124406. Epub 2011 Nov 29.

    PubMed 22408581

Questions about this trial

What is this clinical trial studying?

A study testing Pathways in people with Obesity, run by University of Southern California at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Food Intake (time frame: 9 month posttest, 21 month follow-up, 33 month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00787709, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.

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