Cardiovascular DiseasesPhase 2NCT00000545
PATHWAYS--FULL SCALE STUDY
A Phase 2 study testing exercise and diet in people with Cardiovascular Diseases and Sedentary Behaviors, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To implement a culturally appropriate school-based, multicenter, randomized trial that promotes healthful eating behaviors and increases physical activity to prevent obesity in pre-adolescent upper elementary American Indian students. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Cardiovascular Diseases, Sedentary Behaviors, Obesity
- What is being tested?
- exercise and diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1993to Jul 2002
- Phase
- Phase 2
- 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Cohort of pre-adolescent American Indian boys and girls followed in grades 3-5.
About this study
To implement a culturally appropriate school-based, multicenter, randomized trial that promotes healthful eating behaviors and increases physical activity to prevent obesity in pre-adolescent upper elementary American Indian students.
Read the detailed description
BACKGROUND:
The American Indian population, including American Indians and Alaska Natives, totals nearly 1.5 million from over 500 tribes and nearly 300 reservations and Alaska Native villages. Earlier in this century, heart disease was rarely noted in American Indians, but in the past decade, cardiovascular disease has become the leading cause of death in American Indians. Several factors may be responsible for this increase: a decreasing incidence of infectious disease, an increasing incidence of diabetes mellitus, and an increasing incidence of obesity. Previous research on non-Indian populations indicates that obesity is an independent risk factor for cardiovascular disease and that it is associated with increases in other cardiovascular disease risk factors such as high blood pressure, diabetes, and low high density lipoprotein cholesterol levels. The high prevalence of obesity among American Indians, coupled with its role as a risk factor for hypertension, coronary heart disease, and diabetes, suggests that a reduction in the average weight of young American Indians would improve their health. Reduction of the prevalence of obesity in American Indians has been designated as a goal for improving the health of this minority population and reducing health disparities in our nation.
The successful 4-1/2 year feasibility study was followed by the full-scale randomized trial involving 1,700 American Indian elementary schoolchildren. Schools were the unit of randomization.
The initiative was developed as a result of consultations with the NHLBI Ad Hoc Committee on Minority Populations, the Conference on Obesity and Cardiovascular Disease in Minority Populations, and the Indian Health Service. The need for the study was reinforced by the preliminary data from the Strong Heart Study confirming the high prevalence of obesity in American Indians. The initiative was approved by the Clinical Applications and Prevention Advisory Committee in February 1992 and given concept clearance by the National Heart, Lung, and Blood Advisory Council in May 1992.
DESIGN NARRATIVE:
The Feasibility Phase of the trial was completed in 1995. The organizational structure has been established, validation studies to determine an endpoint and formative assessment of the tribe communities was completed. Intervention including classroom curriculum, food service, physical activity family component and for the measurement methods including obesity, physical activity, diet intake, knowledge, attitudes and behavior, and process evaluation were completed.
The full-scale trial started in September 1996. The primary aim was to test the effectivenes of a culturally appropriate school-based intervention that promoted increased physical activity and healthful eating behaviors to prevent obesity in American Indian upper elementary school children. The primary outcome was percent body fat after three years of intervention. The major hypothesis was that intervention would result in an absolute difference of 3 percent body fat between the control and intervention schools. All students enrolled in the second grade in the participating schools during Spring, 1997 participated in the baseline survey. Baseline measurements were performed at the end of second grade so that the intervention could begin at the start of third grade. The intervention lasted for three years. A single cohort of children progressed through third, fourth, and fifth grades. Schools were the unit of randomization. Forty-one schools in four centers were stratified within each field center on median percent body fat (PBF) at the end of second grade using data from the baseline measurement. Schools within a field center were then ranked on median PBF. Once stratified, the coordinating center randomly assigned half the schools within each stratum to intervention (21) and half to control (20).
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Sedentary Behaviors, Obesity
- Being tested
- exercise, diet
- Medical subject headings
- Cardiovascular Diseases, Sedentary Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
dietBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startSep 1993
- Study completionJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Prevention
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- H. Stevens, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000545
- Sponsor's protocol ID
- 88
- Other IDs
- U01HL050869, U01HL050907, U01HL050905, U01HL050885
- Status last verified
- Dec 2005
- First submitted
- 27 Oct 1999
- Last updated
- 29 Jul 2016
- Results posted
- No
Publications
Prevention of obesity in American Indian children: the Pathways study. Am J Clin Nutr. 1999 Apr;69(4 Suppl):745S-824S. doi: 10.1093/ajcn/69.4.745S. No abstract available.
PubMed 10195596Caballero B: Introduction. Am J Clin Nutr, 69: 745S-746S, 1999.
Story M, Evans M, Fabsitz RR, Clay TE, Holy Rock B, Broussard B. The epidemic of obesity in American Indian communities and the need for childhood obesity-prevention programs. Am J Clin Nutr. 1999 Apr;69(4 Suppl):747S-754S. doi: 10.1093/ajcn/69.4.747S.
PubMed 10195597Davis CE, Hunsberger S, Murray DM, Fabsitz RR, Himes JH, Stephenson LK, Caballero B, Skipper B. Design and statistical analysis for the Pathways study. Am J Clin Nutr. 1999 Apr;69(4 Suppl):760S-763S. doi: 10.1093/ajcn/69.4.760S.
PubMed 10195599Lohman TG, Caballero B, Himes JH, Hunsberger S, Reid R, Stewart D, Skipper B. Body composition assessment in American Indian children. Am J Clin Nutr. 1999 Apr;69(4 Suppl):764S-766S. doi: 10.1093/ajcn/69.4.764S.
PubMed 10195600Gittelsohn J, Evans M, Story M, Davis SM, Metcalfe L, Helitzer DL, Clay TE. Multisite formative assessment for the Pathways study to prevent obesity in American Indian schoolchildren. Am J Clin Nutr. 1999 Apr;69(4 Suppl):767S-772S. doi: 10.1093/ajcn/69.4.767S.
PubMed 10195601Stevens J, Cornell CE, Story M, French SA, Levin S, Becenti A, Gittelsohn J, Going SB, Reid R. Development of a questionnaire to assess knowledge, attitudes, and behaviors in American Indian children. Am J Clin Nutr. 1999 Apr;69(4 Suppl):773S-781S. doi: 10.1093/ajcn/69.4.773S.
PubMed 10195602Weber JL, Cunningham-Sabo L, Skipper B, Lytle L, Stevens J, Gittelsohn J, Anliker J, Heller K, Pablo JL. Portion-size estimation training in second- and third-grade American Indian children. Am J Clin Nutr. 1999 Apr;69(4 Suppl):782S-787S. doi: 10.1093/ajcn/69.4.782S.
PubMed 10195603Going SB, Levin S, Harrell J, Stewart D, Kushi L, Cornell CE, Hunsberger S, Corbin C, Sallis J. Physical activity assessment in American Indian schoolchildren in the Pathways study. Am J Clin Nutr. 1999 Apr;69(4 Suppl):788S-795S. doi: 10.1093/ajcn/69.4.788S.
PubMed 10195604Davis SM, Going SB, Helitzer DL, Teufel NI, Snyder P, Gittelsohn J, Metcalfe L, Arviso V, Evans M, Smyth M, Brice R, Altaha J. Pathways: a culturally appropriate obesity-prevention program for American Indian schoolchildren. Am J Clin Nutr. 1999 Apr;69(4 Suppl):796S-802S. doi: 10.1093/ajcn/69.4.796S.
PubMed 10195605Snyder P, Anliker J, Cunningham-Sabo L, Dixon LB, Altaha J, Chamberlain A, Davis S, Evans M, Hurley J, Weber JL. The Pathways study: a model for lowering the fat in school meals. Am J Clin Nutr. 1999 Apr;69(4 Suppl):810S-815S. doi: 10.1093/ajcn/69.4.810S.
PubMed 10195607Helitzer DL, Davis SM, Gittelsohn J, Going SB, Murray DM, Snyder P, Steckler AB. Process evaluation in a multisite, primary obesity-prevention trial in American Indian schoolchildren. Am J Clin Nutr. 1999 Apr;69(4 Suppl):816S-824S. doi: 10.1093/ajcn/69.4.816S.
PubMed 10195608Stevens J, Story M, Becenti A, French SA, Gittelsohn J, Going SB, Juhaeri, Levin S, Murray DM. Weight-related attitudes and behaviors in fourth grade American Indian children. Obes Res. 1999 Jan;7(1):34-42. doi: 10.1002/j.1550-8528.1999.tb00388.x.
PubMed 10023728Gittelsohn J, Evans M, Helitzer D, Anliker J, Story M, Metcalfe L, Davis S, Iron Cloud P. Formative research in a school-based obesity prevention program for Native American school children (Pathways). Health Educ Res. 1998 Jun;13(2):251-65. doi: 10.1093/her/13.2.251.
PubMed 10181023Koehler KM, Cunningham-Sabo L, Lambert LC, McCalman R, Skipper BJ, Davis SM. Assessing food selection in a health promotion program: validation of a brief instrument for American Indian children in the southwest United States. J Am Diet Assoc. 2000 Feb;100(2):205-11. doi: 10.1016/S0002-8223(00)00064-X.
PubMed 10670393
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PATHWAYS--FULL SCALE STUDY
- ClinicalTrials.gov ID
- NCT00000545
- Acronym / sponsor ID
- 88
- Conditions
- Cardiovascular Diseases, Sedentary Behaviors, Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1993
- Study completion
- Jul 2002 (actual)
- First posted
- 28 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To implement a culturally appropriate school-based, multicenter, randomized trial that promotes healthful eating behaviors and increases physical activity to prevent obesity in pre-adolescent upper elementary American Indian students.
Detailed description
BACKGROUND:
The American Indian population, including American Indians and Alaska Natives, totals nearly 1.5 million from over 500 tribes and nearly 300 reservations and Alaska Native villages. Earlier in this century, heart disease was rarely noted in American Indians, but in the past decade, cardiovascular disease has become the leading cause of death in American Indians. Several factors may be responsible for this increase: a decreasing incidence of infectious disease, an increasing incidence of diabetes mellitus, and an increasing incidence of obesity. Previous research on non-Indian populations indicates that obesity is an independent risk factor for cardiovascular disease and that it is associated with increases in other cardiovascular disease risk factors such as high blood pressure, diabetes, and low high density lipoprotein cholesterol levels. The high prevalence of obesity among American Indians, coupled with its role as a risk factor for hypertension, coronary heart disease, and diabetes, suggests that a reduction in the average weight of young American Indians would improve their health. Reduction of the prevalence of obesity in American Indians has been designated as a goal for improving the health of this minority population and reducing health disparities in our nation.
The successful 4-1/2 year feasibility study was followed by the full-scale randomized trial involving 1,700 American Indian elementary schoolchildren. Schools were the unit of randomization.
The initiative was developed as a result of consultations with the NHLBI Ad Hoc Committee on Minority Populations, the Conference on Obesity and Cardiovascular Disease in Minority Populations, and the Indian Health Service. The need for the study was reinforced by the preliminary data from the Strong Heart Study confirming the high prevalence of obesity in American Indians. The initiative was approved by the Clinical Applications and Prevention Advisory Committee in February 1992 and given concept clearance by the National Heart, Lung, and Blood Advisory Council in May 1992.
DESIGN NARRATIVE:
The Feasibility Phase of the trial was completed in 1995. The organizational structure has been established, validation studies to determine an endpoint and formative assessment of the tribe communities was completed. Intervention including classroom curriculum, food service, physical activity family component and for the measurement methods including obesity, physical activity, diet intake, knowledge, attitudes and behavior, and process evaluation were completed.
The full-scale trial started in September 1996. The primary aim was to test the effectivenes of a culturally appropriate school-based intervention that promoted increased physical activity and healthful eating behaviors to prevent obesity in American Indian upper elementary school children. The primary outcome was percent body fat after three years of intervention. The major hypothesis was that intervention would result in an absolute difference of 3 percent body fat between the control and intervention schools. All students enrolled in the second grade in the participating schools during Spring, 1997 participated in the baseline survey. Baseline measurements were performed at the end of second grade so that the intervention could begin at the start of third grade. The intervention lasted for three years. A single cohort of children progressed through third, fourth, and fifth grades. Schools were the unit of randomization. Forty-one schools in four centers were stratified within each field center on median percent body fat (PBF) at the end of second grade using data from the baseline measurement. Schools within a field center were then ranked on median PBF. Once stratified, the coordinating center randomly assigned half the schools within each stratum to intervention (21) and half to control (20).
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
- Primary purpose
- Prevention
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise | Behavioural | – |
| diet | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Background: PubMed 10195596Prevention of obesity in American Indian children: the Pathways study. Am J Clin Nutr. 1999 Apr;69(4 Suppl):745S-824S. doi: 10.1093/ajcn/69.4.745S. No abstract available.
- BackgroundCaballero B: Introduction. Am J Clin Nutr, 69: 745S-746S, 1999.
- Background: PubMed 10195597Story M, Evans M, Fabsitz RR, Clay TE, Holy Rock B, Broussard B. The epidemic of obesity in American Indian communities and the need for childhood obesity-prevention programs. Am J Clin Nutr. 1999 Apr;69(4 Suppl):747S-754S. doi: 10.1093/ajcn/69.4.747S.
- Background: PubMed 10195599Davis CE, Hunsberger S, Murray DM, Fabsitz RR, Himes JH, Stephenson LK, Caballero B, Skipper B. Design and statistical analysis for the Pathways study. Am J Clin Nutr. 1999 Apr;69(4 Suppl):760S-763S. doi: 10.1093/ajcn/69.4.760S.
- Background: PubMed 10195600Lohman TG, Caballero B, Himes JH, Hunsberger S, Reid R, Stewart D, Skipper B. Body composition assessment in American Indian children. Am J Clin Nutr. 1999 Apr;69(4 Suppl):764S-766S. doi: 10.1093/ajcn/69.4.764S.
- Background: PubMed 10195601Gittelsohn J, Evans M, Story M, Davis SM, Metcalfe L, Helitzer DL, Clay TE. Multisite formative assessment for the Pathways study to prevent obesity in American Indian schoolchildren. Am J Clin Nutr. 1999 Apr;69(4 Suppl):767S-772S. doi: 10.1093/ajcn/69.4.767S.
- Background: PubMed 10195602Stevens J, Cornell CE, Story M, French SA, Levin S, Becenti A, Gittelsohn J, Going SB, Reid R. Development of a questionnaire to assess knowledge, attitudes, and behaviors in American Indian children. Am J Clin Nutr. 1999 Apr;69(4 Suppl):773S-781S. doi: 10.1093/ajcn/69.4.773S.
- Background: PubMed 10195603Weber JL, Cunningham-Sabo L, Skipper B, Lytle L, Stevens J, Gittelsohn J, Anliker J, Heller K, Pablo JL. Portion-size estimation training in second- and third-grade American Indian children. Am J Clin Nutr. 1999 Apr;69(4 Suppl):782S-787S. doi: 10.1093/ajcn/69.4.782S.
- Background: PubMed 10195604Going SB, Levin S, Harrell J, Stewart D, Kushi L, Cornell CE, Hunsberger S, Corbin C, Sallis J. Physical activity assessment in American Indian schoolchildren in the Pathways study. Am J Clin Nutr. 1999 Apr;69(4 Suppl):788S-795S. doi: 10.1093/ajcn/69.4.788S.
- Background: PubMed 10195605Davis SM, Going SB, Helitzer DL, Teufel NI, Snyder P, Gittelsohn J, Metcalfe L, Arviso V, Evans M, Smyth M, Brice R, Altaha J. Pathways: a culturally appropriate obesity-prevention program for American Indian schoolchildren. Am J Clin Nutr. 1999 Apr;69(4 Suppl):796S-802S. doi: 10.1093/ajcn/69.4.796S.
- Background: PubMed 10195607Snyder P, Anliker J, Cunningham-Sabo L, Dixon LB, Altaha J, Chamberlain A, Davis S, Evans M, Hurley J, Weber JL. The Pathways study: a model for lowering the fat in school meals. Am J Clin Nutr. 1999 Apr;69(4 Suppl):810S-815S. doi: 10.1093/ajcn/69.4.810S.
- Background: PubMed 10195608Helitzer DL, Davis SM, Gittelsohn J, Going SB, Murray DM, Snyder P, Steckler AB. Process evaluation in a multisite, primary obesity-prevention trial in American Indian schoolchildren. Am J Clin Nutr. 1999 Apr;69(4 Suppl):816S-824S. doi: 10.1093/ajcn/69.4.816S.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H. Stevens
University of North Carolina
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing exercise and diet in people with Cardiovascular Diseases and Sedentary Behaviors, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000545, which also lists 38 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 29 Jul 2016.