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Cardiovascular DiseasesNCT00123032

School- and Home-Based Program to Prevent Obesity in American Indian Children

A study testing Diet and Exercise in people with Cardiovascular Diseases and Heart Diseases, run by University of Minnesota at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to prevent excessive weight gain among kindergarten and first grade American Indian children using improved diet and increased physical activity at home and at school. Read more about this study

Who is it for?
Ages 5 to 7 years
Conditions the study is for
Cardiovascular Diseases, Heart Diseases, Obesity
What is being tested?
Diet and Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesUnited States
Study dates
Jan 2005to Dec 2011
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 5 to 7 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Enrolled in kindergarten at one of the participating elementary schools on the Pine Ridge or Rosebud reservations in South Dakota

Who cannot join

  • Schools who do not meet the criteria stated above and are not willing to sign the memorandum of agreement outlining expectations of the school and the University of Minnesota.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of Minnesota Twin Cities

    Minneapolis, Minnesota, 55454

  • University of Minnesota

    Minneapolis, Minnesota, 55454

Other trials in United States

About this study

Official title: Bright Start: Obesity Prevention in American Indian Children

The purpose of this study is to prevent excessive weight gain among kindergarten and first grade American Indian children using improved diet and increased physical activity at home and at school.

Read the detailed description

BACKGROUND:

Obesity has reached epidemic proportions nationwide among children, adolescents, and adults and is considered one of the most serious health problems facing Americans today. There is a higher prevalence of obesity among ethnic minority groups and those with a lower family income. American Indian children and adults are among those with the highest rates of obesity and related diseases. Young American Indians have high rates of type 2 diabetes, and the rates appear to be increasing substantially. Obesity in American Indian children has serious implications for their immediate and long-term health. Unless this trend is reversed, American Indian populations will be burdened by an unprecedented increase in the incidence of chronic diseases, such as type 2 diabetes and cardiovascular disease.

The high prevalence of obesity among American Indian children and the associated health and financial burdens warrant strong and effective prevention efforts. While the prevention of childhood obesity has risen to the top of the list of public health priorities, relatively little research has focused on childhood obesity prevention, especially for high-risk populations. The development and evaluation of innovative, culturally appropriate, and effective strategies to prevent excessive weight gain is critical, particularly for American Indian youth. Early prevention efforts are especially important given the substantial evidence that eating and physical activity habits are established in early childhood and continue into adulthood. Adopting healthy eating and physical activity habits early in life is an effective way of preventing obesity and related diseases. The best intervention to prevent obesity in children should target the two most prominent influences on the young child's eating and physical activity behaviors: the school and the family. Obesity in American Indian children begins very early in life, which suggests that interventions need to begin early. Research has shown that 43% of American Indian 5-6 year olds in South Dakota are already overweight. Thus, targeting children in this young age group may be advantageous.

DESIGN NARRATIVE:

The study involves 14 schools on the Pine Ridge and Rosebud reservations, which are two Lakota reservations in South Dakota. Seven schools will be randomly assigned to the intervention condition and 7 schools to the control condition. Schools will be assigned to one of the two groups after baseline measures have been completed. The focus of this intervention, the Ohiyu lyojanjan - Bright Start Program, is to create dietary and physical activity environmental change at school and home. The intervention will follow 500 children in kindergarten for 16 months through the end of 1st grade. There will be 4 schools on the Rosebud reservation and 10 schools on the Pine Ridge reservation assigned to two groups. The two groups will begin the study one year apart; the first group will have baseline measures assessed in the fall of 2005 and begin the intervention in January 2006, and the second group will have baseline measures assessed in the fall of 2006 and begin the intervention in January 2007. This staggered design will allow for more contact with participating schools and families by key study staff, increased monitoring and control of the intervention within schools, and decreased staff costs. The intervention will focus on changing the school and home environments related to physical activity and food. The school physical activity environmental intervention component will incorporate 60 minutes of daily physical activity at school for kindergarten and 1st grade students through a combination of physical education classes, a classroom walking program, in-class activity breaks, and active morning and afternoon recess. The school food environment intervention will focus on improving school meals (breakfast and lunch), classroom snacks, and teacher classroom food practices. The intervention will target the school food service to decrease availability of high-fat and high-sugar foods, regulate portion control of foods served, and increase fruits (not juice) and vegetables served. The family intervention will address the household food and physical activity environment and family dietary and physical activity behaviors. Because parents of kindergarten children in the selected schools will be recruited for participation prior to the school treatment assignments, it may be problematic to engage all parents without providing anything to those who are assigned to the control condition. To foster parent interest in study participation, parents in the control group will be mailed monthly newsletters with general family recommendations for prevention of excess weight gain.

The major hypothesis is that by the end of the 16-month study, children in the intervention schools will have significantly lower body mass index (BMI) and body fat percentage after adjustment for baseline values, as compared to children in the control schools. The primary outcome measures in children are BMI and percent body fat. Secondary measures include child's total daily physical activity, nutrient and food-group analysis of school meals and snacks, and assessment of classroom food and physical activity practices. Child measures will occur at the beginning of kindergarten, at the end of kindergarten (BMI only), and at the end of the 1st grade. Parents will be surveyed at the beginning of their child's kindergarten year, and when their child is at the end of 1st grade. Parent assessments will include measures of household food availability and reports of their own and their child's eating and physical activity behaviors.

Being tested
Diet, Exercise
Medical subject headings
Cardiovascular Diseases, Heart Diseases, Obesity

What participants receive

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

  • DietBehavioural

    Increase the availability of fruits and vegetables, serve recommended portion sizes and reduce availability of excessive energy-dense foods at school cafeterias to improve the diet of participants at school breakfast, lunch and snacks.

  • ExerciseProcedure or surgery

    Increase active recess time, implement classroom action breaks and increase school PE class time to increase physical activity among participants.

Study groups in NCT00123032
Study groupRoleWhat they receive
1ExperimentalThis group will focus on improving their diet and increasing physical activity at home and at school.
Receives: Behavioral: Diet; Procedure: Exercise
2No interventionA control group will not receive any intervention.

What is being measured

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

  1. BMI of children

    Measured: Fall 2005 through Summer 2008

  2. Percentage of body fat of children (measured at the end of the 1st grade school year)

    Measured: Baseline and followup

Secondary outcomes (6)
  1. Total daily physical activity level of children

    Measured: Daily during intervention period

  2. Nutrient and food group analysis of school meals and snacks

    Measured: Baseline and followup

  3. Assessment of classroom food and physical activity practices

    Measured: Daily during intervention period

  4. Measures of household food availability

    Measured: Baseline and followup

  5. Parent reports of their eating and physical activity behaviors

    Measured: Baseline and followup

  6. Parent reports of their children's eating and physical activity behaviors (measured at the end of the 1st grade school year)

    Measured: Baseline and followup

Timeline

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

  1. First posted22 Jul 2005 (estimated)
  2. Study startJan 2005
  3. Primary completionAug 2008
  4. Study completionDec 2011 (estimated)

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00123032
Sponsor's protocol ID
228
Status last verified
Jul 2017
First submitted
20 Jul 2005
Last updated
24 Jul 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Zhang J, Himes JH, Hannan PJ, Arcan C, Smyth M, Rock BH, Story M. Summer effects on body mass index (BMI) gain and growth patterns of American Indian children from kindergarten to first grade: a prospective study. BMC Public Health. 2011 Dec 23;11:951. doi: 10.1186/1471-2458-11-951.

    PubMed 22192795

Questions about this trial

What is this clinical trial studying?

A study testing Diet and Exercise in people with Cardiovascular Diseases and Heart Diseases, run by University of Minnesota at 2 sites 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: withdrawn, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.

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?

BMI of children (time frame: Fall 2005 through Summer 2008). The study lists 2 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 NCT00123032, which also lists 1 linked publication.

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 24 Jul 2017.

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