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.
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
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- 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
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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- 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 group | Role | What they receive |
|---|---|---|
| 1 | Experimental | This group will focus on improving their diet and increasing physical activity at home and at school. Receives: Behavioral: Diet; Procedure: Exercise |
| 2 | No intervention | A control group will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI of children
Measured: Fall 2005 through Summer 2008
Percentage of body fat of children (measured at the end of the 1st grade school year)
Measured: Baseline and followup
Secondary outcomes (6)
Total daily physical activity level of children
Measured: Daily during intervention period
Nutrient and food group analysis of school meals and snacks
Measured: Baseline and followup
Assessment of classroom food and physical activity practices
Measured: Daily during intervention period
Measures of household food availability
Measured: Baseline and followup
Parent reports of their eating and physical activity behaviors
Measured: Baseline and followup
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.
- First posted22 Jul 2005 (estimated)
- Study startJan 2005
- Primary completionAug 2008
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 University of MinnesotaThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Story, MD, Study chair, University of Minnesota
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bright Start: Obesity Prevention in American Indian Children
- ClinicalTrials.gov ID
- NCT00123032
- Acronym / sponsor ID
- 228
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Dec 2011 (estimated)
- First posted
- 22 Jul 2005 (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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Diet, Procedure: ExerciseThis group will focus on improving their diet and increasing physical activity at home and at school. |
| 2 | No intervention | –A control group will not receive any intervention. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Enrolled in kindergarten at one of the participating elementary schools on the Pine Ridge or Rosebud reservations in South Dakota
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| DietIncrease 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. | Behavioural | 1 |
| ExerciseIncrease active recess time, implement classroom action breaks and increase school PE class time to increase physical activity among participants. | Procedure or surgery | 1 |
Primary outcome
BMI of children
Time frame: Fall 2005 through Summer 2008
Percentage of body fat of children (measured at the end of the 1st grade school year)
Time frame: Baseline and followup
6 secondary outcomes
Total daily physical activity level of children
Time frame: Daily during intervention period
Nutrient and food group analysis of school meals and snacks
Time frame: Baseline and followup
Assessment of classroom food and physical activity practices
Time frame: Daily during intervention period
Measures of household food availability
Time frame: Baseline and followup
Parent reports of their eating and physical activity behaviors
Time frame: Baseline and followup
Parent reports of their children's eating and physical activity behaviors (measured at the end of the 1st grade school year)
Time frame: Baseline and followup
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Derived from this study: PubMed 22192795Zhang 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.
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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.
Mary Story, MD study chair
University of Minnesota
2 sites in 1 country: see every site and its status.
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.