OverweightPacDASHNCT00905411
Pacific Kids DASH for Health
A study testing PacDASH intervention in people with Overweight and Blood Pressure, run by Kaiser Permanente at 1 site in United States.
Trial summary
The increasing prevalence of childhood overweight has been found to be related to decreased levels of physical activity (PA) and increased energy content of the diet. Childhood offers an opportunity to develop and support health-promoting behaviors. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Blood Pressure
- What is being tested?
- PacDASH intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Feb 2013
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 5 - 8 years old
- >85th up to 98th BMI-for-age percentile (overweight)
- Children with a primary care provider at MAP
- Lives on Oahu
- Due for, or scheduled for, a well-child/physical exam visit during months of the pilot study
Who cannot join
- Diabetes Mellitis
- Polycystic Ovarian Syndrome
- Gastroesophageal Reflux
- Gallbladder disease
- Non alcoholic fatty liver disease
- Pseudo Tumor cerebri
Show all 10Show fewer
- Slipped capital femoral epiphysis
- Blount's disease
- Obstructive Sleep Apnea/Sleep Disturbance
- Other chronic disease conditions that would affect participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Center for Health Research, Hawaii
Honolulu, Hawaii, 96817
About this study
The increasing prevalence of childhood overweight has been found to be related to decreased levels of physical activity (PA) and increased energy content of the diet. Childhood offers an opportunity to develop and support health-promoting behaviors. Pacific Kids DASH for Health (PacDASH) is a community-based intervention that links food, PA, and health, and targets overweight children in Hawaii with a goal of preventing further weight gain. Components of the intervention include a food and PA prescription delivered by physicians at community-based health centers complemented with a toolbox of activities, behaviorally tailored messages, and PacDASH educational materials. This project will extend and apply the nationally recommended DASH eating pattern to children and the growing population of Asians and Pacific Islanders. The investigators will incorporate culturally preferred foods, recipes, and PA messages that meet DASH and other national guidelines. The approach will target child food behaviors and social and environmental cues that are important to making healthy food and PA choices and will provide steps to behavior change. Farmers markets at participating health centers are a support resource for activities. Providing access to, coupons for, and guidance about selecting and preparing fresh fruits and vegetables at a convenient health center farmers market will support increased intake of nutrient-rich foods among these children who are overweight and at risk for obesity.
Pacific Islanders are among the world's most obese populations while Asians, although of relatively low body mass index (BMI), carry much of their body fat in the upper body and exhibit greater health risk at the same BMI. Through this project, the investigators hope to learn more about body size and composition in children of the Pacific Region for whom there are few national data. In addition, evaluate the effectiveness of a community-based intervention within a health care system on managing overweight in children.
Read the detailed description
INTRODUCTION The ethnic groups of the Pacific Region are predominantly Pacific Islander and Asian.
Pacific Islanders (PacIsl) are among the world's most obese populations while Asians, although of relatively low body mass index (BMI), carry much of their body fat in the upper body and exhibit greater health risk at the same BMI. Childhood offers an opportunity to develop and support health-promoting behaviors. This project will extend and apply the nationally recommended DASH eating pattern 115, developed for White, African American and Hispanic adults, to children and to the growing population of Asians and PacIsl. We will incorporate culturally-preferred foods, recipes, and physical activities that meet DASH and other national guidelines, with adaptations for children. We will develop the Pacific Kids DASH for Health (PacDASH) intervention in Hawaii, where the majority is of Asian and PacIsl ancestry.
Linking food and health systems is critical to prevent obesity. The PacDASH intervention will include a food and physical activity (PA) prescription delivered by a physician at a community-based health center (HC), in partnership with farmers' markets (FM) that are based at the HC, and complemented with a toolbox of related activities. The intervention approach supports child food behaviors and social and environmental cues, which are important to making healthy food and PA choices. Linking physicians and health with farmers and food at a convenient HC FM will support increased intake of nutrient-rich, less energy dense foods among children of understudied ethnic groups who are at high risk for obesity.
Project Goal Our goal is to develop and evaluate the effectiveness of a community-based intervention that links food and health, and targets children of the Pacific Region who are overweight, in order to slow and prevent further weight gain (for children to "grow into their weight").
Specific Objectives
- To develop and evaluate the impact of the PacDASH intervention on preventing weight gain and improving blood pressure in children of the Pacific Region.
- To further develop and test the Pacific Tracker (PacTrac) dietary assessment and education tool by incorporating updated MyPyramid 112 reference data and educational output, and
- To enhance PacTrac with an expert system (ES) of behaviorally-tailored messages and output.
- To evaluate the effect of the PacDASH intervention on nutrition and physical activity behavior of children.
- To describe environmental, social, economic and cultural factors associated with body size and composition of children of the Pacific Region, for whom there are few national data.
- To examine body size and composition of children of the Pacific Region according to several measures.
- To examine the influence of individual PacIsl ethnic groups on body size and composition.
- Conditions
- Overweight, Blood Pressure
- Being tested
- PacDASH intervention
- Keywords
- Overweight, blood pressure, DASH diet, Pacific, children
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PacDASH interventionBehavioural
Effect of the PacDASH intervention on nutrition and physical activity behavior of children.
15 months study.
| Study group | Role | What they receive |
|---|---|---|
| Attention Control / Usual Care | No intervention | Not described |
| Intervention | Experimental | Not described Receives: Behavioral: PacDASH intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop/evaluate effectiveness of a community-based intervention targets children of the Pacific Region who are overweight in order to slow and prevent further weight gain (for children to "grow into their weight")
Measured: Feb 2008 - Feb 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startFeb 2008
- Primary completionDec 2012
- Study completionFeb 2013
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 OverweightStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hawaii
- Responsible party
- Sponsor
- Investigators
- Rachel Novotny, PhD,RD, Principal investigator, Kaiser Permanente Center for Health Research Hawaii, University of Hawaii, Human Nutrition, Food, Animal Sciences Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905411
- Sponsor's protocol ID
- 2008-55215-18821
- Other IDs
- 2007-04557, 2008
- Acronym
- PacDASH
- Status last verified
- Nov 2011
- First submitted
- 18 May 2009
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Novotny R, Nigg CR, Li F, Wilkens LR. Pacific kids DASH for health (PacDASH) randomized, controlled trial with DASH eating plan plus physical activity improves fruit and vegetable intake and diastolic blood pressure in children. Child Obes. 2015 Apr;11(2):177-86. doi: 10.1089/chi.2014.0141. Epub 2015 Feb 11.
PubMed 25671796
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pacific Kids DASH for Health
- ClinicalTrials.gov ID
- NCT00905411
- Acronym / sponsor ID
- PacDASH / 2008-55215-18821
- Conditions
- Overweight, Blood Pressure
- Keywords
- Overweight, blood pressure, DASH diet, Pacific, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- University of Hawaii
- Study start
- Feb 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 20 May 2009 (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 increasing prevalence of childhood overweight has been found to be related to decreased levels of physical activity (PA) and increased energy content of the diet. Childhood offers an opportunity to develop and support health-promoting behaviors. Pacific Kids DASH for Health (PacDASH) is a community-based intervention that links food, PA, and health, and targets overweight children in Hawaii with a goal of preventing further weight gain. Components of the intervention include a food and PA prescription delivered by physicians at community-based health centers complemented with a toolbox of activities, behaviorally tailored messages, and PacDASH educational materials. This project will extend and apply the nationally recommended DASH eating pattern to children and the growing population of Asians and Pacific Islanders. The investigators will incorporate culturally preferred foods, recipes, and PA messages that meet DASH and other national guidelines. The approach will target child food behaviors and social and environmental cues that are important to making healthy food and PA choices and will provide steps to behavior change. Farmers markets at participating health centers are a support resource for activities. Providing access to, coupons for, and guidance about selecting and preparing fresh fruits and vegetables at a convenient health center farmers market will support increased intake of nutrient-rich foods among these children who are overweight and at risk for obesity.
Pacific Islanders are among the world's most obese populations while Asians, although of relatively low body mass index (BMI), carry much of their body fat in the upper body and exhibit greater health risk at the same BMI. Through this project, the investigators hope to learn more about body size and composition in children of the Pacific Region for whom there are few national data. In addition, evaluate the effectiveness of a community-based intervention within a health care system on managing overweight in children.
Detailed description
INTRODUCTION The ethnic groups of the Pacific Region are predominantly Pacific Islander and Asian.
Pacific Islanders (PacIsl) are among the world's most obese populations while Asians, although of relatively low body mass index (BMI), carry much of their body fat in the upper body and exhibit greater health risk at the same BMI. Childhood offers an opportunity to develop and support health-promoting behaviors. This project will extend and apply the nationally recommended DASH eating pattern 115, developed for White, African American and Hispanic adults, to children and to the growing population of Asians and PacIsl. We will incorporate culturally-preferred foods, recipes, and physical activities that meet DASH and other national guidelines, with adaptations for children. We will develop the Pacific Kids DASH for Health (PacDASH) intervention in Hawaii, where the majority is of Asian and PacIsl ancestry.
Linking food and health systems is critical to prevent obesity. The PacDASH intervention will include a food and physical activity (PA) prescription delivered by a physician at a community-based health center (HC), in partnership with farmers' markets (FM) that are based at the HC, and complemented with a toolbox of related activities. The intervention approach supports child food behaviors and social and environmental cues, which are important to making healthy food and PA choices. Linking physicians and health with farmers and food at a convenient HC FM will support increased intake of nutrient-rich, less energy dense foods among children of understudied ethnic groups who are at high risk for obesity.
Project Goal Our goal is to develop and evaluate the effectiveness of a community-based intervention that links food and health, and targets children of the Pacific Region who are overweight, in order to slow and prevent further weight gain (for children to "grow into their weight").
Specific Objectives
- To develop and evaluate the impact of the PacDASH intervention on preventing weight gain and improving blood pressure in children of the Pacific Region.
- To further develop and test the Pacific Tracker (PacTrac) dietary assessment and education tool by incorporating updated MyPyramid 112 reference data and educational output, and
- To enhance PacTrac with an expert system (ES) of behaviorally-tailored messages and output.
- To evaluate the effect of the PacDASH intervention on nutrition and physical activity behavior of children.
- To describe environmental, social, economic and cultural factors associated with body size and composition of children of the Pacific Region, for whom there are few national data.
- To examine body size and composition of children of the Pacific Region according to several measures.
- To examine the influence of individual PacIsl ethnic groups on body size and composition.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Control / Usual Care | No intervention | – |
| Intervention | Experimental | Behavioral: PacDASH intervention |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 5 - 8 years old
- >85th up to 98th BMI-for-age percentile (overweight)
- Children with a primary care provider at MAP
- Lives on Oahu
- Due for, or scheduled for, a well-child/physical exam visit during months of the pilot study
Key exclusion criteria (10 listed)
- Diabetes Mellitis
- Polycystic Ovarian Syndrome
- Gastroesophageal Reflux
- Gallbladder disease
- Non alcoholic fatty liver disease
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 |
|---|---|---|
| PacDASH interventionEffect of the PacDASH intervention on nutrition and physical activity behavior of children. 15 months study. | Behavioural | Intervention |
Primary outcome
Develop/evaluate effectiveness of a community-based intervention targets children of the Pacific Region who are overweight in order to slow and prevent further weight gain (for children to "grow into their weight")
Time frame: Feb 2008 - Feb 2012
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 17 Jun 2013.
- Derived from this study: PubMed 25671796Novotny R, Nigg CR, Li F, Wilkens LR. Pacific kids DASH for health (PacDASH) randomized, controlled trial with DASH eating plan plus physical activity improves fruit and vegetable intake and diastolic blood pressure in children. Child Obes. 2015 Apr;11(2):177-86. doi: 10.1089/chi.2014.0141. Epub 2015 Feb 11.
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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.
Rachel Novotny, PhD,RD principal investigator
Kaiser Permanente Center for Health Research Hawaii, University of Hawaii, Human Nutrition, Food, Animal Sciences Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PacDASH intervention in people with Overweight and Blood Pressure, run by Kaiser Permanente 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 5 inclusion and 10 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 17 Jun 2013. 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?
Develop/evaluate effectiveness of a community-based intervention targets children of the Pacific Region who are overweight in order to slow and prevent further weight gain (for children to "grow into their weight") (time frame: Feb 2008 - Feb 2012). 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 NCT00905411, 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 17 Jun 2013.