NCT00905411

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

June 17, 2013

Status Verified

November 1, 2011

Enrollment Period

4.8 years

First QC Date

May 18, 2009

Last Update Submit

June 13, 2013

Conditions

Keywords

Overweightblood pressureDASH dietPacificchildren

Outcome Measures

Primary Outcomes (1)

  • 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")

    Feb 2008 - Feb 2012

Study Arms (2)

Attention Control / Usual Care

NO INTERVENTION

Intervention

EXPERIMENTAL
Behavioral: PacDASH intervention

Interventions

Effect of the PacDASH intervention on nutrition and physical activity behavior of children. 15 months study.

Intervention

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Diabetes Mellitis
  • Polycystic Ovarian Syndrome
  • Gastroesophageal Reflux
  • Gallbladder disease
  • Non alcoholic fatty liver disease
  • Pseudo Tumor cerebri
  • Slipped capital femoral epiphysis
  • Blount's disease
  • Obstructive Sleep Apnea/Sleep Disturbance
  • Other chronic disease conditions that would affect participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Center for Health Research, Hawaii

Honolulu, Hawaii, 96817, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rachel Novotny, PhD,RD

    Kaiser Permanente Center for Health Research Hawaii, University of Hawaii, Human Nutrition, Food, Animal Sciences Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2009

First Posted

May 20, 2009

Study Start

February 1, 2008

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

June 17, 2013

Record last verified: 2011-11

Locations