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Preventing American Indian Children From Becoming Overweight

Primordial Prevention of Overweight in American Indian Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00245180
Enrollment
577
Registered
2005-10-27
Start date
2006-05-31
Completion date
2012-09-30
Last updated
2014-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Heart Diseases, Obesity

Brief summary

The purpose of this study is to establish an intervention to keep American Indian/Alaskan Native (AI/AN) children from becoming overweight.

Detailed description

BACKGROUND: AI/AN children have overweight rates that are 18 to 30 percent higher than the general American population of children. Adult obesity has early antecedents, and data show that eating and physical activity behaviors are formed and set as early as 3 years of age, through primary socialization within families. Yet there are few, if any, obesity prevention programs that target children younger than 3 years of age. DESIGN NARRATIVE: This is a community-partnered randomized study to prevent early childhood overweight in AI/AN children. A birth cohort of about 780 children from six Indian communities born over a period 18 months will be randomized by community to either a control (3 communities) or intervention condition (3 communities). The intervention comprises a community-wide intervention coupled with individualized family counseling to improve nutrition and physical activity in infants and toddlers. Nutrition goals are to increase breastfeeding initiation and sustainability, limit sugared beverages for infants and toddlers, and make healthful choices during weaning and solid food introduction. Physical activity goals include promoting motor development, limiting video/TV viewing, and creating play opportunities for infants and toddlers. Intervention approaches and methods used in the pilot study on which this project is based will be combined with new formative data collected at the beginning of the project to enhance the intervention's feeding and physical activity components. Each component in the community-wide interventions will be collaboratively designed with the tribes, and tailored to each community's needs. Trained peer counselors will deliver the family interventions, during a series of 12 cluster visits, each covering a different developmental stage of the infant/toddler.

Interventions

BEHAVIORALExercise
BEHAVIORALDiet

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Women who have had uncomplicated pregnancies * Women who agree to have their child enrolled in the study and followed for 30 months * Women who are not planning to leave their area within 2 years of study start

Exclusion criteria

* Women whose children have a serious illness known to affect normal growth

Design outcomes

Primary

MeasureTime frame
BMIbirth, 6,12,18, and 24 months

Secondary

MeasureTime frameDescription
feeding0-24 monthsBreastfeeding, (initiation and maintenance), introduction of solids.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026