NCT Number: NCT00245180
Preventing American Indian Children From Becoming Overweight
The purpose of this study is to establish an intervention to keep American Indian/Alaskan Native (AI/AN) children from becoming overweight.
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Conditions
Age range
15 year–40 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Exercise
BehavioralPrimary outcomes
-
BMI
Time frame: birth, 6,12,18, and 24 months
Secondary outcomes
-
feeding
Time frame: 0-24 months
Breastfeeding, (initiation and maintenance), introduction of solids.
Sponsors and collaborators
Lead sponsor
Kaiser Permanente
Other
Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
Registry information
Official study title
Primordial Prevention of Overweight in American Indian Children
Important dates
- Study start
- 2006
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Oct 27, 2005
- Registry last updated
- Mar 12, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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