Preventing American Indian Children From Becoming Overweight
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|ClinicalTrials.gov Identifier: NCT00245180|
Recruitment Status : Completed
First Posted : October 27, 2005
Last Update Posted : March 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Heart Diseases Obesity||Behavioral: Diet Behavioral: Exercise||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||577 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Primordial Prevention of Overweight in American Indian Children|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
No Intervention: control
Primary and secondary data collected as in intervention arm. Dental screenings will be done once a year as a service.
|Behavioral: Diet Behavioral: Exercise|
- BMI [ Time Frame: birth, 6,12,18, and 24 months ]
- feeding [ Time Frame: 0-24 months ]Breastfeeding, (initiation and maintenance), introduction of solids.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245180
|Principal Investigator:||Njeri Karanja||Kaiser Foundation Hospitals|