Engaging Tribal Policy Makers to Improve the Food and Physical Activity Environments in American Indian Communities (OPREVENT2)

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02803853

1R01HL122150-01A1

Details and patient eligibility

About

The overall objective of the study is to reduce adult obesity in participating American Indian (AI) communities and to improve understanding of the behavioral and environmental factors affecting obesity in these settings.

Full description

The investigators plan to accomplish this objective by developing, implementing, and evaluating a randomized controlled trial of an intervention to improve diet and physical activity-related risk factors of obesity. A previous iteration of the intervention trial, called Obesity Prevention Research and Evaluation of InterVention Effectiveness in NaTive North Americans (OPREVENT) was implemented in five American Indian communities in Michigan and New Mexico. OPREVENT was a multi-level, multi-component intervention functioning at the community, institution, household, and individual levels and was implemented in schools, food stores, and worksites. Prior to OPREVENT, the research team has run multi-level interventions by working with schools and food stores in Native North American (NNA) communities1-6. For this new trial, named OPREVENT2, the research team will expand on the collective experience working on obesity prevention interventions in American Indian (AI) settings by developing complementary policy and social media components to support long-term sustainability of the OPREVENT intervention. OPREVENT2 will be implemented in six new AI communities.

Enrollment: 876 patients

Sex: All

Ages: 6 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• With the exception of the school intervention, which will only include teachers of grades 2-6 and students in grades 2-6 (ages 6-13), all community members will be included in the intervention.

Gender, Age and Locale

• The investigators will work with male and female schoolchildren and adults, aged 6-13 and 18-75 years who live in one of the participating tribal communities.

Exclusion criteria

• No adult community members will be excluded from the intervention as they are "passive" media and environmental changes, and available to everyone.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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876 participants in 2 patient groups

Intervention

Experimental group

Description:

The intervention is a multi-level, multi-component intervention designed to increase access to and consumption of healthier foods in Native American Communities. Intervention components will occur at the policy level; food retail outlet level; neighborhood level- schools and worksites, and household level.

Treatment:

Behavioral: Intervention

Control

No Intervention group

Description:

Similar to many community- based public health research programs, the control arm will not receive any intervention components during the initial intervention period. However, after all assessments are completed they will receive a 'delayed intervention' protocol, where the community receives the intervention elements as described in the intervention arm after assessment measures have been completed.