Clinical trial NCT02803853: Engaging Tribal Policy Makers to Improve the Food and Physical Activity Environments in American Indian Communities
Official title: Engaging Tribal Policy Makers to Sustain Improvements to the Food and Physical Activity Environments in American Indian Communities (OPREVENT2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Native American
Obesity
Multi level
Policy
Schools
Worksite
Social Media
Food Store
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 876
Sex: ALL
Minimum age (years): 6
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: Up to 4 years
Secondary outcomes:
measure: The number of health-related policies under review
timeFrame: Up to 4 years
measure: Percent of time spent in sedentary activity and total activity counts
timeFrame: Up to 4 years
measure: Intake of fruits and vegetable servings,fiber, total energy and fat intake.
timeFrame: Up to 4 years
measure: Waist to hip ratio
timeFrame: Up to 4 years
measure: Percent body fat
timeFrame: Up to 4 years
Other outcomes:
measure: Knowledge, self-efficacy, outcome expectations, and behavioral intentions
timeFrame: Up to 4 years
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Joel Gittelsohn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jock BWI, Maudrie T, Fleischhacker S, Porter KP, Gittelsohn J. Journey to Promoting Structural Change for Chronic Disease Prevention: Examining the Processes for Developing Policy, Systems, and Environmental Supports in Native American Nations. Curr Dev Nutr. 2022 Mar 16;6(3):nzab031. doi: 10.1093/cdn/nzab031. eCollection 2022 Mar.
citation: Gittelsohn J, Jock B, Redmond L, Fleischhacker S, Eckmann T, Bleich SN, Loh H, Ogburn E, Gadhoke P, Swartz J, Pardilla M, Caballero B. OPREVENT2: Design of a multi-institutional intervention for obesity control and prevention for American Indian adults. BMC Public Health. 2017 Jan 23;17(1):105. doi: 10.1186/s12889-017-4018-0.