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

Study Overview
=================
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.

Official Title
-----------------
Engaging Tribal Policy Makers to Sustain Improvements to the Food and Physical Activity Environments in American Indian Communities (OPREVENT2)

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Intervention


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Behavioral: Intervention<br>* Intervention components will occur at the policy level (working with tribal leaders makers to sustain intervention components; food retail outlet level (working with grocery stores and owners to stock, promote, and sell healthier foods and beverages); neighborhood level (working with worksites and schools to deliver nutrition intervention sessions to youth and adults in intervention neighborhoods); household level (providing a social media program that provides parents and caregivers tips for healthier eating).<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) | The investigators will compare the mean change in BMI of participants living in intervention communities to those in the comparison communities, using data from the Adult Impact Questionnaire (AIQ). The investigators expect that the OPREVENT2 intervention will result in a 1.3 kg/m2 change in mean BMI, due to the multi-level, multi-component reinforcing design of this trial. These analyses will be adjusted for baseline value, participant and household (HH) covariates. | Up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of health-related policies under review | The investigators will assess potential impact of the program by the increased number of health-related policies under review. The investigators will work to ensure that participating tribal leaders have the evidence base and tools to pass health-related policies and specifically policies that will work to support increased access to healthy foods and physical activity resources within communities. | Up to 4 years | 
| Percent of time spent in sedentary activity and total activity counts | The investigators will examine mean changes in participants' amount of time spent sitting, walking, doing moderate physical activity or doing vigorous physical activity (in the prior week) comparing pre- and post-intervention using the modified International Physical Activity Questionnaire-Short Form (IPAQ-SF). The investigators will use regression analysis to determine if participants' mean time spent inactive (i.e., sitting) decreases from pre- to post-intervention comparing intervention and control groups, adjusting for participant covariates and HH covariates. | Up to 4 years | 
| Intake of fruits and vegetable servings,fiber, total energy and fat intake. | Using a modified version of the Block Food Frequency Questionnaire (FFQ) the investigators will examine mean changes in participants' intake of fruit and vegetable servings (separately and aggregated), fiber intake, total energy and fat intake from pre- to post-intervention in intervention and control groups, using linear regression analysis, adjusting for baseline value of the outcome variable, participant covariates (e.g., age, sex) and household covariates (e.g., income, age and education). | Up to 4 years | 
| Waist to hip ratio | The investigators will compare the mean change in waist to hip ratio of participants living in intervention communities to those in the comparison communities, using data from the Adult Impact Questionnaire (AIQ). These analyses will be adjusted for baseline value, participant and household (HH) covariates. | Up to 4 years | 
| Percent body fat | The investigators will compare the mean change in % body fat of participants living in intervention communities to those in the comparison communities, using data from the Adult Impact Questionnaire (AIQ). These analyses will be adjusted for baseline value, participant and household (HH) covariates. | Up to 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Social Media, Food Store, Native American, Obesity, Multi level, Policy, Schools, Worksite