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

NCT02803853 | Completed DMC

• 1 other identifier: 1R01HL122150-01A1
• Study Type: interventional
• Target: 876
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Native American; Obesity; Multi level; Policy; Schools; Worksite; Social Media; Food Store

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The number of health-related policies under review

  Up to 4 years

• Percent of time spent in sedentary activity and total activity counts

  Up to 4 years

• Intake of fruits and vegetable servings,fiber, total energy and fat intake.

  Up to 4 years

• Waist to hip ratio

  Up to 4 years

• Percent body fat

  Up to 4 years

Other Outcomes (1)

• Knowledge, self-efficacy, outcome expectations, and behavioral intentions

  Up to 4 years

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Intervention BEHAVIORAL

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).

Intervention

Eligibility Criteria

• Age: 6 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (3)

• Redmond LC, Wensel CR, Estrade M, Fleischhacker SE, Poirer L, Jock BWI, Gittelsohn J. Dietary Outcomes of a Multilevel, Multicomponent, Cluster Randomized Obesity Intervention in 6 Native American Communities in the Upper Midwest and Southwest United States. Curr Dev Nutr. 2023 Feb 6;7(6):100043. doi: 10.1016/j.cdnut.2023.100043. eCollection 2023 Jun.

  PMID: 37396963 DERIVED

• 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.

  PMID: 35310617 DERIVED

• 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.

  PMID: 28114926 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Methods

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Joel Gittelsohn, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 17, 2016
• Study Start: April 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: October 6, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)