ObesityOPREVENT2NCT02803853
Engaging Tribal Policy Makers to Improve the Food and Physical Activity Environments in American Indian Communities
A study testing Intervention in people with Obesity, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 876 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- No adult community members will be excluded from the intervention as they are "passive" media and environmental changes, and available to everyone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Engaging Tribal Policy Makers to Sustain Improvements to the Food and Physical Activity Environments in American Indian Communities (OPREVENT2)
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Intervention
- Keywords
- Native American, Obesity, Multi level, Policy, Schools, Worksite, Social Media, Food Store
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 years
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startApr 2015
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 876 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joel Gittelsohn, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803853
- Sponsor's protocol ID
- 1R01HL122150-01A1
- Acronym
- OPREVENT2
- Status last verified
- Oct 2022
- First submitted
- 10 Jun 2016
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The proposed data sharing plan is intended to make study data as widely and freely available as possible, while safeguarding the privacy of participants, and protecting confidentiality. The data sharing plan includes additional stages of review and approval by the Navajo and Indian Health Services (IHS) Institutional Review Boards (IRBs). The investigators will strip the final dataset of personal identifiers prior to release for sharing. As even aggregated data may be perceived as stigmatizing, the investigators will make the data available to users under a data-sharing agreement that provides for: 1 initial approval of the data sharing request by the investigator, Navajo/IHS IRBs; 2 a commitment to not identifying participating communities without the express permission of that tribe's authorities; 3 a commitment to destroying or returning the data after analyses are completed; and 4 a commitment to having all manuscripts/documents approved by the Navajo/IHS IRBs prior to publication.
Publications
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.
PubMed 37396963Jock 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.
PubMed 35310617Gittelsohn 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.
PubMed 28114926
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Tribal Policy Makers to Sustain Improvements to the Food and Physical Activity Environments in American Indian Communities (OPREVENT2)
- ClinicalTrials.gov ID
- NCT02803853
- Acronym / sponsor ID
- OPREVENT2 / 1R01HL122150-01A1
- Conditions
- Obesity
- Keywords
- Native American, Obesity, Multi level, Policy, Schools, Worksite, Social Media, Food Store
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 876 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionThe 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. |
| 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. |
Who may qualify
- Ages
- 6 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- No adult community members will be excluded from the intervention as they are "passive" media and environmental changes, and available to everyone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionIntervention 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). | Behavioural | Intervention |
Primary outcome
Body Mass Index (BMI)
Time frame: Up to 4 years
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.
5 secondary outcomes
The number of health-related policies under review
Time frame: Up to 4 years
Percent of time spent in sedentary activity and total activity counts
Time frame: Up to 4 years
Intake of fruits and vegetable servings,fiber, total energy and fat intake.
Time frame: Up to 4 years
Waist to hip ratio
Time frame: Up to 4 years
Percent body fat
Time frame: Up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Derived from this study: PubMed 37396963Redmond 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.
- Derived from this study: PubMed 35310617Jock 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.
- Derived from this study: PubMed 28114926Gittelsohn 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.
- Individual participant dataSharing planned: Yes. The proposed data sharing plan is intended to make study data as widely and freely available as possible, while safeguarding the privacy of participants, and protecting confidentiality. The data sharing plan includes additional stages of review and approval by the Navajo and Indian Health Services (IHS) Institutional Review Boards (IRBs). The investigators will strip the final dataset of personal identifiers prior to release for sharing. As even aggregated data may be perceived as stigmatizing, the investigators will make the data available to users under a data-sharing agreement that provides for: 1 initial approval of the data sharing request by the investigator, Navajo/IHS IRBs; 2 a commitment to not identifying participating communities without the express permission of that tribe's authorities; 3 a commitment to destroying or returning the data after analyses are completed; and 4 a commitment to having all manuscripts/documents approved by the Navajo/IHS IRBs prior to publication.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Gittelsohn, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Obesity, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (BMI) (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02803853, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.