A multilevel obesity prevention trial for American Indian communities
| ISRCTN | ISRCTN76144389 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76144389 |
| Secondary identifying numbers | MDR-2009-05068 |
- Submission date
- 09/05/2018
- Registration date
- 11/05/2018
- Last edited
- 12/09/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims:
Obesity is a serious problem in the United States, especially in minority populations such as American Indian (AI) adults. There are many risk factors for overweight and obesity in AI adults, such as excess energy intake, high fat intake, and low physical activity (PA). For example,
AI diets have been described as being high in fat, low in fruit and vegetable intake, and high in high-fat or empty calorie foods like fry bread, home-fried potatoes, bacon, sausage, and soft drinks. As far as PA, about half of AI adults do not meet federal PA guidelines. Reports show low PA and high inactivity in Chippewa and Menominee, Anishinaabe First Nations, AI adults in Kansas, and participating tribes in the Strong Heart Family Study. Obesity interventions with a focus on improving dietary intake and PA have taken place in AI communities, but with varied success. The Obesity Prevention and Evaluation of InterVention Effectiveness in NaTive North Americans (OPREVENT) intervention was designed to address the problem of obesity at multiple levels within a community, thereby increasing the likelihood of program participation and exposure. This study aimed to recruit several AI communities, and 424 community members, to participate. The goal is to improve the food and PA environments within the communities such that they are supportive of obesity prevention behaviors, including eating a healthy diet and being physically active. The study's findings will help to serve as a model for similar programs to be implemented in other AI communities.
Who can participate?
Adults between the ages of 18-65 years who are either the main food shopper or main food preparer in their households, a tribal member, and not pregnant
What does the study involve?
Participants complete several questionnaires at the start of the study (summer 2011) and at follow-up (fall 2013 and spring 2014). The questionnaires ask for information about diet, physical activity, food shopping habits, health attitudes, and environment. Three communities are randomly allocated to receive the intervention immediately, and two are randomly allocated to receive the intervention delayed or after completion in the immediate communities. The delayed start allows all communities to receive the intervention. The intervention consists of several activities within food stores, worksites, schools, and other community locations such as health centers. Activities include taste tests, cooking demos, community walking events, and educational sessions. All activities are voluntary. Educational materials are also displayed and made available throughout the community.
What are the possible benefits and risks of participating?
Participants may benefit from improved health as measured by improved diet, being more physically active, or adopting healthier food and PA related behaviors. There should also be benefits to the community and future health status of community members because the results of the study are likely to influence future health programs. The main risk of participation is that there may be health, diet, and PA questions that are uncomfortable to answer.
Where is the study run from?
The study is run from the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland. However, the intervention takes place within the specific communities and is implemented by local field staff. Exact locations cannot be disclosed at this time in order to respect the privacy of the participating tribal communities, however, general locations include the upper Great Lakes and Southwest regions.
When is the study starting and how long is it expected to run for?
April 2010 to March 2015
Who is funding the study?
US Department of Agriculture National Institute of Food and Agriculture
Who is the main contact?
Dr Joel Gittelsohn
Contact information
Public
615 N. Wolfe St.
Baltimore
21205
United States of America
Study information
| Study design | Community randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Obesity prevention and research evaluation of intervention effectiveness in Native North Americans |
| Study acronym | OPREVENT |
| Study hypothesis | H1: Compared with control communities, program participants in intervention communities will have significantly increased intakes of fruits and vegetables and fiber and reduced total energy and fat intakes, and subsequently reduced percent of energy from fat. H2: Compared with control communities, program participants in intervention communities will have significantly reduced percent of time spent in sedentary activity and significantly increased total activity counts post-intervention. H3: Compared with control communities, program participants in intervention communities will have significantly lower BMI, waist circumference and percent body fat post-intervention. H4: Exposure to the intervention will be associated with improvements in knowledge, self- efficacy, risk perception, outcome expectations, behavioral intentions, and family social support which in turn will be associated with changes in PA and dietary behaviors. |
| Ethics approval(s) | 1. Johns Hopkins University Bloomberg School of Public Health Institutional Review Board (JHSPH IRB), 06/05/2010, #2866 2. Indian Health Service, 10/01/2011, #N10-N-11 3. Navajo Nation Human Research Review Board, 21/12/2010, #NNR-10.287 |
| Condition | Obesity |
| Intervention | The 14-month, six phase multi-level, multi-component obesity intervention administered by local trained field staff within food stores, schools, and worksites in five AI communities (three randomly allocated to receive the intervention immediately, two randomly allocated to receive the intervention delayed or after completion in the immediate communities). Intervention content aimed to change the food-purchasing environment, improve nutritional intake, and increase PA among community members. Intervention materials and activities included posters, brochures, flyers, newsletters, radio announcements, a school curriculum, giveaways, cooking demos, and taste tests. Outcomes were measured at follow-up in the fall of 2013 and spring of 2014, which was 14-18 months after baseline data collection in summer 2011. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Dietary quality and nutrient intake (fruit and vegetable servings, total energy, total fat), measured using brief FFQ and 24-hr recall at baseline (summer 2011) and follow-up (fall 2013 and spring 2014) 2. Physical activity (total PA, time spent sedentary), measured using IPAQ at baseline (summer 2011) and follow-up (fall 2013 and spring 2014) |
| Secondary outcome measures | 1. Anthropometric measures (BMI, waist circumference, % body fat) measured at baseline (summer 2011) and follow-up (fall 2013 and spring 2014) 2. Psychosocial variables, measured using Adult Impact Questionnaire developed based on formative work within the five communities, at baseline (summer 2011) and follow-up (fall 2013 and spring 2014) |
| Overall study start date | 01/04/2010 |
| Overall study end date | 31/03/2015 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Five clusters (communities); 85 participants per cluster; total n=424 |
| Total final enrolment | 299 |
| Participant inclusion criteria | 1. Between the ages of 18 and 65 years old 2. Living within the community for at least 30 days 3. Tribal member 4. Primary food shopper or preparer for the household |
| Participant exclusion criteria | 1. Currently pregnant |
| Recruitment start date | 01/07/2011 |
| Recruitment end date | 01/05/2013 |
Locations
Countries of recruitment
- United States of America
Study participating centre
21205
United States of America
Sponsor information
University/education
615 N. Wolfe St.
Baltimore
21201
United States of America
| Phone | +1 (0)410 955 3193 |
|---|---|
| JHSPH.irboffice@jhu.edu | |
"ROR" |
https://ror.org/00za53h95 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 11/05/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Study protocol and statistical analysis plan are not currently available. Study results will be disseminated in quarterly and yearly reports to all communities. Several papers based on formative work have already been published (see citation list below). The trialists intend to publish impact analysis in high-impact peer-reviewed journals within the next 12 months. 1. Gadhoke P, Christiansen K, Swartz J, Erickson K., and Gittelsohn J. ‘Cause it’s family talking to you’: Children acting as change agents for adult food and physical activity in American Indian households in the Upper Midwestern U.S.. Childhood. 2015;22(3):346-361. 2. Gadhoke P, Christiansen K, Pardilla M, Frick K, Gittelsohn J. ‘We’re changing our ways’: Women’s coping strategies for obesity risk-reducing behaviors in American Indian households. Ecol Food Nutr. 2015;54(6):583-602. 3. Trude ACB, Kharmats A, Jock B, Lee K, Liu D, Martins PA, Pardilla M, Swartz J, Gittelsohn J. Patterns of Food Consumption are Associated with Obesity, Self-Reported Diabetes and Cardiovascular Disease in Five American Indian Communities. Ecol Food Nutr. 2015;54(5):437-454. 4. Roberts EB, Fleischhacker S, Pardilla M, Truth M, Gadhoke P, Christansen P, Gittelsohn J. Self-reported physical activity among American Indian adults from two diverse regions. J Rural Health. 2015;1-10. 5. Christiansen K. H., Gadhoke, P., Pardilla, M, Gittelsohn, J. Work, Worksites, and Wellbeing among North American Indian Women: A Qualitative Study. 2017. Ethn Health. 2017 Apr 10:1-20. doi: 10.1080/13557858.2017.1313964. |
| IPD sharing plan | The dataset is unlikely to be available because the data belongs to the tribal communities in which the intervention took place. American Indians constitute a vulnerable population and research protocol, especially surrounding data sharing, is very strict in order to protect the privacy of participants and tribes. The data is held at Johns Hopkins University Bloomberg School of Public Health. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2019 | 12/09/2019 | Yes | No |
Editorial Notes
12/09/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
