Trials / Completed
CompletedNCT06674642
Traditional Indigenous Foods Diet and Health Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- USDA Grand Forks Human Nutrition Research Center · Federal
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this research is to determine whether eating a diet made up of Traditional Indigenous Foods from the Northern Great Plains area will spontaneously result in an increase in physical activity by American Indians, and whether the diet improves metabolic measures of health, mood and self-regulation of healthy eating and engaging in physical activity.
Detailed description
The primary aim of the current study is to determine whether consuming a healthier more Traditional Indigenous Foods diet produces non-targeted simultaneous changes in physical activity of American Indians. Coaction or dual behavior change refers to a spontaneous change in a nontargeted behavior when producing a change in a targeted behavior. A benefit of coactivation is that two healthy behaviors change when targeting just one. Physical activity was chosen as a primary non-targeted behavior because American Indians and Alaska Natives are 34% more likely to report physical inactivity than non-Hispanic Whites. Physical inactivity and sedentary behavior have negative health consequences. Chronic health conditions such as obesity, cardiovascular disease, Type 2 diabetes, and mental health disorders are more prevalent in people who are physically inactive and/or engage in greater sedentary behavior. A unique aspect of the proposed research is that it will develop a traditional indigenous foods diet based on historical research of several tribes (Mandan, Hidatsa, and Arikara (MHA) Nation, Lakota Sioux, Western and Eastern Dakota Sioux, Ojibwa, and Chippewa tribes) that lived in the Northern Great Plains. The nutrient content of the diet will be based on the 2020 Dietary Guidelines for Americans (DGA) Healthy U.S.-Style Dietary Pattern. However, because bovine dairy is not native to the U.S., alternative foods will be used to ensure adequate intake of the nutrients commonly provided by the dairy food groups. Calcium concentration of participants will be carefully monitored. This study will use a personalized trial approach that focuses on understanding individual responses of American Indians living with a heritage from the Northern Great Plains to a Traditional Indigenous Foods diet on behavioral, psychological, and clinical biochemistry outcomes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Traditional Indigenous Foods diet | A diet composed of traditional indigenous foods will be given to participants. |
Timeline
- Start date
- 2024-09-12
- Primary completion
- 2025-04-07
- Completion
- 2025-04-07
- First posted
- 2024-11-05
- Last updated
- 2025-04-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06674642. Inclusion in this directory is not an endorsement.