Sedentary BehaviorNCT06674642
Traditional Indigenous Foods Diet and Health Study
A study testing Traditional Indigenous Foods diet in people with Sedentary Behavior and Physical Activity, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Physical Activity
- What is being tested?
- Traditional Indigenous Foods diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2024to 7 Apr 2025
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Indian
- Body mass index (BMI) of 18.5-42.0 kg/m2
Who cannot join
- Health condition that impairs mobility or ability to safely be physically active
- Fasting Blood glucose ≥ 126 mg/dl
- Currently taking anti-inflammatory medications
- Pregnant, breast feeding or lactating
- Currently on a regulated diet
- Currently exercising for 60 minutes or longer greater than 2 times per week
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- Allergic to any of the study foods shown in the menu and list of ingredients
- Strong aversion to any of the study foods
- Taking one of the following medications: blood thinning drugs, insulin, biologics, chemotherapy or on immune suppressant medications, and those who have started a new hyperglycemic, hypercholesterolemia, anti-depressant, anti-anxiety, or anti-psychotic medication(s) in the last two months.
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203
About this study
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.
Read the 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
- Sedentary Behavior, Physical Activity
- Being tested
- Traditional Indigenous Foods diet
- Keywords
- Traditional Indigenous foods diet, American Indians
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Indigenous Foods dietOther
A diet composed of traditional indigenous foods will be given to participants.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Indigenous Foods diet | Experimental | Participants will consume a diet comprised of traditional indigenous foods. Receives: Other: Traditional Indigenous Foods diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity as measured by Accelerometer
Activity will be measured by an accelerometer for seven days in each phase
Measured: Day 0, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start12 Sep 2024
- Primary completion7 Apr 2025
- Study completion7 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study will employ a single-subject experiment (personalized trial) approach with an ABAB design. The participants will act as their own controls. During Phase A participants will consume their usual (control) diet. During Phase B they will consume a Traditional Indigenous Foods diet provided by the GFHNRC. Randomization in single-subject designs takes the form of random assignment of treatment start times and phase lengths for each participant. Statistical analysis will consist of a mixed model that will be fit with a fixed effect of phase (A1, B1, A2, B2) and random intercept for subject for the for each item being examined.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Julie Hess, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674642
- Sponsor's protocol ID
- GFHNRC157
- Status last verified
- Apr 2025
- First submitted
- 2 Nov 2024
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Indigenous Foods Diet and Health Study
- ClinicalTrials.gov ID
- NCT06674642
- Acronym / sponsor ID
- GFHNRC157
- Conditions
- Sedentary Behavior, Physical Activity
- Keywords
- Traditional Indigenous foods diet, American Indians
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 5 Nov 2024 (actual)
- 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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will employ a single-subject experiment (personalized trial) approach with an ABAB design. The participants will act as their own controls. During Phase A participants will consume their usual (control) diet. During Phase B they will consume a Traditional Indigenous Foods diet provided by the GFHNRC. Randomization in single-subject designs takes the form of random assignment of treatment start times and phase lengths for each participant. Statistical analysis will consist of a mixed model that will be fit with a fixed effect of phase (A1, B1, A2, B2) and random intercept for subject for the for each item being examined.
| Arm | Type | Receives |
|---|---|---|
| Traditional Indigenous Foods diet | Experimental | Other: Traditional Indigenous Foods dietParticipants will consume a diet comprised of traditional indigenous foods. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Indian
- Body mass index (BMI) of 18.5-42.0 kg/m2
Key exclusion criteria (9 listed)
- Health condition that impairs mobility or ability to safely be physically active
- Fasting Blood glucose ≥ 126 mg/dl
- Currently taking anti-inflammatory medications
- Pregnant, breast feeding or lactating
- Currently on a regulated diet
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 |
|---|---|---|
| Traditional Indigenous Foods dietA diet composed of traditional indigenous foods will be given to participants. | Other | Traditional Indigenous Foods diet |
Primary outcome
Change in physical activity as measured by Accelerometer
Time frame: Day 0, Day 7
Activity will be measured by an accelerometer for seven days in each phase
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 22 Apr 2025.
- Grand Forks Human Nutrition Research Center Current Nutrition StudiesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Julie Hess, PhD principal investigator
USDA Grand Forks Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Indigenous Foods diet in people with Sedentary Behavior and Physical Activity, run by USDA Grand Forks Human Nutrition Research Center 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 2 inclusion and 9 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 22 Apr 2025. 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?
Change in physical activity as measured by Accelerometer (time frame: Day 0, Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2025.