LifestyleNCT02211781
Study of Diets and Way of Life of Native Americans and Hispanics in New Mexico During the Time of the Trinity Nuclear Test
An observational study of Lifestyle and Diet, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: The National Cancer Institute has been studying health risks to people in New Mexico at the time of the first nuclear bomb test. This was called the Trinity nuclear test. It took place in 1945. Researchers want to also learn about Native Americans and Hispanics at that time. Read more about this study
- Who is it for?
- Ages 75 to 101 years
- Conditions the study is for
- Lifestyle, Diet, Ionizing Radiation Exposure
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2014to 21 May 2018
- Phase
- Observational
- 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 75 to 101 years
- All sexes
- No healthy volunteers
- Older adult
- Data Analysis Only
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
Official title: A Pilot Study of Dietary and Lifestyle Patterns Among Native Americans and Hispanics/Latinos in New Mexico at the Time of the Trinity Nuclear Test
Background:
- The National Cancer Institute has been studying health risks to people in New Mexico at the time of the first nuclear bomb test. This was called the Trinity nuclear test. It took place in 1945. Researchers want to also learn about Native Americans and Hispanics at that time. They want to learn about their way of life and their diets. This will give a more complete picture of the health risks to people in New Mexico in 1945.
Read more
Objectives:
- To learn about the activities and eating habits of Hispanic and tribal communities during the 1940s.
- To see if a group of Hispanic and Native Americans who were living in New Mexico in 1945 can be gathered.
Eligibility:
- Native American or Hispanic adults who were alive in 1945. They must know firsthand about the lifestyle and diet in New Mexico at that time.
Design:
- Participants will have 1 visit. They will be interviewed at a place like a library or office. They will answer questions about their lifestyle and diet around 1945. This will take up 60 90 minutes.
- Participants may agree to have their interviews taped. Their names will not be kept with their answers from the interviews.
Read the detailed description
The evaluation of health risks among the public as a consequence of exposure to radioactive fallout from nuclear testing has been an important area of research for many years by investigators in the Radiation Epidemiology Branch (REB). As a result of the reputation of this group in the field of dose and risk assessment related to radioactive fallout, and the expertise of the National Cancer Institute (NCI) in cancer research, in 2007, U.S. Senator Jeff Bingaman (D, NM) sent a request to the NCI to evaluate the health risks to New Mexico residents from the first nuclear bomb test (named Trinity) that was conducted in 1945 in south-central New Mexico. The NCI responded in early 2008 with a preliminary evaluation of the radiation doses received by the residents of New Mexico. However, the evaluation made no special provisions for lifestyles and diets of tribal community members or Hispanics\Latinos which were a significant part of the population. Little is known about Native American and Hispanic\Latino lifestyles and diets in the mid-twentieth century, yet such data are necessary to produce a credible assessment of health risks to the state s population. For this reason, REB investigators did not publish the initial dose assessment in the peer-reviewed literature. Additionally, since statewide health records cannot be reconstructed in a meaningful way to determine excess disease rates, estimation of health risks in this population can only be projected (i.e., estimated) based on the magnitude and distribution of radiation doses received and the relationships between radiation dose and cancer risks observed in other populations. Since the preparation of the 2008 report, the REB exposure assessment models used to assess doses from radioactive fallout from other nuclear test sites have been improved and published in the peer-reviewed literature. The required improvements in the 2008 Trinity assessment that would support publication of the projected health risks includes sex- and age-dependent diet and lifestyle models for Native Americans and Hispanics\Latinos in New Mexico in the mid-1940s. We are proposing a pilot study to collect, via individual interviews, information on lifestyle and diet from up to 9 key informants of Native Americans and Hispanics\Latinos living in New Mexico who were alive at the time of the bomb (currently greater than or equal to 69 years old). This data will inform the design of a larger study, which will collect lifestyle and diet information from a series of targeted focus groups. The information acquired from these 9 individual interviews will be used to 1) determine the feasibility of assembling focus groups of members of tribal and Hispanic\Latino communities in New Mexico who were alive in 1945 at the time of the bomb and 2) provide lifestyle and diet information to be used for refining focus group interviewing tools.
- Conditions
- Lifestyle, Diet, Ionizing Radiation Exposure
- Keywords
- Tribal Communities, Radiation, Cancer
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet and Lifestyle
Measured: September 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study start1 Aug 2014
- Primary completion1 Aug 2014
- Study completion21 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LifestyleStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Steven L Simon, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211781
- Sponsor's protocol ID
- 999914162
- Other IDs
- 14-C-N162
- Status last verified
- 21 May 2018
- First submitted
- 6 Aug 2014
- Last updated
- 23 May 2018
- Results posted
- No
Publications
Hellman A, Weislow OS, Twardzik DR, Fowler AK. Type C retrovirus activation and possible functions in the normal and tumor-bearing host. Cancer Res. 1979 Jul;39(7 Pt 2):2902-7.
PubMed 221111Schwerin M, Schonfeld S, Drozdovitch V, Akimzhanov K, Aldyngurov D, Bouville A, Land C, Luckyanov N, Mabuchi K, Semenova Y, Simon S, Tokaeva A, Zhumadilov Z, Potischman N. The utility of focus group interviews to capture dietary consumption data in the distant past: dairy consumption in Kazakhstan villages 50 years ago. J Dev Orig Health Dis. 2010 Jun;1(3):192-202. doi: 10.1017/S2040174410000243.
PubMed 24286002
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Dietary and Lifestyle Patterns Among Native Americans and Hispanics/Latinos in New Mexico at the Time of the Trinity Nuclear Test
- ClinicalTrials.gov ID
- NCT02211781
- Acronym / sponsor ID
- 999914162
- Conditions
- Lifestyle, Diet, Ionizing Radiation Exposure
- Keywords
- Tribal Communities, Radiation, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Aug 2014
- Primary completion
- 1 Aug 2014 (actual)
- Study completion
- 21 May 2018 (actual)
- First posted
- 7 Aug 2014 (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.
Background:
- The National Cancer Institute has been studying health risks to people in New Mexico at the time of the first nuclear bomb test. This was called the Trinity nuclear test. It took place in 1945. Researchers want to also learn about Native Americans and Hispanics at that time. They want to learn about their way of life and their diets. This will give a more complete picture of the health risks to people in New Mexico in 1945.
Objectives:
- To learn about the activities and eating habits of Hispanic and tribal communities during the 1940s.
- To see if a group of Hispanic and Native Americans who were living in New Mexico in 1945 can be gathered.
Eligibility:
- Native American or Hispanic adults who were alive in 1945. They must know firsthand about the lifestyle and diet in New Mexico at that time.
Design:
- Participants will have 1 visit. They will be interviewed at a place like a library or office. They will answer questions about their lifestyle and diet around 1945. This will take up 60 90 minutes.
- Participants may agree to have their interviews taped. Their names will not be kept with their answers from the interviews.
Detailed description
The evaluation of health risks among the public as a consequence of exposure to radioactive fallout from nuclear testing has been an important area of research for many years by investigators in the Radiation Epidemiology Branch (REB). As a result of the reputation of this group in the field of dose and risk assessment related to radioactive fallout, and the expertise of the National Cancer Institute (NCI) in cancer research, in 2007, U.S. Senator Jeff Bingaman (D, NM) sent a request to the NCI to evaluate the health risks to New Mexico residents from the first nuclear bomb test (named Trinity) that was conducted in 1945 in south-central New Mexico. The NCI responded in early 2008 with a preliminary evaluation of the radiation doses received by the residents of New Mexico. However, the evaluation made no special provisions for lifestyles and diets of tribal community members or Hispanics\Latinos which were a significant part of the population. Little is known about Native American and Hispanic\Latino lifestyles and diets in the mid-twentieth century, yet such data are necessary to produce a credible assessment of health risks to the state s population. For this reason, REB investigators did not publish the initial dose assessment in the peer-reviewed literature. Additionally, since statewide health records cannot be reconstructed in a meaningful way to determine excess disease rates, estimation of health risks in this population can only be projected (i.e., estimated) based on the magnitude and distribution of radiation doses received and the relationships between radiation dose and cancer risks observed in other populations. Since the preparation of the 2008 report, the REB exposure assessment models used to assess doses from radioactive fallout from other nuclear test sites have been improved and published in the peer-reviewed literature. The required improvements in the 2008 Trinity assessment that would support publication of the projected health risks includes sex- and age-dependent diet and lifestyle models for Native Americans and Hispanics\Latinos in New Mexico in the mid-1940s. We are proposing a pilot study to collect, via individual interviews, information on lifestyle and diet from up to 9 key informants of Native Americans and Hispanics\Latinos living in New Mexico who were alive at the time of the bomb (currently greater than or equal to 69 years old). This data will inform the design of a larger study, which will collect lifestyle and diet information from a series of targeted focus groups. The information acquired from these 9 individual interviews will be used to 1) determine the feasibility of assembling focus groups of members of tribal and Hispanic\Latino communities in New Mexico who were alive in 1945 at the time of the bomb and 2) provide lifestyle and diet information to be used for refining focus group interviewing tools.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Ages
- 75 to 101 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diet and Lifestyle
Time frame: September 2014
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 23 May 2018.
- Background: PubMed 221111Hellman A, Weislow OS, Twardzik DR, Fowler AK. Type C retrovirus activation and possible functions in the normal and tumor-bearing host. Cancer Res. 1979 Jul;39(7 Pt 2):2902-7.
- Background: PubMed 24286002Schwerin M, Schonfeld S, Drozdovitch V, Akimzhanov K, Aldyngurov D, Bouville A, Land C, Luckyanov N, Mabuchi K, Semenova Y, Simon S, Tokaeva A, Zhumadilov Z, Potischman N. The utility of focus group interviews to capture dietary consumption data in the distant past: dairy consumption in Kazakhstan villages 50 years ago. J Dev Orig Health Dis. 2010 Jun;1(3):192-202. doi: 10.1017/S2040174410000243.
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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.
Steven L Simon principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lifestyle and Diet, run by National Cancer Institute (NCI) 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?
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 23 May 2018. 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?
Diet and Lifestyle (time frame: September 2014). 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 NCT02211781, which also lists 2 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 23 May 2018.