MethylationNCT01517139
Diet and Nutrition Pilot Study for Chinese Adolescents and Their Mothers
An observational study of Methylation and Body Composition, run by National Cancer Institute (NCI) at 1 site in China.
Trial summary
Background: Researchers want to collect information on diet, physical activity, and sun exposure in children and young adults. The data can provide information on the effect these factors might have on the development of cancer and other diseases. Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Methylation, Body Composition, Physical Activity
- How many people
- 278 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2012to 27 Aug 2013
- 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 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This is a pilot study of approximately 200 children and their mothers who had participated in a prior study of 247,000 mother-child pairs in 1993 to 1995. The aim of the pilot is to assess the feasibility of finding the subjects, assessing participation rates, and testing instruments to measure diet, physical activity and ultraviolet radiation exposure. Participants were identified from records documenting location of residence in the previous study. They were approached by local medical staff to assess interest in participation for the pilot study. The study involved 8 days of data collection as well as saliva and blood collection. Results from the local hospital blood tests and the research sample were provided to the participants by the local medical staff. Follow-up of the larger cohort would be based on successful study protocol components or improved versions of the instruments or logistics.
Who may be able to join
- Pairs of mothers and their children 15 - 17 years of age who completed Task1 and who agree to participate in the study (Task2 ).
Who cannot join
- Maternal pill usage only after conception and those who may have stopped taking folic acid pills before the second trimester.
- Pairs of mothers and children where the mother is not the primary guardian (e.g., mother died or never lived with the child).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Test the Methods for the Diet, Nutrition and Physical Activity Feasibility Study of Early Life Determinants of Adult Cancers in a Chinese Cohort of Adolescents and Their Mothers
Background:
- Researchers want to collect information on diet, physical activity, and sun exposure in children and young adults. The data can provide information on the effect these factors might have on the development of cancer and other diseases. Information collected only from adults does not accurately measure these factors. To collect more accurate information, both mothers and children will provide information. Study participants will be from Hebei province in northeastern China and Jiangsu province in eastern China.
Read more
Objectives:
- To collect and study diet, activity, and sun exposure data from Chinese adolescents and their mothers.
Eligibility:
- Adolescents between 15 and 17 years of age from Hebei and Jiangsu provinces in China.
- Mothers of the study adolescents.
Design:
- Participants will answer questions about their diet, physical activity, and time in the sun.
- Participants will wear a pedometer to measure activity for 7 days. They will also wear a badge to measure sun exposure for 3 days.
- Participants will record their activities and food and drinks consumed for 3 days. Urine samples will be collected for a full day.
- Participants will have a grip strength test. On the last day of the study, they will provide blood, saliva, and toenail samples.
- A smaller separate group of adolescents will provide saliva samples only and complete a food questionnaire.
Read the detailed description
Background:
Emerging epidemiological evidence suggests that early-life exposures in conjunction with genetic makeup and variability may be important in the etiology of many common adult cancers. Prospectively collected information on adolescent and early adulthood exposures is lacking and current evidence often relies on adult recall of the past with a limited array of exposure variables.
Long Term Objective:
- To investigate the feasibility of assessing exposures that may be linked to early life exposures and to later diseases. Exposures include diet, physical activity, UV-exposure, DNAmethylation status, body size and reproductive factors. This feasibility work will inform additional research in an existing large Chinese-U.S. CDC collaborative project conducted in 1993 - 1995, the Community Intervention Program (CIP) (n = 247,000). Short Term Objectives:
- To determine the feasibility of collecting and assessing the quality of data on current diet, nutritional status, physical activity, physical strength, UV exposure, DNA methylation status and other environmental exposures as early life determinants of adult cancer in adolescents 15 - 17 years of age and early adulthood in their mothers.
- To assess differences in methylation status of DNA between those exposed to periconceptional folic acid supplementation and those unexposed.
- To compare dietary and physical activity self-reporting instruments against objective measures of dietary intake and physical activity, respectively.
Eligibility:
Pairs of mothers and their children aged 15-17 years from the CIP, who completed an associated pilot study in Laoting (Task 1), Hebei provincein the North, and Taicang, Jiangsu provincein the South, and who agree to participate in the study. An additional subsample of 100 children who completed an accompanying study (Task 1), who agree to participate in a sub-study will be eligible.
Design:
This pilot study will include 100 pairs of children and their mothers recruited from 2 provinces. A total of 50 children (aged 16-17years) from a high school (grades 9-10) will be identified in each province. To the extent possible, approximately equal numbers of children aged 16 and 17 years of age will be recruited, stratified by gender and in utero exposure to folic acid. An additional sub-sample of 100 children that completed an accompanying study (Task 1) will be enrolled for only saliva collection and completion of a food frequency questionnaire.
- Conditions
- Methylation, Body Composition, Physical Activity, Puberty
- Keywords
- Diet and Nutrition, Pregnancy Folic Acid, In Utero Exposure, DNA Methylation, Physical Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Feasibility Cohort | 100 pairs of children and their mothers recruited from 2 provinces. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rates >60%
Participation rates were 66% in the rural community and 87% in the urban community.
Measured: At the end of the study, July 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study start1 Mar 2012
- Primary completion31 Jul 2012
- Study completion27 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MethylationStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Nancy A. Potischman, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517139
- Sponsor's protocol ID
- 999912038
- Other IDs
- 12-C-N038
- Status last verified
- Mar 2020
- First submitted
- 24 Jan 2012
- Last updated
- 3 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Test the Methods for the Diet, Nutrition and Physical Activity Feasibility Study of Early Life Determinants of Adult Cancers in a Chinese Cohort of Adolescents and Their Mothers
- ClinicalTrials.gov ID
- NCT01517139
- Acronym / sponsor ID
- 999912038
- Conditions
- Methylation, Body Composition, Physical Activity, Puberty
- Keywords
- Diet and Nutrition, Pregnancy Folic Acid, In Utero Exposure, DNA Methylation, Physical Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Mar 2012 (actual)
- Primary completion
- 31 Jul 2012 (actual)
- Study completion
- 27 Aug 2013 (actual)
- First posted
- 25 Jan 2012 (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:
- Researchers want to collect information on diet, physical activity, and sun exposure in children and young adults. The data can provide information on the effect these factors might have on the development of cancer and other diseases. Information collected only from adults does not accurately measure these factors. To collect more accurate information, both mothers and children will provide information. Study participants will be from Hebei province in northeastern China and Jiangsu province in eastern China.
Objectives:
- To collect and study diet, activity, and sun exposure data from Chinese adolescents and their mothers.
Eligibility:
- Adolescents between 15 and 17 years of age from Hebei and Jiangsu provinces in China.
- Mothers of the study adolescents.
Design:
- Participants will answer questions about their diet, physical activity, and time in the sun.
- Participants will wear a pedometer to measure activity for 7 days. They will also wear a badge to measure sun exposure for 3 days.
- Participants will record their activities and food and drinks consumed for 3 days. Urine samples will be collected for a full day.
- Participants will have a grip strength test. On the last day of the study, they will provide blood, saliva, and toenail samples.
- A smaller separate group of adolescents will provide saliva samples only and complete a food questionnaire.
Detailed description
Background:
Emerging epidemiological evidence suggests that early-life exposures in conjunction with genetic makeup and variability may be important in the etiology of many common adult cancers. Prospectively collected information on adolescent and early adulthood exposures is lacking and current evidence often relies on adult recall of the past with a limited array of exposure variables.
Long Term Objective:
- To investigate the feasibility of assessing exposures that may be linked to early life exposures and to later diseases. Exposures include diet, physical activity, UV-exposure, DNAmethylation status, body size and reproductive factors. This feasibility work will inform additional research in an existing large Chinese-U.S. CDC collaborative project conducted in 1993 - 1995, the Community Intervention Program (CIP) (n = 247,000). Short Term Objectives:
- To determine the feasibility of collecting and assessing the quality of data on current diet, nutritional status, physical activity, physical strength, UV exposure, DNA methylation status and other environmental exposures as early life determinants of adult cancer in adolescents 15 - 17 years of age and early adulthood in their mothers.
- To assess differences in methylation status of DNA between those exposed to periconceptional folic acid supplementation and those unexposed.
- To compare dietary and physical activity self-reporting instruments against objective measures of dietary intake and physical activity, respectively.
Eligibility:
Pairs of mothers and their children aged 15-17 years from the CIP, who completed an associated pilot study in Laoting (Task 1), Hebei provincein the North, and Taicang, Jiangsu provincein the South, and who agree to participate in the study. An additional subsample of 100 children who completed an accompanying study (Task 1), who agree to participate in a sub-study will be eligible.
Design:
This pilot study will include 100 pairs of children and their mothers recruited from 2 provinces. A total of 50 children (aged 16-17years) from a high school (grades 9-10) will be identified in each province. To the extent possible, approximately equal numbers of children aged 16 and 17 years of age will be recruited, stratified by gender and in utero exposure to folic acid. An additional sub-sample of 100 children that completed an accompanying study (Task 1) will be enrolled for only saliva collection and completion of a food frequency questionnaire.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feasibility Cohort | – | –100 pairs of children and their mothers recruited from 2 provinces. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This is a pilot study of approximately 200 children and their mothers who had participated in a prior study of 247,000 mother-child pairs in 1993 to 1995. The aim of the pilot is to assess the feasibility of finding the subjects, assessing participation rates, and testing instruments to measure diet, physical activity and ultraviolet radiation exposure. Participants were identified from records documenting location of residence in the previous study. They were approached by local medical staff to assess interest in participation for the pilot study. The study involved 8 days of data collection as well as saliva and blood collection. Results from the local hospital blood tests and the research sample were provided to the participants by the local medical staff. Follow-up of the larger cohort would be based on successful study protocol components or improved versions of the instruments or logistics.
Key inclusion criteria (1 listed)
- Pairs of mothers and their children 15 - 17 years of age who completed Task1 and who agree to participate in the study (Task2 ).
Key exclusion criteria (2 listed)
- Maternal pill usage only after conception and those who may have stopped taking folic acid pills before the second trimester.
- Pairs of mothers and children where the mother is not the primary guardian (e.g., mother died or never lived with the child).
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
Participation rates >60%
Time frame: At the end of the study, July 2012
Participation rates were 66% in the rural community and 87% in the urban community.
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 3 Mar 2020.
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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.
Nancy A. Potischman, Ph.D. 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 Methylation and Body Composition, run by National Cancer Institute (NCI) at 1 site in China.
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 1 inclusion and 2 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 3 Mar 2020. 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 China. 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?
Participation rates >60% (time frame: At the end of the study, July 2012). 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 3 Mar 2020.