Diet and Nutrition Pilot Study for Chinese Adolescents and Their Mothers

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01517139
First received: January 24, 2012
Last updated: August 15, 2014
Last verified: August 2013
  Purpose

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.

Condition
In Utero Exposure

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Changes in DNA Methylation related to in utero or pregnancy folate exposure.

Estimated Enrollment: 360
Study Start Date: December 2011
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:

  1. 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, DNA methylation status, body size and reproductive factors. This feasibility work will inform additional research in an existing large Chinese-U.SC.D C collaborative project conducted in 1993- 1995, Community Intervention Program( ClP)( n = 247,OOO).

    Short Term Objectives:

  2. To determine the feasibility of collecting and assess in 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 adolescent 15 - 17 years of age and early adulthood in their mothers.
  3. To assess differences in methylation status of DNA between those exposed to periconceptional folic acid supplementation and those unexposed.
  4. 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 ClP, who completed an associated pilot study in Laoting (Task1), Hebei province in the North, and Taicang, Jiangsu province in the South, and who agree to participate in the study. An additional subsample of 100 children who completed an accompanying study (Task1), 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, 25 children (aged 15 years) from a middle school (grade 8) and 25 children (aged 16-17 years) from a high school (grades 9 -10) will be identified in each province. To the extent possible, approximately equal numbers of children of 15, 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 (Task1) will be enrolled for only saliva collection and completion of a food frequency questionnaire.

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • NCLUSION CRITERIA:

Pairs of mothers and their children 15 - 17 years of age who completed Task1 and who agree to participate in the study( Task2 ).

EXCLUSION CRITERIA:

  1. Maternal pill usage only after conception and those who may have stopped taking folic acid pills before the second trimester.
  2. Pairs of mothers and children not living together or where the mother is not the primary guardian (e.g., mother died or never lived with the child). Children in boarding schools will not be included.
  3. Participants taking sulfa drugs (sulfonamides) as these drugs may interfere with para-aminobenzoic acid (PABA), which will be used as a marker for 24-hour urine collection.
  4. History of allergy to sunscreen, which may indicate possible allergy to PABA. Due to its UVB absorbing properties, PABA has been used as a component in sunscreen preparations, especially in the past.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517139

Locations
China
Chinese Center for Disease Contron & Prevention
Bejing, China
Sponsors and Collaborators
Investigators
Principal Investigator: Nancy A. Potischman, Ph.D. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01517139     History of Changes
Other Study ID Numbers: 999912038, 12-C-N038
Study First Received: January 24, 2012
Last Updated: August 15, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Diet and Nutrition
Pregnancy Folate
In Utero Exposure
DNA Methylation
Physical Activity

ClinicalTrials.gov processed this record on August 21, 2014