Diet and Nutrition Pilot Study for Chinese Adolescents and Their Mothers

Physical Activity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01517139
• Other study ID #: 999912038
• Secondary ID: 12-C-N038
• Status: Completed
• Start date: March 1, 2012
• Est. completion date: August 27, 2013

Study information

• Verified date: March 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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, 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:

2. 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: August 27, 2013
• Est. primary completion date: July 31, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 45 Years

Eligibility

• INCLUSION 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 where the mother is not the primary guardian (e.g., mother died or never lived with the child).

Related Conditions & MeSH terms

• Body Composition
• Methylation
• Physical Activity
• Puberty

Locations

Country	Name	City	State
China	Chinese Center for Disease Contron & Prevention	Bejing

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation rates >60%	Participation rates were 66% in the rural community and 87% in the urban community.	At the end of the study, July 2012