Diet and Nutrition Pilot Study for Chinese Adolescents and Their Mothers

NCT01517139 | Completed

• 2 other identifiers: 99991203812-C-N038
• Study Type: observational
• Target: 278
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Methylation; Body Composition; Physical Activity; Puberty

Keywords

Diet and Nutrition; Pregnancy Folic Acid; In Utero Exposure; DNA Methylation; Physical Activity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Feasibility Cohort

100 pairs of children and their mothers recruited from 2 provinces.

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Chinese Center for Disease Contron & Prevention

Beijing, China

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Nancy A. Potischman, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: January 25, 2012
• Study Start: March 1, 2012
• Primary Completion: July 31, 2012
• Study Completion: August 27, 2013
• Last Updated: March 3, 2020

Record last verified: 2020-03

Locations

CN (1)