NCT00528762

Brief Summary

Primary Objective: For focus groups of Mexican American and African-American girls and focus groups of their parents to explore factors that could enhance the conduct of a future study of puberty and body mass. Specifically these focus groups will address:

  • Whether clinical assessment of pubertal staging is acceptable.
  • How to enhance cooperation by parents and their daughters of different socioeconomic groups, among families with different levels of acculturation, and girls of different body mass indices.
  • Explore whether established questionnaire items about puberty, that have been used in traditional surveys, require culture-specific changes to improve exposure assessment.
  • Explore the acceptability of self-reported pictograms for body image and for developmental assessment by girls.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

1.4 years

First QC Date

September 11, 2007

Last Update Submit

July 26, 2012

Conditions

Healthy

Keywords

EpidemiologyPubertyBody WeightBody ImageFocus Group

Outcome Measures

Primary Outcomes (1)

  • Exploratory Results from Mexican and African American Family Focus Groups on Puberty

    2 Years

Study Arms (1)

Focus Group

Mexican American or African American females (aged 6-12 years old) and their parents

Behavioral: Focus Group

Interventions

Focus GroupBEHAVIORAL

Focus group discussion about puberty and body image lasting 1 1/2 hours.

Focus Group

Eligibility Criteria

Age6 Years - 12 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Participants are females aged 6-12 years old that are of Mexican American or African American descent and their parents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.T. M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Body Weight

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Michele Forman, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2007

First Posted

September 12, 2007

Study Start

November 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations

US(1)