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Family Eats:Cancer Prevention for Families (Family Eats)

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ClinicalTrials.gov Identifier: NCT00983840
Recruitment Status : Completed
First Posted : September 24, 2009
Last Update Posted : March 20, 2015
Sponsor:
Information provided by (Responsible Party):
Karen Cullen, Baylor College of Medicine

Tracking Information
First Submitted Date  ICMJE July 30, 2009
First Posted Date  ICMJE September 24, 2009
Last Update Posted Date March 20, 2015
Study Start Date  ICMJE September 2009
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2009)
Diet (fruit, vegetables, sweetened beverages, fat and calories) [ Time Frame: baseline, post and 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2009)
BMI [ Time Frame: baseline, post and 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Family Eats:Cancer Prevention for Families
Official Title  ICMJE Family Eats:Cancer Prevention for Families
Brief Summary Poor diets lead to weight problems, and may increase cancer risk. Cancers may develop over a long period of time, with some possibly initiating in childhood. Therefore, promoting healthy diets and preventing excess weight gain during childhood could be cancer protective. Families influence children's dietary behaviors by their actions and controlling the home food environment. The internet provides family access to interventions with the convenience of the home. An eight-session interactive web-based program promoting a healthy home food environment for African-American families with 9-12 year old daughters (Family Eats) was previously developed and tested. This study tests whether the Family Eats web program improves diet and weight outcomes among 320 African-American families with 8-12 year old children. This important study will pioneer a new channel for behavior change intervention with African-American families and holds the promise of reaching large numbers of children and their families, enabling all to adopt healthy eating behaviors and achieve energy balance and reduce cancer risks.
Detailed Description Although the burden of cancer is high among individuals of all ethnicities, ethnic differences in cancer incidence and mortality exist. African-Americans experience a higher incidence of certain cancers compared with the White population, with mortality rates at least 40% higher than other populations. Obesity, high fat, and low fruit (F) and vegetable (V) intakes increase cancer risks. Cancers may develop over a long period of time, with some possibly initiating in childhood; therefore, promoting FV and preventing excess weight gain during childhood could be cancer protective. Families influence children's dietary behaviors by direct modeling of dietary behaviors, parenting skills around food, and controlling the home food environment. However, few intervention studies have focused on family influences on dietary behaviors, particularly among ethnic minority groups which may differ in cultural and other aspects of family functioning. Unfortunately, low participation rates for community-based family interventions suggest that alternate intervention delivery systems be investigated. The internet provides family access within the convenience of the home. In a previous R21 application, the Principal Investigator developed an eight-session interactive web-based program promoting a healthy home food environment for African-American families with 9-12 year old daughters (Family Eats). Family Eats was evaluated for feasibility and changes in mediating variables were obtained. This proposal will test the efficacy of the Family Eats web program to improve FV and dietary fat behavior and weight outcomes among 320 AA families with 8-12 year old children. This important study will pioneer a new channel for behavior change intervention with African-American families and holds the promise of reaching large numbers of children and their families, enabling all to adopt healthy eating behaviors and achieve energy balance and reduce cancer risks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE Other: Family Eats
8-session web-based program on healthy eating for African American families
Study Arms  ICMJE
  • Experimental: Family Eats
    8-session program on health eating
    Intervention: Other: Family Eats
  • Active Comparator: Family eats- plain
    Family eats without role model stories and goal setting
    Intervention: Other: Family Eats
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2015)
151
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2009)
640
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • African -American families with 8-10 year old children
  • Home computer with dsl line

Exclusion Criteria:

  • Parents or children who report a medically prescribed diet, identified through a pre-screening questionnaire, will be excluded because these mothers may have received prior dietary counseling and have increased motivation for making dietary changes.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00983840
Other Study ID Numbers  ICMJE 124505-01A1
CA124505-01A1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karen Cullen, Baylor College of Medicine
Study Sponsor  ICMJE Baylor College of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karen W Cullen, DrPH Baylor College of Medicine
PRS Account Baylor College of Medicine
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP