- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00983840
Family Eats:Cancer Prevention for Families (Family Eats)
March 18, 2015 updated by: Karen Cullen, Baylor College of Medicine
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.
Study Overview
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
Interventional
Enrollment (Actual)
151
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Children's Nutrition Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 10 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Family Eats
8-session program on health eating
|
8-session web-based program on healthy eating for African American families
|
|
Active Comparator: Family eats- plain
Family eats without role model stories and goal setting
|
8-session web-based program on healthy eating for African American families
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Diet (fruit, vegetables, sweetened beverages, fat and calories)
Time Frame: baseline, post and 6 months
|
baseline, post and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
BMI
Time Frame: baseline, post and 6 months
|
baseline, post and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Karen W Cullen, DrPH, Baylor College of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
July 30, 2009
First Submitted That Met QC Criteria
September 22, 2009
First Posted (Estimate)
September 24, 2009
Study Record Updates
Last Update Posted (Estimate)
March 20, 2015
Last Update Submitted That Met QC Criteria
March 18, 2015
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 124505-01A1
- CA124505-01A1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.