HealthyFamily EatsNCT00983840
Family Eats:Cancer Prevention for Families
A study testing Family Eats in people with Healthy, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Family Eats
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- African -American families with 8-10 year old children
- Home computer with dsl line
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Nutrition Research Center
Houston, Texas, 77030
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Family Eats
- Keywords
- diet, African-American families, web-based
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family EatsOther
8-session web-based program on healthy eating for African American families
| Study group | Role | What they receive |
|---|---|---|
| Family Eats | Experimental | 8-session program on health eating Receives: Other: Family Eats |
| Family eats- plain | Active comparator | Family eats without role model stories and goal setting Receives: Other: Family Eats |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet (fruit, vegetables, sweetened beverages, fat and calories)
Measured: baseline, post and 6 months
Secondary outcomes (1)
BMI
Measured: baseline, post and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Cullen, Baylor College of Medicine
- Investigators
- Karen W Cullen, DrPH, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983840
- Sponsor's protocol ID
- 124505-01A1
- Other IDs
- CA124505-01A1
- Acronym
- Family Eats
- Status last verified
- Feb 2012
- First submitted
- 30 Jul 2009
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Eats:Cancer Prevention for Families
- ClinicalTrials.gov ID
- NCT00983840
- Acronym / sponsor ID
- Family Eats / 124505-01A1
- Conditions
- Healthy
- Keywords
- diet, African-American families, web-based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 24 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Eats | Experimental | Other: Family Eats8-session program on health eating |
| Family eats- plain | Active comparator | Other: Family EatsFamily eats without role model stories and goal setting |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- African -American families with 8-10 year old children
- Home computer with dsl line
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Eats8-session web-based program on healthy eating for African American families | Other | Family Eats, Family eats- plain |
Primary outcome
Diet (fruit, vegetables, sweetened beverages, fat and calories)
Time frame: baseline, post and 6 months
1 secondary outcome
BMI
Time frame: baseline, post and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen W Cullen, DrPH principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Eats in people with Healthy, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet (fruit, vegetables, sweetened beverages, fat and calories) (time frame: baseline, post and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2015.