ObesityNCT00224887
Family-Based Nutrition Intervention for Latino Children
A study testing In home nutrition counseling and standard nutrition education curriculum in people with Obesity and Heart Diseases, run by Stanford University.
Trial summary
Primary Hypothesis Children whose mothers receive the FBC sessions will have significantly lower BMI one year after the intervention compared to control group children whose families receive an active placebo control. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Obesity, Heart Diseases
- What is being tested?
- In home nutrition counseling and standard nutrition education curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Jul 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 9 years
- All sexes
- No healthy volunteers
- Child
The inclusion criteria for the study are:
- Ethnicity: Mother is of Mexican descent and identifies with the Mexican-American community.
- Age: Child is between 6 and 9 years 11.9 months old.
- Family lives in the San Jose area
- Family does not plan to move out of the area within the next 12 months.
The exclusion criteria for the study are:
- Metabolic disease/syndrome associated with obesity.
- Diabetes
- Chronic gastro-intestinal disease
- Chronic renal disease
- Heart disease
- Eating disorders
- Aids/HIV infection
- Use of steroids
- Use of insulin injections
- Use of oral antidiabetic agents
- Use of thyroid hormones
- Use of growth hormones
- Other diseases or use of other medications that may impact growth based on Dr. Mendoza's assessment.
- Family shares food with 2 other families with children under the age of 12.
About this study
Primary Hypothesis Children whose mothers receive the FBC sessions will have significantly lower BMI one year after the intervention compared to control group children whose families receive an active placebo control.
Secondary Hypotheses In families that receive the FBC, household availability of fruits and vegetables will increase, and availability of high fat foods will decrease, as measured by multiple household food inventories, compared to control group families exposed to an active placebo intervention.
Household level of food security, mothers' food purchase motives and family food interaction will influence the effects of the FBC on household food supplies.
Read the detailed description
BACKGROUND:
Cardiovascular disease accounted for 40.6% of deaths in the United States in 1998. Although CVD does not manifest until adulthood, risk factors for CVD, such as obesity, may develop in childhood and persist into adulthood. We propose to test the efficacy of an intervention designed to prevent obesity in low-income, Mexican American children. Mexican-American children are more obese than other minority groups in the U.S. population, and are the fastest growing minority group in the U.S.A. Poor dietary practices, especially food habits that are acquired as families acculturate to the American food supply, are thought to be associated with children's excess weight gain.
We propose to conduct a randomized clinical trial in which 150 families receive family-based behavioral counseling (FBC) sessions and 150 families receive an active placebo control intervention. Mothers and their second or third grade children from sixteen low-wealth elementary schools will be randomized into either the treatment or control interventions. The purpose of the FBC sessions is to change children's food environment. Specifically, we intend to increase the amount of fruit and vegetables, and decrease the amount of high fat foods available to children in their homes. In addition, we will encourage parents to model healthy dietary practices for their children. Two intervention strategies, a video, "What's to Eat?" developed for this population and photographs of each family's food practices, taken by family members, will be used in the counseling sessions. The control intervention will consist of group sessions using a curriculum that adapts standard nutrition recommendations for traditional Mexican-American foods. Community health advisors will conduct both the FBC and control sessions. The primary outcome of the trial is children's BMI. The secondary outcome is household food supplies. We hypothesize that within a one year timeframe, children's whose mothers are exposed to the FBC will have lower BMI's compared to children whose mothers receive the active placebo control intervention. The mechanism through which we intend to change weight status is altering the type of foods available to children in their homes. Therefore, two household food inventories, one collected prior to and one after the family's payday will be used as secondary outcomes. In addition, mothers' reports of household food security level, food purchase motives, and family food interaction will be collected as covariates. Measurements will be collected within one month of completing the interventions and at six months and one year follow-up.
DESIGN NARRATIVE:
Family Based Counseling. Community health advisors visit mothers who are randomly assigned to the FBC sessions once a month, for six months, in their homes. During the first session, mothers watch the video, "What's to Eat?" with the CHA and discuss food related parenting issues. In the subsequent five sessions, photographs of the family's food habits, taken by mothers, are used as visual aids for the intervention sessions. In addition, at each session, the CHA provides mothers with a food sample related to their dietary change goal. Examples of the types of foods provided to families include fat free milk, cooking oil spray, fruits and vegetables or low fat yogurt.
Group Based Nutrition Sessions Families assigned to the group sessions are invited to one group session a month for six months. Group sessions are held in the morning and the evening to accommodate mothers' schedules. The groups sessions are based on a standard Mexican-American nutrition curriculum. This curriculum consists of a video and five lesson plans based on the USDA Food Guide Pyramid that emphasize foods indigenous to the Mexican diet. In addition to lessons from the curriculum, nutrition games, based on popular game shows such as "Nutrition Jeopardy" and "Family Feud" are also played during the sessions.
Primary Outcome Measure - Children's Weight Status Height \& Weight: Standing height will be measured twice, to the nearest millimeter, using a portable direct reading stadiometer. If the two measures differ by more than 5 mm, a third measure will be obtained. Body weight will be measured twice, to the nearest 0.1 kg, using digital scales with subjects wearing light indoor clothing without shoes. If the two measures differ by more than 0.2 kg, a third measure will be obtained. The mean of the two measures, or the median of three measures, are used to calculate BMI.
Secondary Outcome Variable Our intervention is designed to prevent obesity in children by changing their food environments. Therefore, the secondary outcome for this research is changes in the type of food available to children in their homes. Specifically, a, quantitative household food inventory that assess the actual amount of fruit, vegetables, high fat foods and total food energy is collected. Inventories are collected within three days of grocery shopping. Two trained research assistants conduct each inventory, which require approximately 15 to 60 minutes to complete. All foods except spices, hot sauces, baking powder, baking soda, coffee, tea and spoiled foods are collected in the inventories. The amounts listed on the label of packaged, canned, or frozen foods are recorded, and if opened, the proportion remaining in the package is recorded. The amount of meat or cheese is recorded in pounds based on the package label. The number of fresh fruits, vegetables and eggs are counted. Beverages are recorded in fluid ounces or gallons. Prepared foods on the stove or leftover in the refrigerator are estimated in cups.
Mothers' Socio-environment Measurements Demographics: Demographic variables, including household composition, who in the household shares the same food supplies, and where mothers purchase or receive food supplies (including WIC or food donations) will be collected from the mothers. To examine the variability in household food supplies relative to pay day, mothers will also report when their family receives pay checks. Children's demographic variables will include gender, age, and grade level.
Household Level of Food Security: Food security is defined as people's assured access to enough acceptable food, that is acquired in socially acceptable ways, for an active and healthy life. This construct will be measured using the 18 item U.S.D.A. Core Food Security Module (FSM). This instrument conceptualizes food security as consisting of four components: 1) quantity of food, 2) quality of food, 3) food anxiety and 4) food acquisition in socially acceptable ways (166, 167). Households are categorized into four levels of food insecurity: 1) food secure, 2) food insecure without hunger, 3) food insecure with moderate hunger and 4) food insecure with severe hunger (i.e., children's food intake is restricted).
- Conditions
- Obesity, Heart Diseases
- Being tested
- In home nutrition counseling, standard nutrition education curriculum
- Medical subject headings
- Obesity, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In home nutrition counselingBehavioural
In home family-based behavioral counseling
standard nutrition education curriculumOther
video and lesson plans based on USDA Food Guide Pyramid
| Study group | Role | What they receive |
|---|---|---|
| in home nutrition counseling | Experimental | In-home family-based behavioral counseling using in-person and video interventions delivered by community health advisors Receives: Behavioral: In home nutrition counseling |
| standard nutrition education curriculum | Active comparator | standard nutrition education curriculum consisting of video and lesson plans based on USDA Food Guide pyramid Receives: Other: standard nutrition education curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Body Mass Index (BMI)
child's Body Mass Index
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224887
- Sponsor's protocol ID
- 320
- Other IDs
- R01HL070218
- Status last verified
- Apr 2021
- First submitted
- 21 Sep 2005
- Last updated
- 4 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Based Nutrition Intervention for Latino Children
- ClinicalTrials.gov ID
- NCT00224887
- Acronym / sponsor ID
- 320
- Conditions
- Obesity, Heart Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2003
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 23 Sep 2005 (estimated)
- Results
- Posted 4 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Hypothesis Children whose mothers receive the FBC sessions will have significantly lower BMI one year after the intervention compared to control group children whose families receive an active placebo control.
Secondary Hypotheses In families that receive the FBC, household availability of fruits and vegetables will increase, and availability of high fat foods will decrease, as measured by multiple household food inventories, compared to control group families exposed to an active placebo intervention.
Household level of food security, mothers' food purchase motives and family food interaction will influence the effects of the FBC on household food supplies.
Detailed description
BACKGROUND:
Cardiovascular disease accounted for 40.6% of deaths in the United States in 1998. Although CVD does not manifest until adulthood, risk factors for CVD, such as obesity, may develop in childhood and persist into adulthood. We propose to test the efficacy of an intervention designed to prevent obesity in low-income, Mexican American children. Mexican-American children are more obese than other minority groups in the U.S. population, and are the fastest growing minority group in the U.S.A. Poor dietary practices, especially food habits that are acquired as families acculturate to the American food supply, are thought to be associated with children's excess weight gain.
We propose to conduct a randomized clinical trial in which 150 families receive family-based behavioral counseling (FBC) sessions and 150 families receive an active placebo control intervention. Mothers and their second or third grade children from sixteen low-wealth elementary schools will be randomized into either the treatment or control interventions. The purpose of the FBC sessions is to change children's food environment. Specifically, we intend to increase the amount of fruit and vegetables, and decrease the amount of high fat foods available to children in their homes. In addition, we will encourage parents to model healthy dietary practices for their children. Two intervention strategies, a video, "What's to Eat?" developed for this population and photographs of each family's food practices, taken by family members, will be used in the counseling sessions. The control intervention will consist of group sessions using a curriculum that adapts standard nutrition recommendations for traditional Mexican-American foods. Community health advisors will conduct both the FBC and control sessions. The primary outcome of the trial is children's BMI. The secondary outcome is household food supplies. We hypothesize that within a one year timeframe, children's whose mothers are exposed to the FBC will have lower BMI's compared to children whose mothers receive the active placebo control intervention. The mechanism through which we intend to change weight status is altering the type of foods available to children in their homes. Therefore, two household food inventories, one collected prior to and one after the family's payday will be used as secondary outcomes. In addition, mothers' reports of household food security level, food purchase motives, and family food interaction will be collected as covariates. Measurements will be collected within one month of completing the interventions and at six months and one year follow-up.
DESIGN NARRATIVE:
Family Based Counseling. Community health advisors visit mothers who are randomly assigned to the FBC sessions once a month, for six months, in their homes. During the first session, mothers watch the video, "What's to Eat?" with the CHA and discuss food related parenting issues. In the subsequent five sessions, photographs of the family's food habits, taken by mothers, are used as visual aids for the intervention sessions. In addition, at each session, the CHA provides mothers with a food sample related to their dietary change goal. Examples of the types of foods provided to families include fat free milk, cooking oil spray, fruits and vegetables or low fat yogurt.
Group Based Nutrition Sessions Families assigned to the group sessions are invited to one group session a month for six months. Group sessions are held in the morning and the evening to accommodate mothers' schedules. The groups sessions are based on a standard Mexican-American nutrition curriculum. This curriculum consists of a video and five lesson plans based on the USDA Food Guide Pyramid that emphasize foods indigenous to the Mexican diet. In addition to lessons from the curriculum, nutrition games, based on popular game shows such as "Nutrition Jeopardy" and "Family Feud" are also played during the sessions.
Primary Outcome Measure - Children's Weight Status Height \& Weight: Standing height will be measured twice, to the nearest millimeter, using a portable direct reading stadiometer. If the two measures differ by more than 5 mm, a third measure will be obtained. Body weight will be measured twice, to the nearest 0.1 kg, using digital scales with subjects wearing light indoor clothing without shoes. If the two measures differ by more than 0.2 kg, a third measure will be obtained. The mean of the two measures, or the median of three measures, are used to calculate BMI.
Secondary Outcome Variable Our intervention is designed to prevent obesity in children by changing their food environments. Therefore, the secondary outcome for this research is changes in the type of food available to children in their homes. Specifically, a, quantitative household food inventory that assess the actual amount of fruit, vegetables, high fat foods and total food energy is collected. Inventories are collected within three days of grocery shopping. Two trained research assistants conduct each inventory, which require approximately 15 to 60 minutes to complete. All foods except spices, hot sauces, baking powder, baking soda, coffee, tea and spoiled foods are collected in the inventories. The amounts listed on the label of packaged, canned, or frozen foods are recorded, and if opened, the proportion remaining in the package is recorded. The amount of meat or cheese is recorded in pounds based on the package label. The number of fresh fruits, vegetables and eggs are counted. Beverages are recorded in fluid ounces or gallons. Prepared foods on the stove or leftover in the refrigerator are estimated in cups.
Mothers' Socio-environment Measurements Demographics: Demographic variables, including household composition, who in the household shares the same food supplies, and where mothers purchase or receive food supplies (including WIC or food donations) will be collected from the mothers. To examine the variability in household food supplies relative to pay day, mothers will also report when their family receives pay checks. Children's demographic variables will include gender, age, and grade level.
Household Level of Food Security: Food security is defined as people's assured access to enough acceptable food, that is acquired in socially acceptable ways, for an active and healthy life. This construct will be measured using the 18 item U.S.D.A. Core Food Security Module (FSM). This instrument conceptualizes food security as consisting of four components: 1) quantity of food, 2) quality of food, 3) food anxiety and 4) food acquisition in socially acceptable ways (166, 167). Households are categorized into four levels of food insecurity: 1) food secure, 2) food insecure without hunger, 3) food insecure with moderate hunger and 4) food insecure with severe hunger (i.e., children's food intake is restricted).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| in home nutrition counseling | Experimental | Behavioral: In home nutrition counselingIn-home family-based behavioral counseling using in-person and video interventions delivered by community health advisors |
| standard nutrition education curriculum | Active comparator | Other: standard nutrition education curriculumstandard nutrition education curriculum consisting of video and lesson plans based on USDA Food Guide pyramid |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| In home nutrition counselingIn home family-based behavioral counseling | Behavioural | in home nutrition counseling |
| standard nutrition education curriculumvideo and lesson plans based on USDA Food Guide Pyramid | Other | standard nutrition education curriculum |
Primary outcome
Mean Change in Body Mass Index (BMI)
Time frame: 12 months
child's Body Mass Index
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No plan to share data
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing In home nutrition counseling and standard nutrition education curriculum in people with Obesity and Heart Diseases, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 4 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in Body Mass Index (BMI) (time frame: 12 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 4 May 2021.