Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224887
Status:
COMPLETED
Last Update Posted:
2021-05-04
First Post:
2005-09-21
Brief Title:
Family-Based Nutrition Intervention for Latino Children
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Family-Based Nutrition Intervention for Latino Children
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 406 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 US population and are the fastest growing minority group in the USA Poor dietary practices especially food habits that are acquired as families acculturate to the American food supply are thought to be associated with childrens 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 childrens 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 Whats to Eat developed for this population and photographs of each familys 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 childrens BMI The secondary outcome is household food supplies We hypothesize that within a one year timeframe childrens whose mothers are exposed to the FBC will have lower BMIs 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 familys 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 Whats to Eat with the CHA and discuss food related parenting issues In the subsequent five sessions photographs of the familys 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 - Childrens 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 01 kg using digital scales with subjects wearing light indoor clothing without shoes If the two measures differ by more than 02 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 Childrens demographic variables will include gender age and grade level
Household Level of Food Security Food security is defined as peoples 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 USDA 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 ie childrens food intake is restricted
Cardiovascular disease accounted for 406 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 US population and are the fastest growing minority group in the USA Poor dietary practices especially food habits that are acquired as families acculturate to the American food supply are thought to be associated with childrens 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 childrens 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 Whats to Eat developed for this population and photographs of each familys 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 childrens BMI The secondary outcome is household food supplies We hypothesize that within a one year timeframe childrens whose mothers are exposed to the FBC will have lower BMIs 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 familys 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 Whats to Eat with the CHA and discuss food related parenting issues In the subsequent five sessions photographs of the familys 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 - Childrens 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 01 kg using digital scales with subjects wearing light indoor clothing without shoes If the two measures differ by more than 02 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 Childrens demographic variables will include gender age and grade level
Household Level of Food Security Food security is defined as peoples 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 USDA 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 ie childrens food intake is restricted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL070218 | NIH | None | httpsreporternihgovquickSearchR01HL070218 |