Family-Based Nutrition Intervention for Latino Children

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00224887
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 307
• Arms: 2
• Duration (Months): 58

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Heart Diseases	Behavioral: In home nutrition counseling; Other: standard nutrition education curriculum	N/A

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:
2. 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

• Study Type: Interventional
• Actual Enrollment: 307 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Family-Based Nutrition Intervention for Latino Children
• Study Start Date: Sep 1, 2003
• Actual Primary Completion Date: Jul 1, 2008
• Actual Study Completion Date: Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: in home nutrition counseling In-home family-based behavioral counseling using in-person and video interventions delivered by community health advisors	Behavioral: In home nutrition counseling; In home family-based behavioral counseling
Active Comparator: standard nutrition education curriculum standard nutrition education curriculum consisting of video and lesson plans based on USDA Food Guide pyramid	Other: standard nutrition education curriculum; video and lesson plans based on USDA Food Guide Pyramid

Outcome Measures

Primary Outcome Measures

1. Mean Change in Body Mass Index (BMI) [12 months]

   child's Body Mass Index

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 9 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

The inclusion criteria for the study are:

1. Ethnicity: Mother is of Mexican descent and identifies with the Mexican-American community.

2. Age: Child is between 6 and 9 years 11.9 months old.

3. Family lives in the San Jose area

4. Family does not plan to move out of the area within the next 12 months.

The exclusion criteria for the study are:

1. Metabolic disease/syndrome associated with obesity.

2. Diabetes

3. Chronic gastro-intestinal disease

4. Chronic renal disease

5. Heart disease

6. Eating disorders

7. Aids/HIV infection

8. Use of steroids

9. Use of insulin injections

10. Use of oral antidiabetic agents

11. Use of thyroid hormones

12. Use of growth hormones

13. Other diseases or use of other medications that may impact growth based on Dr. Mendoza's assessment.

14. Family shares food with 2 other families with children under the age of 12.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Stanford University
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT00224887
• Other Study ID Numbers: 320; R01HL070218
• First Posted: Sep 23, 2005
• Last Update Posted: May 4, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Heart Diseases

Study Results

Participant Flow

Arm/Group Title	in Home Nutrition Counseling	Standard Nutrition Education Curriculum
Arm/Group Description	In-home family-based behavioral counseling using in-person and video interventions delivered by community health advisors In home nutrition counseling: In home family-based behavioral counseling	standard nutrition education curriculum consisting of video and lesson plans based on USDA Food Guide pyramid standard nutrition education curriculum: video and lesson plans based on USDA Food Guide Pyramid
Period Title: Overall Study
STARTED	154	153
COMPLETED	148	147
NOT COMPLETED	6	6

Baseline Characteristics

Arm/Group Title	in Home Nutrition Counseling	Standard Nutrition Education Curriculum	Total
Arm/Group Description	In-home family-based behavioral counseling using in-person and video interventions delivered by community health advisors In home nutrition counseling: In home family-based behavioral counseling	standard nutrition education curriculum consisting of video and lesson plans based on USDA Food Guide pyramid standard nutrition education curriculum: video and lesson plans based on USDA Food Guide Pyramid	Total of all reporting groups
Overall Participants	154	153	307
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	7.7 (1.2)	7.8 (1.1)	7.7 (1.2)
Sex: Female, Male (Count of Participants)
Female	117 76%	104 68%	221 72%
Male	37 24%	49 32%	86 28%

Outcome Measures

1. Primary Outcome

Title	Mean Change in Body Mass Index (BMI)
Description	child's Body Mass Index
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	in Home Nutrition Counseling	Standard Nutrition Education Curriculum
Arm/Group Description	In-home family-based behavioral counseling using in-person and video interventions delivered by community health advisors In home nutrition counseling: In home family-based behavioral counseling	standard nutrition education curriculum consisting of video and lesson plans based on USDA Food Guide pyramid standard nutrition education curriculum: video and lesson plans based on USDA Food Guide Pyramid
Measure Participants	154	153
Mean (Standard Deviation) [kg/m^2]	0.52 (1.56)	0.66 (1.43)

Adverse Events

Time Frame	12 months
Adverse Event Reporting Description	The study was considered to be minimal risk. Interventions were informational/educational and did not include medications or invasive testing/procedures.
Arm/Group Title	in Home Nutrition Counseling		Standard Nutrition Education Curriculum
Arm/Group Description	In-home family-based behavioral counseling using in-person and video interventions delivered by community health advisors In home nutrition counseling: In home family-based behavioral counseling		standard nutrition education curriculum consisting of video and lesson plans based on USDA Food Guide pyramid standard nutrition education curriculum: video and lesson plans based on USDA Food Guide Pyramid
All Cause Mortality
	in Home Nutrition Counseling		Standard Nutrition Education Curriculum
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/154 (0%)		0/153 (0%)
Serious Adverse Events
	in Home Nutrition Counseling		Standard Nutrition Education Curriculum
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/154 (0%)		0/153 (0%)
Other (Not Including Serious) Adverse Events
	in Home Nutrition Counseling		Standard Nutrition Education Curriculum
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/154 (0%)		0/153 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.