Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Family-Based Nutrition Intervention for Latino Children

8 avril 2021 mis à jour par: Stanford University

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.

Aperçu de l'étude

Description détaillée

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).

Type d'étude

Interventionnel

Inscription (Réel)

307

Phase

  • N'est pas applicable

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

6 ans à 9 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: in home nutrition counseling
In-home family-based behavioral counseling using in-person and video interventions delivered by community health advisors
In home family-based behavioral counseling
Comparateur actif: standard nutrition education curriculum
standard nutrition education curriculum consisting of video and lesson plans based on USDA Food Guide pyramid
video and lesson plans based on USDA Food Guide Pyramid

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Mean Change in Body Mass Index (BMI)
Délai: 12 months
child's Body Mass Index
12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2003

Achèvement primaire (Réel)

1 juillet 2008

Achèvement de l'étude (Réel)

1 juillet 2008

Dates d'inscription aux études

Première soumission

21 septembre 2005

Première soumission répondant aux critères de contrôle qualité

21 septembre 2005

Première publication (Estimation)

23 septembre 2005

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 mai 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 avril 2021

Dernière vérification

1 avril 2021

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 320
  • R01HL070218 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

No plan to share data

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Maladies cardiaques

Essais cliniques sur In home nutrition counseling

3
S'abonner