Effects of Avocado Intake on the Nutritional Status of Families

NCT02903433 | Completed

• 1 other identifier: 160584
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Avocados are an excellent source of fiber, potassium, magnesium, and poly- and mono-unsaturated fats. They can be a nutrient dense component of healthful dietary patterns and have the potential to improve the cardiovascular disease (CVD) risk profiles of families in the United States (US). The proposed research plan will focus on the contribution of avocado intake to the reduction in CVD risk of US families, by examining the effects of avocado intake on the overall nutritional status of families. Of particular interest is establishing these effects in ethnic populations such as Hispanics/Latinos. On average, Hispanic/Latinos are at increased risk for metabolic diseases that predispose to CVD. This 6-month cluster randomized trial in Hispanic/Latino Americans aims to accurately determine the impact of avocados on the overall dietary pattern of their families. Future research will extend the results of the current trial to a larger sample of ethnically diverse families in order to evaluate whether sustained changes occur in nutritional, cardiovascular and metabolic health status.

Conditions

Cardiovascular Disease

Keywords

Avocado; Cardiovascular disease

Outcome Measures

Primary Outcomes (2)

• Change in family energy consumption at 3 and 6 months

  3 months and 6 months

• Change in distribution of macro and micronutrient intake at 6 months

  3 months and 6 months

Secondary Outcomes (7)

• Change in cardio-metabolic risk factors by serum lipids at 6 months

  3 months and 6 months

• Change in cardio-metabolic risk factors by insulin at 6 months

  3 months and 6 months

• Change in cardio-metabolic risk factors by glucose at 6 months

  3 months and 6 months

• Change in cardio-metabolic risk factors by computation of homeostasis model assessment at 6 months

  3 months and 6 months

• Change in nutritional status by red blood cell fatty acid composition at 6 months

  3 months and 6 months

Study Arms (2)

High Intake Group

EXPERIMENTAL

Throughout the entire study, this group will be provided with 14 avocados per week and will receive 12 bi-weekly home visits over a 6-month period during which they will receive specific brochures offering "diet tips". This group will be given specific advice on avocado consumption. Each month throughout the study, we will provide opportunities for families to visit the study kitchen at the SYHC to observe the staff preparing recipes with avocado, participate in preparing recipes, and taste recipes.

Other: High-intake avocados; Behavioral: Diet tips; Behavioral: Avocado consumption advice

Low Intake Group

ACTIVE COMPARATOR

This group will receive 3 avocados per week, as well as 12 bi-weekly home visits over a 6-month period during which they will be provided with the same educational materials (i.e., "Diet Tips") as those assigned to the "High intake" group. Participants in this group will be encouraged to improve the quality of their diets, but will not be given specific advice on avocado consumption. However, each month throughout the study, we will provide opportunities for families to visit the study kitchen at the SYHC to observe the staff preparing recipes with avocado, participate in preparing recipes, and taste recipes.

Other: Low-intake avocados; Behavioral: Diet tips; Behavioral: Avocado consumption advice

Interventions

High-intake avocados OTHER

Families will receive 14 avocados on a weekly basis.

High Intake Group

Low-intake avocados OTHER

Families will receive 3 avocados on a weekly basis.

Low Intake Group

Diet tips BEHAVIORAL

Diet tips will come from educational materials including culturally appropriate dietary and nutritional education materials, and personalized recommendations taken from http://www.choosemyplate.gov.

High Intake Group; Low Intake Group

Avocado consumption advice BEHAVIORAL

Recipe book with healthy recipe suggestions that include avocado.

High Intake Group; Low Intake Group

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Be part of a family that consists of at least 3 individuals, but no more than 8, who reside in the same home
• Self-identify as Latino or Hispanic
• Be older than 5 years of age

You may not qualify if:

• Families with members who have clinically severe chronic diseases requiring specific diets (e.g. stage IV congestive heart failure, chronic kidney disease requiring dialysis)
• Those allergic to avocados
• Those with LATEX allergy
• Families who are already high consumers of avocados (i.e. more than 1 avocado per adult and more than ½ avocado per child per day);
• Those who are unwilling to eat avocados.
• Family members with nursing or pregnant females or females planning to become pregnant
• Family members under the age of 5 years will not be counted toward the number of family members who will be expected to participate in the intervention (i.e., adhere to healthy diet tips or consume avocados)
• Families intending to move, or which include family members intending to move, within the next 6 months

Sponsors & Collaborators

• University of California, San Diego: lead
• San Diego State University: collaborator
• San Ysidro Health Center: collaborator

Study Sites (1)

South Bay Latino Research Center

Chula Vista, California, 91910, United States

Location

Related Publications (2)

• Allen TS, Doede AL, King CMB, Pacheco LS, Talavera GA, Denenberg JO, Eastman AS, Criqui MH, Allison MA. Nutritional Avocado Intervention Improves Physical Activity Measures in Hispanic/Latino Families: A Cluster RCT. AJPM Focus. 2023 Sep 20;2(4):100145. doi: 10.1016/j.focus.2023.100145. eCollection 2023 Dec.

  PMID: 37941823 DERIVED

• VanEvery H, Pacheco LS, Sun E, Allison MA, Gao X. The impact of avocado intake on anthropometric measures among Hispanic/Latino children and adolescents: A cluster randomized controlled trial. Clin Nutr ESPEN. 2023 Aug;56:94-103. doi: 10.1016/j.clnesp.2023.04.020. Epub 2023 May 3.

  PMID: 37344091 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Matthew A Allison, MD, MPH

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 16, 2016
• Study Start: April 20, 2017
• Primary Completion: January 8, 2019
• Study Completion: January 8, 2019
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)