Hummus for Health: Dietary Quality and Health Outcomes in Toddlers

The goal of this study is to examine the effect of increasing children's intake of fiber and unsaturated fat, through daily servings of hummus and vegetables, on their microbiome profile.

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Other: Lesson about vegetables; Other: Vegetables; Other: Hummus

Detailed Description

Population: The investigators will recruit 104 children ages 12-24 months from daycare centers in the Houston and surrounding areas.

Study design: The study will be conducted at daycare centers and will consist of three phases - a 'lead in period' (two weeks) where baseline measurements will be taken followed by an 'Introductory period' (three weeks) where the new food will be introduced on three days during snack time for three weeks. The introductory phase will be followed by the 'intervention period' (three weeks) where children will receive daily servings of hummus and vegetables.

Lead in period (two weeks): Two 24-hour dietary recalls will be conducted on each child (parent-report); one 24-hour dietary recall (over a weekend) will be conducted on each parent (self-report). Three dirty diapers will be collected within the time span of a week for microbiome analysis.

Introductory period (three weeks): Since children typically take several introductions of a new food to accept it, and the investigators wish to ensure a high acceptance of hummus, the investigators will spend three weeks introducing the food. The food will be provided on three days during snack time for three weeks. Prior to introducing the food, children will receive a 'lesson' involving information about vegetables using a combination of songs, rhymes and craft activities. Following the lesson, hummus and vegetables will be provided in the hummus group; vegetables only in the control group. Hummus will be provided in a pre-packaged 2 ounce serving cup; vegetables will conform to age-appropriate servings designated by the American Academy of Pediatrics (AAP) and will consist of soft vegetables (e.g., winter squash) and lightly steamed, but chilled, hard vegetables (e.g., carrots, broccoli).

Intervention period (three weeks): Similar to the introductory period, a serving of either hummus and vegetables or vegetables only will be provided to the children during snack time. The food will be provided daily for three weeks. In the final week of the intervention period, two 24-hour dietary recalls (one weekday and one weekend) will be conducted on the child (parent-report). In addition, one weekend 24-hour dietary recall will be conducted on the parent (self-report). Three dirty diapers will be collected on the child during the final week for microbiome analysis.

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children between the ages of 12 and 24 month old.
• Children attending daycare at least 3 days a week.
• Children with a parental-report of being hummus-naive.

Exclusion Criteria:

• Any child following a specific dietary regimen or that has religious restrictions or food allergies that may affect food consumption.
• Children with parent-reported antibiotic use in the previous 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hummus and vegetables; Children will receive a lesson about vegetables and hummus and vegetables as part of their daily snack.	Other: Lesson about vegetables; During the introductory period, children will receive a lesson about vegetables 3 days a week for 3 weeks.; Other: Vegetables; During the introductory period, children will be served vegetables 3 days a week for 3 weeks during snack time at their daycare center. During the intervention period, children will receive vegetables everyday for 3 weeks during snack time at their daycare center.; Other: Hummus; During the introductory period, children will be served hummus, depending on their group assignment, 3 days a week for 3 weeks during snack time at their daycare center. During the intervention period, children will receive hummus, depending on their group assignment, everyday for 3 weeks during snack time at their daycare center.
Experimental: Vegetables only; Children will receive a lesson about vegetables and vegetables as part of their daily snack.	Other: Lesson about vegetables; During the introductory period, children will receive a lesson about vegetables 3 days a week for 3 weeks.; Other: Vegetables; During the introductory period, children will be served vegetables 3 days a week for 3 weeks during snack time at their daycare center. During the intervention period, children will receive vegetables everyday for 3 weeks during snack time at their daycare center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's Healthy Eating Index total score	Parent-report of 24-hour dietary recalls of the child's consumption will be used for this measure.	8 weeks
Children's microbiome profile	For this measure stool samples from the children will be collected.	8 weeks
Children's daily consumption of greens and beans	Parent-report of 24-hour dietary recalls of the child's consumption will be used for this measure.	8 weeks
Children's daily consumption of vegetables	Parent-report of 24-hour dietary recalls of the child's consumption will be used for this measure.	8 weeks
Children's daily consumption of unsaturated fats	Parent-report of 24-hour dietary recalls of the child's consumption will be used for this measure.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent's Healthy Eating Index total score	Self-report of 24-hour dietary recalls of the parent's consumption will be used for this measure.	8 weeks
Parent's daily consumption of greens and beans	Self-report of 24-hour dietary recalls of the parent's consumption will be used for this measure.	8 weeks
Parent's daily consumption of vegetables	Self-report of 24-hour dietary recalls of the parent's consumption will be used for this measure.	8 weeks
Parent's daily consumption of unsaturated fats	Self-report of 24-hour dietary recalls of the parent's consumption will be used for this measure.	8 weeks

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: Sabra Dipping Company, LLC
• Investigators: Principal Investigator: Sheryl O Hughes, PhD, Baylor College of Medicine; Principal Investigator: Alexis Frazier-Wood, PhD, Baylor College of Medicine

Publications and helpful links

General Publications

• Arlinghaus KR, Vollrath K, Hernandez DC, Momin SR, O'Connor TM, Power TG, Hughes SO. Authoritative parent feeding style is associated with better child dietary quality at dinner among low-income minority families. Am J Clin Nutr. 2018 Oct 1;108(4):730-736. doi: 10.1093/ajcn/nqy142.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: December 31, 2015
• First Submitted That Met QC Criteria: February 26, 2016
• First Posted (Estimate): March 2, 2016

Study Record Updates

• Last Update Posted (Actual): July 17, 2017
• Last Update Submitted That Met QC Criteria: July 13, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: obesity; gut microbiota; toddlers; fiber; unsaturated fats
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 47364-I; H-38273 (Other Identifier: Baylor College of Medicine)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO