Hummus for Health: Dietary Quality and Health Outcomes in Toddlers

Not Applicable

Terminated

• Conditions: Obesity
• Interventions: Other: Lesson about vegetables; Other: Vegetables; Other: Hummus

• Registration Number: NCT02696278
• Lead Sponsor: Baylor College of Medicine

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-12-31
• Study First Submitted QC: 2016-02-26
• Study Start: 2016-03
• Study First Posted: 2016-03-02
• Primary Completion: 2016-12
• Study Completion: 2017-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-13
• Last Update Posted: 2017-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 139

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hummus and vegetables	Vegetables	Children will receive a lesson about vegetables and hummus and vegetables as part of their daily snack.
Vegetables only	Vegetables	Children will receive a lesson about vegetables and vegetables as part of their daily snack.
Hummus and vegetables	Hummus	Children will receive a lesson about vegetables and hummus and vegetables as part of their daily snack.
Hummus and vegetables	Lesson about vegetables	Children will receive a lesson about vegetables and hummus and vegetables as part of their daily snack.
Vegetables only	Lesson about vegetables	Children will receive a lesson about vegetables and vegetables as part of their daily snack.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States