Clinical trial NCT02696278: Hummus for Health: Dietary Quality and Health Outcomes in Toddlers
Official title: Hummus for Health: Dietary Quality and Health Outcomes in Toddlers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Keywords: gut microbiota
obesity
toddlers
fiber
unsaturated fats
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Sabra Dipping Company, LLC
First posted: 2016-03-02
Enrollment: 139
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Children's Healthy Eating Index total score
timeFrame: 8 weeks
measure: Children's microbiome profile
timeFrame: 8 weeks
measure: Children's daily consumption of greens and beans
timeFrame: 8 weeks
measure: Children's daily consumption of vegetables
timeFrame: 8 weeks
measure: Children's daily consumption of unsaturated fats
timeFrame: 8 weeks
Secondary outcomes:
measure: Parent's Healthy Eating Index total score
timeFrame: 8 weeks
measure: Parent's daily consumption of greens and beans
timeFrame: 8 weeks
measure: Parent's daily consumption of vegetables
timeFrame: 8 weeks
measure: Parent's daily consumption of unsaturated fats
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Sheryl O Hughes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor College of Medicine
name: Alexis Frazier-Wood, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.