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Hummus for Health: Dietary Quality and Health Outcomes in Toddlers

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ClinicalTrials.gov Identifier: NCT02696278
Recruitment Status : Terminated (Study product voluntarily recalled by sponsor. Listeria identified at the manufacturing facility (not in tested finished product).)
First Posted : March 2, 2016
Last Update Posted : July 17, 2017
Sponsor:
Collaborator:
Sabra Dipping Company, LLC
Information provided by (Responsible Party):
Sheryl Hughes, 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.

Condition or disease Intervention/treatment Phase
Obesity Other: Lesson about vegetables Other: Vegetables Other: Hummus Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Hummus for Health: Dietary Quality and Health Outcomes in Toddlers
Study Start Date : March 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : June 2017

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.




Primary Outcome Measures :
  1. Children's Healthy Eating Index total score [ Time Frame: 8 weeks ]
    Parent-report of 24-hour dietary recalls of the child's consumption will be used for this measure.

  2. Children's microbiome profile [ Time Frame: 8 weeks ]
    For this measure stool samples from the children will be collected.

  3. Children's daily consumption of greens and beans [ Time Frame: 8 weeks ]
    Parent-report of 24-hour dietary recalls of the child's consumption will be used for this measure.

  4. Children's daily consumption of vegetables [ Time Frame: 8 weeks ]
    Parent-report of 24-hour dietary recalls of the child's consumption will be used for this measure.

  5. Children's daily consumption of unsaturated fats [ Time Frame: 8 weeks ]
    Parent-report of 24-hour dietary recalls of the child's consumption will be used for this measure.


Secondary Outcome Measures :
  1. Parent's Healthy Eating Index total score [ Time Frame: 8 weeks ]
    Self-report of 24-hour dietary recalls of the parent's consumption will be used for this measure.

  2. Parent's daily consumption of greens and beans [ Time Frame: 8 weeks ]
    Self-report of 24-hour dietary recalls of the parent's consumption will be used for this measure.

  3. Parent's daily consumption of vegetables [ Time Frame: 8 weeks ]
    Self-report of 24-hour dietary recalls of the parent's consumption will be used for this measure.

  4. Parent's daily consumption of unsaturated fats [ Time Frame: 8 weeks ]
    Self-report of 24-hour dietary recalls of the parent's consumption will be used for this measure.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696278


Locations
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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Sabra Dipping Company, LLC
Investigators
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Principal Investigator: Sheryl O Hughes, PhD Baylor College of Medicine
Principal Investigator: Alexis Frazier-Wood, PhD Baylor College of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sheryl Hughes, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02696278    
Other Study ID Numbers: 47364-I
H-38273 ( Other Identifier: Baylor College of Medicine )
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sheryl Hughes, Baylor College of Medicine:
gut microbiota
obesity
toddlers
fiber
unsaturated fats
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight