NCT02696278

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 17, 2017

Status Verified

July 1, 2017

Enrollment Period

9 months

First QC Date

December 31, 2015

Last Update Submit

July 13, 2017

Conditions

Obesity

Keywords

gut microbiotaobesitytoddlersfiberunsaturated fats

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (4)

  • Parent's Healthy Eating Index total score

    8 weeks

  • Parent's daily consumption of greens and beans

    8 weeks

  • Parent's daily consumption of vegetables

    8 weeks

  • Parent's daily consumption of unsaturated fats

    8 weeks

Study Arms (2)

Hummus and vegetables

EXPERIMENTAL

Children will receive a lesson about vegetables and hummus and vegetables as part of their daily snack.

Other: Lesson about vegetablesOther: VegetablesOther: Hummus

Vegetables only

EXPERIMENTAL

Children will receive a lesson about vegetables and vegetables as part of their daily snack.

Other: Lesson about vegetablesOther: Vegetables

Interventions

Lesson about vegetablesOTHER

During the introductory period, children will receive a lesson about vegetables 3 days a week for 3 weeks.

Hummus and vegetablesVegetables only
VegetablesOTHER

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.

Hummus and vegetablesVegetables only
HummusOTHER

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.

Hummus and vegetables

Eligibility Criteria

Age12 Months - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 30169719DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Vegetables

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Sheryl O Hughes, PhD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

  • Alexis Frazier-Wood, PhD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 31, 2015

First Posted

March 2, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

July 17, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)