ObesityNCT02696278
Hummus for Health: Dietary Quality and Health Outcomes in Toddlers
A study testing Lesson about vegetables, Vegetables and Hummus in people with Obesity, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Lesson about vegetables, Vegetables and Hummus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Lesson about vegetables, Vegetables, Hummus
- Keywords
- gut microbiota, obesity, toddlers, fiber, unsaturated fats
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lesson about vegetablesOther
During the introductory period, children will receive a lesson about vegetables 3 days a week for 3 weeks.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Hummus and vegetables | Experimental | Children will receive a lesson about vegetables and hummus and vegetables as part of their daily snack. Receives: Other: Lesson about vegetables; Other: Vegetables; Other: Hummus |
| Vegetables only | Experimental | Children will receive a lesson about vegetables and vegetables as part of their daily snack. Receives: Other: Lesson about vegetables; Other: Vegetables |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Children's microbiome profile
For this measure stool samples from the children will be collected.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionJun 2017
Why it stopped: Study product voluntarily recalled by sponsor. Listeria identified at the manufacturing facility (not in tested finished product).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Sabra Dipping Company, LLC
- Responsible party
- Principal investigator, Sheryl Hughes, Baylor College of Medicine
- Investigators
- Sheryl O Hughes, PhD, Principal investigator, Baylor College of MedicineAlexis Frazier-Wood, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696278
- Sponsor's protocol ID
- 47364-I
- Other IDs
- H-38273
- Status last verified
- Jul 2017
- First submitted
- 31 Dec 2015
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 30169719
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hummus for Health: Dietary Quality and Health Outcomes in Toddlers
- ClinicalTrials.gov ID
- NCT02696278
- Acronym / sponsor ID
- 47364-I
- Conditions
- Obesity
- Keywords
- gut microbiota, obesity, toddlers, fiber, unsaturated fats
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study product voluntarily recalled by sponsor. Listeria identified at the manufacturing facility (not in tested finished product).
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Sabra Dipping Company, LLC
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hummus and vegetables | Experimental | Other: Lesson about vegetables, Other: Vegetables, Other: HummusChildren will receive a lesson about vegetables and hummus and vegetables as part of their daily snack. |
| Vegetables only | Experimental | Other: Lesson about vegetables, Other: VegetablesChildren will receive a lesson about vegetables and vegetables as part of their daily snack. |
Who may qualify
- Ages
- 12 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lesson about vegetablesDuring the introductory period, children will receive a lesson about vegetables 3 days a week for 3 weeks. | Other | Hummus and vegetables, Vegetables only |
| VegetablesDuring 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 and vegetables, Vegetables only |
| HummusDuring 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. | Other | Hummus and vegetables |
Primary outcome
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.
Children's microbiome profile
Time frame: 8 weeks
For this measure stool samples from the children will be collected.
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.
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.
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.
4 secondary outcomes
Parent's Healthy Eating Index total score
Time frame: 8 weeks
Parent's daily consumption of greens and beans
Time frame: 8 weeks
Parent's daily consumption of vegetables
Time frame: 8 weeks
Parent's daily consumption of unsaturated fats
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Study product voluntarily recalled by sponsor. Listeria identified at the manufacturing facility (not in tested finished product).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- Derived from this study: PubMed 30169719Arlinghaus 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheryl O Hughes, PhD principal investigator
Baylor College of Medicine
Alexis Frazier-Wood, PhD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lesson about vegetables, Vegetables and Hummus in people with Obesity, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study product voluntarily recalled by sponsor. Listeria identified at the manufacturing facility (not in tested finished product).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Healthy Eating Index total score (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02696278, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2017.