ObesityNCT02373670
Parent Mentors Using Positive Deviance in Childhood Obesity
A study testing Promotion of positive deviance behaviors and Promotion of healthy behaviors in people with Obesity, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
A feasibility study randomizing participants (parents of children age 2-5 years old) to receive either education or a parent mentor with the aim of improving health behaviors and improving their body mass index z-score. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Promotion of positive deviance behaviors and Promotion of healthy behaviors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jan 2016
- 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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- BMI z-score >2
Who cannot join
- Medical conditions or receiving medications affecting weight
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
A feasibility study randomizing participants (parents of children age 2-5 years old) to receive either education or a parent mentor with the aim of improving health behaviors and improving their body mass index z-score.
- Conditions
- Obesity
- Being tested
- Promotion of positive deviance behaviors, Promotion of healthy behaviors
- Keywords
- Positive deviance, Peer mentors
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promotion of positive deviance behaviorsBehavioural
Using locally derived positive deviance findings to inform a behavioral intervention
Promotion of healthy behaviorsBehavioural
Using standardized healthy behavior education (EatPlayGrow curriculum from NHLBI)
| Study group | Role | What they receive |
|---|---|---|
| Parent Mentor | Experimental | Parent mentors using positive deviance findings to promote healthy behaviors Receives: Behavioral: Promotion of positive deviance behaviors |
| Education | Active comparator | Community health workers providing health education to promote healthy behaviors Receives: Behavioral: Promotion of healthy behaviors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index z-score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373670
- Sponsor's protocol ID
- 14-470H
- Status last verified
- Mar 2016
- First submitted
- 20 Feb 2015
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hollister EB, Foster BA, Dahdouli M, Ramirez J, Lai Z. Characterization of the Stool Microbiome in Hispanic Preschool Children by Weight Status and Time. Child Obes. 2018 Feb/Mar;14(2):122-130. doi: 10.1089/chi.2017.0122. Epub 2017 Oct 13.
PubMed 29028448Foster BA, Aquino CA, Gil M, Gelfond JA, Hale DE. A Pilot Study of Parent Mentors for Early Childhood Obesity. J Obes. 2016;2016:2609504. doi: 10.1155/2016/2609504. Epub 2016 Jun 9.
PubMed 27379182
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Mentors Using Positive Deviance in Childhood Obesity
- ClinicalTrials.gov ID
- NCT02373670
- Acronym / sponsor ID
- 14-470H
- Conditions
- Obesity
- Keywords
- Positive deviance, Peer mentors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 27 Feb 2015 (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.
A feasibility study randomizing participants (parents of children age 2-5 years old) to receive either education or a parent mentor with the aim of improving health behaviors and improving their body mass index z-score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent Mentor | Experimental | Behavioral: Promotion of positive deviance behaviorsParent mentors using positive deviance findings to promote healthy behaviors |
| Education | Active comparator | Behavioral: Promotion of healthy behaviorsCommunity health workers providing health education to promote healthy behaviors |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- BMI z-score >2
Key exclusion criteria (1 listed)
- Medical conditions or receiving medications affecting weight
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 |
|---|---|---|
| Promotion of positive deviance behaviorsUsing locally derived positive deviance findings to inform a behavioral intervention | Behavioural | Parent Mentor |
| Promotion of healthy behaviorsUsing standardized healthy behavior education (EatPlayGrow curriculum from NHLBI) | Behavioural | Education |
Primary outcome
Body mass index z-score
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
- Derived from this study: PubMed 29028448Hollister EB, Foster BA, Dahdouli M, Ramirez J, Lai Z. Characterization of the Stool Microbiome in Hispanic Preschool Children by Weight Status and Time. Child Obes. 2018 Feb/Mar;14(2):122-130. doi: 10.1089/chi.2017.0122. Epub 2017 Oct 13.
- Derived from this study: PubMed 27379182Foster BA, Aquino CA, Gil M, Gelfond JA, Hale DE. A Pilot Study of Parent Mentors for Early Childhood Obesity. J Obes. 2016;2016:2609504. doi: 10.1155/2016/2609504. Epub 2016 Jun 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promotion of positive deviance behaviors and Promotion of healthy behaviors in people with Obesity, run by The University of Texas Health Science Center at San Antonio 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Mar 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body mass index z-score (time frame: 6 months). 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 NCT02373670, which also lists 2 linked publications.
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 14 Mar 2016; AzTrials last refreshed its copy on 1 Nov 2026.