Obesity, ChildhoodNCT03330743
Parent Mentor Interventions for Early Childhood Obesity
A study testing Parent Mentor with Standard Education and Parent Mentor with Positive Deviance in people with Obesity, Childhood, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this clinical trial is to identify the most effective strategy for intervention to change behaviors and affect weight status in obese children 2-5 years of age within the context of early childhood education centers. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Parent Mentor with Standard Education and Parent Mentor with Positive Deviance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 1 Sep 2020
- 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
- 2-5 years of age child, Hispanic ethnicity, attends the Head Start facility
Who cannot join
- any major medical disorder impairing growth or development
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this clinical trial is to identify the most effective strategy for intervention to change behaviors and affect weight status in obese children 2-5 years of age within the context of early childhood education centers.
Read the detailed description
The primary aim is to test an intervention to disseminate and promote the adoption of positive deviance behaviors among parents of obese Hispanic children using peer mentors. This trial will evaluate the efficacy and feasibility of this approach in reducing adiposity among a high-risk population of children.
Our central hypothesis is that children randomized to the intervention with a parent mentor using positive deviance methods with have a greater reduction in adiposity as measured by body mass index (BMI) compared with a parent mentor using traditional education or a control receiving usual education.
- Conditions
- Obesity, Childhood
- Being tested
- Parent Mentor with Standard Education, Parent Mentor with Positive Deviance
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Mentor with Standard EducationBehavioural
Parent mentors will provide coaching based on the current guidelines around diet and physical activity
Parent Mentor with Positive DevianceBehavioural
Parent mentors will provide coaching based on findings from the positive deviance study
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Not described |
| Parent Mentor | Placebo comparator | Not described Receives: Behavioral: Parent Mentor with Standard Education |
| Parent Mentor with Positive Deviance | Active comparator | Not described Receives: Behavioral: Parent Mentor with Positive Deviance |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMIz
standardized BMI for age and sex
Measured: 6 months post-enrollment
Secondary outcomes (1)
Self-efficacy
Parenting self-efficacy around specific topics
Measured: 6 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Jan 2018
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byron A Foster, Oregon Health and Science University
- Investigators
- Byron Foster, MD, MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330743
- Sponsor's protocol ID
- STUDY00017356
- Status last verified
- Apr 2022
- First submitted
- 31 Oct 2017
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Foster BA, Alvarez HO, Padilla T, Meyer JS. Longitudinal Examination of Hair Cortisol Concentrations and Weight Changes in Preschool-Aged Children of Latino Farmworkers. Child Obes. 2023 Sep;19(6):399-407. doi: 10.1089/chi.2022.0103. Epub 2022 Aug 24.
PubMed 36036733Foster BA, Weinstein K, Padilla T, Martinez C, Angeles-Ramos D. Growing Healthy Together: A Randomized Clinical Trial Using Parent Mentors for Early Childhood Obesity in Low-Income, Latino Families. Child Obes. 2022 Apr;18(3):168-177. doi: 10.1089/chi.2021.0165. Epub 2021 Oct 5.
PubMed 34613828Foster BA, Weinstein K, Shannon J. Growing Healthy Together: protocol for a randomized clinical trial using parent mentors for early childhood obesity intervention in a Latino community. Trials. 2019 Apr 25;20(1):235. doi: 10.1186/s13063-019-3342-3.
PubMed 31023345
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Mentor Interventions for Early Childhood Obesity
- ClinicalTrials.gov ID
- NCT03330743
- Acronym / sponsor ID
- STUDY00017356
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 6 Nov 2017 (actual)
- 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 purpose of this clinical trial is to identify the most effective strategy for intervention to change behaviors and affect weight status in obese children 2-5 years of age within the context of early childhood education centers.
Detailed description
The primary aim is to test an intervention to disseminate and promote the adoption of positive deviance behaviors among parents of obese Hispanic children using peer mentors. This trial will evaluate the efficacy and feasibility of this approach in reducing adiposity among a high-risk population of children.
Our central hypothesis is that children randomized to the intervention with a parent mentor using positive deviance methods with have a greater reduction in adiposity as measured by body mass index (BMI) compared with a parent mentor using traditional education or a control receiving usual education.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | – |
| Parent Mentor | Placebo comparator | Behavioral: Parent Mentor with Standard Education |
| Parent Mentor with Positive Deviance | Active comparator | Behavioral: Parent Mentor with Positive Deviance |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 2-5 years of age child, Hispanic ethnicity, attends the Head Start facility
Key exclusion criteria (1 listed)
- any major medical disorder impairing growth or development
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 |
|---|---|---|
| Parent Mentor with Standard EducationParent mentors will provide coaching based on the current guidelines around diet and physical activity | Behavioural | Parent Mentor |
| Parent Mentor with Positive DevianceParent mentors will provide coaching based on findings from the positive deviance study | Behavioural | Parent Mentor with Positive Deviance |
Primary outcome
BMIz
Time frame: 6 months post-enrollment
standardized BMI for age and sex
1 secondary outcome
Self-efficacy
Time frame: 6 months post-enrollment
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 29 Apr 2022.
- Derived from this study: PubMed 36036733Foster BA, Alvarez HO, Padilla T, Meyer JS. Longitudinal Examination of Hair Cortisol Concentrations and Weight Changes in Preschool-Aged Children of Latino Farmworkers. Child Obes. 2023 Sep;19(6):399-407. doi: 10.1089/chi.2022.0103. Epub 2022 Aug 24.
- Derived from this study: PubMed 34613828Foster BA, Weinstein K, Padilla T, Martinez C, Angeles-Ramos D. Growing Healthy Together: A Randomized Clinical Trial Using Parent Mentors for Early Childhood Obesity in Low-Income, Latino Families. Child Obes. 2022 Apr;18(3):168-177. doi: 10.1089/chi.2021.0165. Epub 2021 Oct 5.
- Derived from this study: PubMed 31023345Foster BA, Weinstein K, Shannon J. Growing Healthy Together: protocol for a randomized clinical trial using parent mentors for early childhood obesity intervention in a Latino community. Trials. 2019 Apr 25;20(1):235. doi: 10.1186/s13063-019-3342-3.
- Individual participant dataSharing planned: Undecided
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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.
Byron Foster, MD, MPH principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Mentor with Standard Education and Parent Mentor with Positive Deviance in people with Obesity, Childhood, run by Oregon Health and Science University 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 29 Apr 2022. 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. Some participants in this study may receive a placebo. 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?
BMIz (time frame: 6 months post-enrollment). 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 NCT03330743, which also lists 3 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 29 Apr 2022.