ObesityCOACHNCT04971044
Competency Based Approaches for Community Health 2
A study testing COACH and School Readiness Intervention in people with Obesity, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
One-size-fits-all approaches have failed to demonstrate sustained effects on childhood obesity, especially among low-income minority families, who experience constantly changing barriers to engaging in health behavior. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- COACH and School Readiness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2021to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- child with an age ≥4 years and <7 years;
- index parent/legal guardian with an age ≥18 years;
- English- or Spanish-speaking;
- self-identify as Hispanic/Latino;
- live in a home where Spanish is spoken;
- include an index parent/legal guardian with a body mass index of ≥25kg/m2 and <55 kg/m2;
Show all 30Show fewer
- include a child with a body mass index ≥5th percentile percentile for age and gender on standardized CDC growth curves;
- for participants intending to attend intervention sessions in person: reside within or frequent (i.e. work in or regularly visit) one of the following zip codes: South Nashville/Regions 1 and 2 (37013, 37204, 37210, 37211, 37217, 37220, 37076, 37086, 37167): surrounding the Coleman Recreation Center and Southeast Recreation Center; and Northeast Nashville/Madison/Region 3 (37115, 37138, 37072, 37207, 37216); for participants intending to attend intervention sessions via videoconference: participants may reside in any zip code;
- have parental commitment to participate in a two-year research study;
- have consistent mobile phone access;
- are without medical conditions necessitating limited physical activity as evaluated by a pre-screen;
- complete baseline data collection, including parent and child height and weight and at least 90% of baseline survey items;
- are considered underserved, measured by parent-self reporting that they or someone in their household are eligible for or participate in one of these programs or services: TennCare, CoverKids, WIC, Food Stamps (SNAP), Free and Reduced Price School Lunch and Breakfast, and/or Families First (TANF)
- Child exclusion criteria:
- Children outside the specified age range
- Children who are <5th percentile on standardized CDC growth curves
- Children who do not speak English or Spanish
- Children who are diagnosed with medical illnesses where regular exercise might be contraindicated
- Children who display dissenting behaviors during baseline assent or anthropometric data collection
- Children who do not otherwise meet the eligibility criteria listed in section above as determined by pre-screen
- Children who are diagnosed with autism
- Caregiver exclusion criteria include:
- Parents/legal guardians who are <18 years old;
- Parents/legal guardians with serious mental or neurologic illness that impairs ability to consent/participate;
- Parents/legal guardians with poor visual acuity (corrected vision worse than 20/50 with Rosenbaum Screener).
- Parents/legal guardians with BMI <25kg/m2 or BMI ≥55kg/m2
- Parents/legal guardians who are diagnosed with medical illnesses where regular exercise might be contraindicated
- Lack of parental commitment to participate consistently for a two-year period
- Lack of telephone contact
- Parents/legal guardians who do not otherwise meet the eligibility criteria listed in section above as determined by pre-screen
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: COACH: Competency Based Approaches for Community Health 2
One-size-fits-all approaches have failed to demonstrate sustained effects on childhood obesity, especially among low-income minority families, who experience constantly changing barriers to engaging in health behavior. Addressing obesity in these populations requires intervening in early childhood and situating interventions in the context of families and communities. Developing personalized childhood obesity prevention interventions with sustained effectiveness that support families in health behaviors despite dynamic barriers could address chronic disease risk and health disparities in low-income and minority communities.
Read the detailed description
Despite the recognition of health disparities in obesity, behavioral interventions among low-income and minority populations have consistently met with limited success. This is partially explained by social determinants of health. Constantly changing barriers at the household and community levels impede consistent engagement in healthy behaviors. The current proposal tests a novel, culturally-tailored and multi-level intervention designed to teach families to overcome dynamic barriers as the logical next step to address obesity among low-income Latino families. It is based on the premise that by implementing a personalized multi-level intervention that simultaneously addresses healthy weight for parents and children, we will improve body mass index (BMI) among Latino parent-child pairs.
COACH (COmpetency-Based Approaches to Community Health) implements a personally tailored approach, equipping families to engage in health behaviors despite dynamic barriers. COACH is a multi-level intervention targeting 1) the individual child through developmentally appropriate health behavior curriculum, 2) the family by addressing parent weight loss directly and engaging parents as agents of change for their children, and 3) the community by building capacity of Parks and Rec centers to offer parent-child programming. Using novel multi-component assessments throughout the study, the intervention identifies individual, family, and community barriers to healthy behaviors and delivers structured yet personalized intervention content in 7 domains: fruits/vegetables, snacks, sugary drinks, physical activity, sleep, media use, and parenting.
Building on a successful pilot, this proposal will implement a randomized controlled trial to test the effectiveness of COACH compared to an attention-matched school-readiness control group. We will enroll 300 parent-child pairs from Latino communities in Nashville, TN.
The goals of COACH are to 1) implement a novel personalized behavioral intervention, 2) test a two-generation solution to obesity, 3) address health disparities by reducing obesity among Latino families, and 4) develop a scalable and widely accessible approach to behavioral obesity interventions by delivering them in Parks and Rec centers.
- Conditions
- Obesity
- Being tested
- COACH, School Readiness Intervention
- Keywords
- Childhood Obesity, Behavioral Intervention, Parent-Child Pairs, Low-Income, Minority Populations, Hispanic/Latino Populations
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COACHBehavioural
Multi-Level Behavioral Intervention
School Readiness InterventionBehavioural
Multi-Level Language and School Readiness Intervention (Control Group)
| Study group | Role | What they receive |
|---|---|---|
| COACH Intervention | Experimental | COACH is a multi-level intervention, consisting of 1) developmentally appropriate health curriculum for 4-6 year old children; 2) family-based content that both targets parent weight loss and leverages a shared parent-child experience to improve family health behaviors; 3) community-level intervention to improve access and quality of family-based programming at local Parks and Rec centers. Receives: Behavioral: COACH |
| Educational Control | Active comparator | The control arm will consist of a school readiness intervention developed by education and literacy experts on our team and implemented at local libraries. It will include 1) child lessons from Puente de Cuentos, a systematic, language-based curriculum focused on dual language storytelling (narrative language), and 2) parent sessions designed to improve parents' knowledge and skills related to improving children's language production and storytelling skills, to ultimately support school readiness. Receives: Behavioral: School Readiness Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Body Mass Index
Measured prospectively and calculated from child weight/height measures
Measured: 24-month follow-up
Secondary outcomes (5)
Parent Body Mass Index
Measured prospectively and calculated from parent weight/height measures
Measured: 24-month follow-up
Child Obesity
Percent of children with BMI ≥95th percentile on standardized CDC growth curves
Measured: 24-month follow-up
Child Overweight
Percent of children with BMI percentile ≥85th but less than <95th percentile on standardized CDC growth curves
Measured: 24-month follow-up
Child Body Mass Index Percentage of the 95th Percentile
Child BMI percentage of the 95th percentile on standardized CDC growth curves
Measured: 24-month follow-up
Child Body Mass Index z-Scores
Child BMI z-scores on standardized CDC growth reference charts
Measured: 24-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start18 Nov 2021
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of North Carolina, Chapel Hill, Vanderbilt University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Bill Heerman, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971044
- Sponsor's protocol ID
- 1R01HD100458
- Other IDs
- 3R01HD100458-03S1
- Acronym
- COACH
- Status last verified
- Nov 2025
- First submitted
- 26 Oct 2020
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will plan to upload a de-identified dataset to the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) database (this upload also includes study protocols).
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COACH: Competency Based Approaches for Community Health 2
- ClinicalTrials.gov ID
- NCT04971044
- Acronym / sponsor ID
- COACH / 1R01HD100458
- Conditions
- Obesity
- Keywords
- Childhood Obesity, Behavioral Intervention, Parent-Child Pairs, Low-Income, Minority Populations, Hispanic/Latino Populations
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of North Carolina, Chapel Hill, Vanderbilt University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 21 Jul 2021 (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.
One-size-fits-all approaches have failed to demonstrate sustained effects on childhood obesity, especially among low-income minority families, who experience constantly changing barriers to engaging in health behavior. Addressing obesity in these populations requires intervening in early childhood and situating interventions in the context of families and communities. Developing personalized childhood obesity prevention interventions with sustained effectiveness that support families in health behaviors despite dynamic barriers could address chronic disease risk and health disparities in low-income and minority communities.
Detailed description
Despite the recognition of health disparities in obesity, behavioral interventions among low-income and minority populations have consistently met with limited success. This is partially explained by social determinants of health. Constantly changing barriers at the household and community levels impede consistent engagement in healthy behaviors. The current proposal tests a novel, culturally-tailored and multi-level intervention designed to teach families to overcome dynamic barriers as the logical next step to address obesity among low-income Latino families. It is based on the premise that by implementing a personalized multi-level intervention that simultaneously addresses healthy weight for parents and children, we will improve body mass index (BMI) among Latino parent-child pairs.
COACH (COmpetency-Based Approaches to Community Health) implements a personally tailored approach, equipping families to engage in health behaviors despite dynamic barriers. COACH is a multi-level intervention targeting 1) the individual child through developmentally appropriate health behavior curriculum, 2) the family by addressing parent weight loss directly and engaging parents as agents of change for their children, and 3) the community by building capacity of Parks and Rec centers to offer parent-child programming. Using novel multi-component assessments throughout the study, the intervention identifies individual, family, and community barriers to healthy behaviors and delivers structured yet personalized intervention content in 7 domains: fruits/vegetables, snacks, sugary drinks, physical activity, sleep, media use, and parenting.
Building on a successful pilot, this proposal will implement a randomized controlled trial to test the effectiveness of COACH compared to an attention-matched school-readiness control group. We will enroll 300 parent-child pairs from Latino communities in Nashville, TN.
The goals of COACH are to 1) implement a novel personalized behavioral intervention, 2) test a two-generation solution to obesity, 3) address health disparities by reducing obesity among Latino families, and 4) develop a scalable and widely accessible approach to behavioral obesity interventions by delivering them in Parks and Rec centers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COACH Intervention | Experimental | Behavioral: COACHCOACH is a multi-level intervention, consisting of 1) developmentally appropriate health curriculum for 4-6 year old children; 2) family-based content that both targets parent weight loss and leverages a shared parent-child experience to improve family health behaviors; 3) community-level intervention to improve access and quality of family-based programming at local Parks and Rec centers. |
| Educational Control | Active comparator | Behavioral: School Readiness InterventionThe control arm will consist of a school readiness intervention developed by education and literacy experts on our team and implemented at local libraries. It will include 1) child lessons from Puente de Cuentos, a systematic, language-based curriculum focused on dual language storytelling (narrative language), and 2) parent sessions designed to improve parents' knowledge and skills related to improving children's language production and storytelling skills, to ultimately support school readiness. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (30 listed)
- child with an age ≥4 years and <7 years;
- index parent/legal guardian with an age ≥18 years;
- English- or Spanish-speaking;
- self-identify as Hispanic/Latino;
- live in a home where Spanish is spoken;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| COACHMulti-Level Behavioral Intervention | Behavioural | COACH Intervention |
| School Readiness InterventionMulti-Level Language and School Readiness Intervention (Control Group) | Behavioural | Educational Control |
Primary outcome
Child Body Mass Index
Time frame: 24-month follow-up
Measured prospectively and calculated from child weight/height measures
5 secondary outcomes
Parent Body Mass Index
Time frame: 24-month follow-up
Child Obesity
Time frame: 24-month follow-up
Child Overweight
Time frame: 24-month follow-up
Child Body Mass Index Percentage of the 95th Percentile
Time frame: 24-month follow-up
Child Body Mass Index z-Scores
Time frame: 24-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Yes. We will plan to upload a de-identified dataset to the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) database (this upload also includes study protocols).
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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 COACH and School Readiness Intervention in people with Obesity, run by Vanderbilt University Medical Center 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 30 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Child Body Mass Index (time frame: 24-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2025.