Pediatric ObesityENCIRCLENCT04406441
Patient-Clinic-Community Integration to Prevent Obesity Among Rural Preschool Children
A study testing Patient Reported Outcome Well Child Visit and Patient Reported Outcome Well Child Visit + Food Care in people with Pediatric Obesity and Preventive Medicine, run by Geisinger Clinic at 1 site in United States.
Trial summary
The goal of this research study is to compare two enhancements to well-child visits at Geisinger designed to promote family-centered counseling for the prevention of obesity in a high-risk population of rural, lower income, preschool-aged children. Read more about this study
- Who is it for?
- Ages 20 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity, Preventive Medicine, Mentoring
- What is being tested?
- Patient Reported Outcome Well Child Visit and Patient Reported Outcome Well Child Visit + Food Care
- Type of treatment
- Vaccines, Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,040 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2020to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age (20-months to 59-months, 29-days old)
- BMI-for-age and -sex >50th percentile based on WHO growth standards
- Parent commitment to participate in 18-month study
- Plans to attend scheduled WCV and recommended follow-up WCV in 12 months
- No plans to move or change health systems in 2 years
- Parent age > 18 years
- Parent is English-speaking
- Household is considered lower-income (i.e., eligible for or receiving Special Supplemental Nutrition Program for Women, Infants and Children [WIC], Supplemental Nutrition Assistance Program [SNAP], Temporary Assistance for Needy Families [TANF], Medicaid, or Children's Health Insurance Program [CHIP]) or screens positive for food insecurity.
Who cannot join
- Another child in family is participating
- Pre-existing medical exclusions (cancer, type 1 diabetes, major developmental delays such as autism)
- Parents with self-reported major depression will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this research study is to compare two enhancements to well-child visits at Geisinger designed to promote family-centered counseling for the prevention of obesity in a high-risk population of rural, lower income, preschool-aged children. Compared to the standard well-child visit, enhancements will offer advantages to obesity prevention, parent involvement in counseling, lifestyle behaviors, and food resource management.
- Conditions
- Pediatric Obesity, Preventive Medicine, Mentoring, Food Supply
- Being tested
- Patient Reported Outcome Well Child Visit, Patient Reported Outcome Well Child Visit + Food Care
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Reported Outcome Well Child VisitBehavioural
Parents will complete the Family Nutrition and Physical Activity risk assessment (Patient Reported Outcome) prior to scheduled well child visit. Parent reported data is integrated into the child's electronic health record to inform the child's primary care provider and the provision of preventive counseling. The primary care provider documents preventive care provided.
Patient Reported Outcome Well Child Visit + Food CareBehavioural
Adapted Parent Training Program will be delivered via telehealth (video or telephone) to parents by trained Wellness Coaches as 6 individual sessions, distributed throughout a 26-week intervention period. Cooking Matters grocery store tours will be delivered (in-person or virtual) to parents by trained grocery store nutritionists during the 26-week intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Participants will attend regularly scheduled well child visits (WCV) that follow standard clinical guidelines. Well child visits will include review of history, age-appropriate measurements (height/length, weight, body mass index (BMI), blood pressure), sensory and developmental screenings, physical exam, immunizations, oral health review, and anticipatory guidance (preventive counseling). |
| Patient Reported Outcome | Active comparator | Arm 2 builds on the standard of care WCV by adding a patient reported outcome measure, the Family Nutrition and Physical Activity risk assessment, to inform family-centered preventative counseling during clinical care. Receives: Behavioral: Patient Reported Outcome Well Child Visit |
| Patient Reported Outcome + Food Care | Active comparator | Participants will receive all Arm 2 components, in addition to be referred to both the Geisinger Wellness Program for a Parent Training Program and a grocery store nutritionist for a tour aligned with the Cooking Matters program. Receives: Behavioral: Patient Reported Outcome Well Child Visit + Food Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in BMI Z-score, Based on WHO Growth Standards
BMI values will be obtained from Geisinger clinical care visits, documented in the EHR and standardized or parent-reported. Values obtained at well child visits during the study period, ideally 12 months, 1 day apart will be utilized but values within a 9- to 18-month span of baseline to 1-year follow up may be used (e.g., 3 months pre-baseline WCV to 15 months post-baseline, baseline WCV to 18-months post-baseline, etc.) to assess the primary outcome. A z-score of 0 represents the population mean. Higher z-scores represent worse outcomes. BMI z-score over >=1 indicates possible risk for overweight.
Measured: 1-year
Secondary outcomes (3)
United States Household Food Security Survey Module: Six-Item Short Form
This questionnaire uses 6 items to provide a scale of food security of high food security to very low food security. Scoring: Responses of "often" or "sometimes" on questions Q1 and Q2, and "yes" on Q3, Q5, and Q6 are coded as affirmative (yes). Responses of "almost every month" and "some months but not every month" on Q4 are coded as affirmative (yes). The sum of affirmative responses to the six questions in the module is the household's raw score on the scale. Food security status is assigned as follows: Raw score 0-1-High or marginal food security (raw score 1 may be considered marginal food security, but a large proportion of households that would be measured as having marginal food security using the household or adult scale will have raw score zero on the six-item scale); Raw score 2-4-Low food security. Raw score 5-6-Very low food security. Percentage of participants with low or very low food security scores were reported.
Measured: 1-year
Modified Version of Perceived Involvement in Care Scale
The Modified Perceived Involvement in Care Scale (M-PICS) measures patients' perceptions of doctor-patient communication during the medical encounter. PICs includes 4 domains including 1-Health care provider information 2- Patient information 3- Patient decision making 4- Health care provider facilitation. The total score combines these 4 domains with a range from 20 poor-100 high reported at 12-month follow-up.
Measured: 1-year
Food Resource Management
Nine items from the Cooking Matters Food Resource Management survey that assess 2 subscales (each scored on 1-5 item Likert scale)- Food Resource Management Practices (indicating the frequency with which respondents engaged in behaviors to maximize food resources) and Food Resource Management Confidence (extent to which participants showed self-confidence in shopping, preparing foods, and managing food resources on a budget). Higher scores indicate more frequent practices and greater confidence, respectively. There is not a summary score. The scoring for each subscale uses the average of items within that subscale.
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start17 Aug 2020
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pediatric 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,040 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University, Iowa State University, University of Nebraska, Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Lisa Bailey-Davis, DEd, RD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406441
- Sponsor's protocol ID
- 2020-0207
- Acronym
- ENCIRCLE
- Status last verified
- Feb 2025
- First submitted
- 21 May 2020
- Last updated
- 5 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Slusser W, Frankel F, Robison K, Fischer H, Cumberland WG, Neumann C. Pediatric overweight prevention through a parent training program for 2-4 year old Latino children. Child Obes. 2012 Feb;8(1):52-9. doi: 10.1089/chi.2011.0060.
PubMed 22799481Bailey-Davis L, Kling SMR, Wood GC, Cochran WJ, Mowery JW, Savage JS, Stametz RA, Welk GJ. Feasibility of enhancing well-child visits with family nutrition and physical activity risk assessment on body mass index. Obes Sci Pract. 2019 Apr 24;5(3):220-230. doi: 10.1002/osp4.339. eCollection 2019 Jun.
PubMed 31275595Bailey-Davis L, Moore AM, Poulsen MN, Dzewaltowski DA, Cummings S, DeCriscio LR, Hosterman JF, Huston D, Kirchner HL, Lutcher S, McCabe C, Welk GJ, Savage JS. Comparing enhancements to well-child visits in the prevention of obesity: ENCIRCLE cluster-randomized controlled trial. BMC Public Health. 2022 Dec 26;22(1):2429. doi: 10.1186/s12889-022-14827-w.
PubMed 36572870Potts BA, Wood GC, Bailey-Davis L. Agreement between parent-report and EMR height, weight, and BMI among rural children. Front Nutr. 2024 Mar 1;11:1279931. doi: 10.3389/fnut.2024.1279931. eCollection 2024.
PubMed 38496791
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Clinic-Community Integration to Prevent Obesity Among Rural Preschool Children
- ClinicalTrials.gov ID
- NCT04406441
- Acronym / sponsor ID
- ENCIRCLE / 2020-0207
- Conditions
- Pediatric Obesity, Preventive Medicine, Mentoring, Food Supply
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,040 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Collaborators
- Penn State University, Iowa State University, University of Nebraska, Patient-Centered Outcomes Research Institute
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Posted 5 Mar 2025
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 research study is to compare two enhancements to well-child visits at Geisinger designed to promote family-centered counseling for the prevention of obesity in a high-risk population of rural, lower income, preschool-aged children. Compared to the standard well-child visit, enhancements will offer advantages to obesity prevention, parent involvement in counseling, lifestyle behaviors, and food resource management.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Participants will attend regularly scheduled well child visits (WCV) that follow standard clinical guidelines. Well child visits will include review of history, age-appropriate measurements (height/length, weight, body mass index (BMI), blood pressure), sensory and developmental screenings, physical exam, immunizations, oral health review, and anticipatory guidance (preventive counseling). |
| Patient Reported Outcome | Active comparator | Behavioral: Patient Reported Outcome Well Child VisitArm 2 builds on the standard of care WCV by adding a patient reported outcome measure, the Family Nutrition and Physical Activity risk assessment, to inform family-centered preventative counseling during clinical care. |
| Patient Reported Outcome + Food Care | Active comparator | Behavioral: Patient Reported Outcome Well Child Visit + Food CareParticipants will receive all Arm 2 components, in addition to be referred to both the Geisinger Wellness Program for a Parent Training Program and a grocery store nutritionist for a tour aligned with the Cooking Matters program. |
Who may qualify
- Ages
- 20 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age (20-months to 59-months, 29-days old)
- BMI-for-age and -sex >50th percentile based on WHO growth standards
- Parent commitment to participate in 18-month study
- Plans to attend scheduled WCV and recommended follow-up WCV in 12 months
- No plans to move or change health systems in 2 years
Key exclusion criteria (3 listed)
- Another child in family is participating
- Pre-existing medical exclusions (cancer, type 1 diabetes, major developmental delays such as autism)
- Parents with self-reported major depression will be excluded.
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 |
|---|---|---|
| Patient Reported Outcome Well Child VisitParents will complete the Family Nutrition and Physical Activity risk assessment (Patient Reported Outcome) prior to scheduled well child visit. Parent reported data is integrated into the child's electronic health record to inform the child's primary care provider and the provision of preventive counseling. The primary care provider documents preventive care provided. | Behavioural | Patient Reported Outcome |
| Patient Reported Outcome Well Child Visit + Food CareAdapted Parent Training Program will be delivered via telehealth (video or telephone) to parents by trained Wellness Coaches as 6 individual sessions, distributed throughout a 26-week intervention period. Cooking Matters grocery store tours will be delivered (in-person or virtual) to parents by trained grocery store nutritionists during the 26-week intervention period. | Behavioural | Patient Reported Outcome + Food Care |
Primary outcome
Difference in BMI Z-score, Based on WHO Growth Standards
Time frame: 1-year
BMI values will be obtained from Geisinger clinical care visits, documented in the EHR and standardized or parent-reported. Values obtained at well child visits during the study period, ideally 12 months, 1 day apart will be utilized but values within a 9- to 18-month span of baseline to 1-year follow up may be used (e.g., 3 months pre-baseline WCV to 15 months post-baseline, baseline WCV to 18-months post-baseline, etc.) to assess the primary outcome. A z-score of 0 represents the population mean. Higher z-scores represent worse outcomes. BMI z-score over >=1 indicates possible risk for overweight.
3 secondary outcomes
United States Household Food Security Survey Module: Six-Item Short Form
Time frame: 1-year
Modified Version of Perceived Involvement in Care Scale
Time frame: 1-year
Food Resource Management
Time frame: 1-year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22799481Slusser W, Frankel F, Robison K, Fischer H, Cumberland WG, Neumann C. Pediatric overweight prevention through a parent training program for 2-4 year old Latino children. Child Obes. 2012 Feb;8(1):52-9. doi: 10.1089/chi.2011.0060.
- Background: PubMed 31275595Bailey-Davis L, Kling SMR, Wood GC, Cochran WJ, Mowery JW, Savage JS, Stametz RA, Welk GJ. Feasibility of enhancing well-child visits with family nutrition and physical activity risk assessment on body mass index. Obes Sci Pract. 2019 Apr 24;5(3):220-230. doi: 10.1002/osp4.339. eCollection 2019 Jun.
- Background: PubMed 36572870Bailey-Davis L, Moore AM, Poulsen MN, Dzewaltowski DA, Cummings S, DeCriscio LR, Hosterman JF, Huston D, Kirchner HL, Lutcher S, McCabe C, Welk GJ, Savage JS. Comparing enhancements to well-child visits in the prevention of obesity: ENCIRCLE cluster-randomized controlled trial. BMC Public Health. 2022 Dec 26;22(1):2429. doi: 10.1186/s12889-022-14827-w.
- Background: PubMed 38496791Potts BA, Wood GC, Bailey-Davis L. Agreement between parent-report and EMR height, weight, and BMI among rural children. Front Nutr. 2024 Mar 1;11:1279931. doi: 10.3389/fnut.2024.1279931. eCollection 2024.
- 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.
Lisa Bailey-Davis, DEd, RD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Reported Outcome Well Child Visit and Patient Reported Outcome Well Child Visit + Food Care in people with Pediatric Obesity and Preventive Medicine, run by Geisinger Clinic 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 8 inclusion and 3 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 5 Mar 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?
Yes. Results are posted in the registry (first posted 5 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference in BMI Z-score, Based on WHO Growth Standards (time frame: 1-year). 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 NCT04406441, which also lists 4 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 5 Mar 2025.