Childhood ObesityNCT03487614
Evaluation of a Primary Care Weight Management Program in Children Aged 2 to 5 Years
A study testing Behavior-based parental intervention in people with Childhood Obesity and Feeding Behavior, run by Corewell Health West.
Trial summary
Primary care offers a promising setting for promoting parenting practices that shape healthy eating and physical activity behaviors of young children. This study assessed the impact of a parent-based, primary care intervention on the feeding habits, health behaviors, and body mass index (BMI) of 2-5 year olds with… Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Childhood Obesity, Feeding Behavior, Physical Activity
- What is being tested?
- Behavior-based parental intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2014to 1 May 2023
- 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
- No healthy volunteers
- Child
Who may be able to join
- Age between 2 and 5 years
- BMI ≥85th percentile for age and sex, using the 2000 CDC growth chart, or BMI percentile increase within the past year equivalent to crossing at least two growth chart lines per year on a standard CDC growth chart, excluding the 5th percentile (e.g., 10th \& 25th, 25th \& 50th, 50th \& 75th, 75th \& 85th). This rate of increase is equivalent to ≥0.67 standard deviations per year (BMI z-score), and, when occurring in this age group, has been shown to increase risk of adult obesity
Who cannot join
- Known disorder of the HPA axis
- Use of glucocorticoid medication
- Non-English speaking
About this study
Official title: Evaluation of a Primary Care Weight Management Program in Children Aged 2 to 5 Years: Changes in Feeding Practices, Health Behaviors, and Adiposity
Primary care offers a promising setting for promoting parenting practices that shape healthy eating and physical activity behaviors of young children. This study assessed the impact of a parent-based, primary care intervention on the feeding habits, health behaviors, and body mass index (BMI) of 2-5 year olds with elevated or rapidly-increasing BMI. Four private pediatric offices in West Michigan were assigned as control (n=2) or intervention (n=2) sites based on patient load and demographics. Treatment families were recruited at well-child visits to receive physician health-behavior counseling and four visits with a registered dietitian nutritionist (RDN) over a 6-month period. Outcomes included percent of the 95th BMI percentile (%BMI95), the Family Nutrition and Physical Activity survey (FNPA), and the Feeding Practices and Structure Questionnaire (FPSQ).
- Conditions
- Childhood Obesity, Feeding Behavior, Physical Activity
- Being tested
- Behavior-based parental intervention
- Keywords
- pediatric obesity, preschool children, non-responsive feeding, body mass index, parenting
- Medical subject headings
- Pediatric Obesity, Feeding Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior-based parental interventionBehavioural
Behavioral intervention designed to promote healthy feeding behaviors in parents of 2-5 year olds, and to modify parenting practices in a way that encourages adequate physical activity, sufficient sleep, and healthy nutrition, while limiting sedentary behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Behavior-based parental intervention | Experimental | The study intervention included two primary components: 1) physician-family health behavior conversations during well-child visits, and 2) four monthly visits with a RDN to evaluate, educate, and implement improved feeding habits and nutritional choices. A third optional component of the intervention included counseling sessions with a social worker to help families overcome barriers to change, such as food security, family relationships, and general parenting strategies. Receives: Behavioral: Behavior-based parental intervention |
| Control | No intervention | Control parents signed the informed consent document and then completed all baseline assessments during their child's medical visit. Control participants then received their usual medical care. Follow-up evaluations, including child anthropometry and completion of study surveys were assessed approximately 6 months later during a second office visit. For children <3 years of age at baseline, follow up visits coincided with their subsequent well-child visit (i.e. 30-month or 3-year appointment) as per AAP visit frequency recommendations. For patients ≥3 years of age, families attended a separate office visit 6 months after their baseline visit in order to complete follow-up study assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometry
Age- and sex-specific body mass index such as percent of the 95th BMI percentile
Measured: Change from baseline to follow-up at 6 months
FNPA
Family Nutrition and Physical Activity screening tool
Measured: Change from baseline to follow-up at 6 months
FPSQ
Feeding Practices and Structure Questionnaire
Measured: Change from baseline to follow-up at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start1 Jul 2014
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- We Are for Children, LLC (WAFC), is a collaboration of non-profit pediatric practices in West Michigan formed to help members respond to healthcare needs. Four primary care pediatric offices from WAFC were selected to participate in the current study based on site interest and capacity. Participating pediatric offices were then matched into pairs based on similarities in office size (i.e. physician FTEs and patient load) and patient demographics characteristics, after which one of each matched pair was assigned as a treatment or control site.
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Care Network of Michigan, We Are For Children, LLC
- Responsible party
- Principal investigator, Jared Tucker, Corewell Health West
- Investigators
- Jared M Tucker, PhD, Principal investigator, Corewell Health West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487614
- Sponsor's protocol ID
- WAFC25
- Status last verified
- Jul 2023
- First submitted
- 21 Mar 2018
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing is a possibility upon approval from IRB.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Primary Care Weight Management Program in Children Aged 2 to 5 Years: Changes in Feeding Practices, Health Behaviors, and Adiposity
- ClinicalTrials.gov ID
- NCT03487614
- Acronym / sponsor ID
- WAFC25
- Conditions
- Childhood Obesity, Feeding Behavior, Physical Activity
- Keywords
- pediatric obesity, preschool children, non-responsive feeding, body mass index, parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Collaborators
- Blue Care Network of Michigan, We Are For Children, LLC
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 4 Apr 2018 (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.
Primary care offers a promising setting for promoting parenting practices that shape healthy eating and physical activity behaviors of young children. This study assessed the impact of a parent-based, primary care intervention on the feeding habits, health behaviors, and body mass index (BMI) of 2-5 year olds with elevated or rapidly-increasing BMI. Four private pediatric offices in West Michigan were assigned as control (n=2) or intervention (n=2) sites based on patient load and demographics. Treatment families were recruited at well-child visits to receive physician health-behavior counseling and four visits with a registered dietitian nutritionist (RDN) over a 6-month period. Outcomes included percent of the 95th BMI percentile (%BMI95), the Family Nutrition and Physical Activity survey (FNPA), and the Feeding Practices and Structure Questionnaire (FPSQ).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We Are for Children, LLC (WAFC), is a collaboration of non-profit pediatric practices in West Michigan formed to help members respond to healthcare needs. Four primary care pediatric offices from WAFC were selected to participate in the current study based on site interest and capacity. Participating pediatric offices were then matched into pairs based on similarities in office size (i.e. physician FTEs and patient load) and patient demographics characteristics, after which one of each matched pair was assigned as a treatment or control site.
| Arm | Type | Receives |
|---|---|---|
| Behavior-based parental intervention | Experimental | Behavioral: Behavior-based parental interventionThe study intervention included two primary components: 1) physician-family health behavior conversations during well-child visits, and 2) four monthly visits with a RDN to evaluate, educate, and implement improved feeding habits and nutritional choices. A third optional component of the intervention included counseling sessions with a social worker to help families overcome barriers to change, such as food security, family relationships, and general parenting strategies. |
| Control | No intervention | –Control parents signed the informed consent document and then completed all baseline assessments during their child's medical visit. Control participants then received their usual medical care. Follow-up evaluations, including child anthropometry and completion of study surveys were assessed approximately 6 months later during a second office visit. For children <3 years of age at baseline, follow up visits coincided with their subsequent well-child visit (i.e. 30-month or 3-year appointment) as per AAP visit frequency recommendations. For patients ≥3 years of age, families attended a separate office visit 6 months after their baseline visit in order to complete follow-up study assessments. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age between 2 and 5 years
- BMI ≥85th percentile for age and sex, using the 2000 CDC growth chart, or BMI percentile increase within the past year equivalent to crossing at least two growth chart lines per year on a standard CDC growth chart, excluding the 5th percentile (e.g., 10th \& 25th, 25th \& 50th, 50th \& 75th, 75th \& 85th). This rate of increase is equivalent to ≥0.67 standard deviations per year (BMI z-score), and, when occurring in this age group, has been shown to increase risk of adult obesity
Key exclusion criteria (3 listed)
- Known disorder of the HPA axis
- Use of glucocorticoid medication
- Non-English speaking
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 |
|---|---|---|
| Behavior-based parental interventionBehavioral intervention designed to promote healthy feeding behaviors in parents of 2-5 year olds, and to modify parenting practices in a way that encourages adequate physical activity, sufficient sleep, and healthy nutrition, while limiting sedentary behaviors. | Behavioural | Behavior-based parental intervention |
Primary outcome
Anthropometry
Time frame: Change from baseline to follow-up at 6 months
Age- and sex-specific body mass index such as percent of the 95th BMI percentile
FNPA
Time frame: Change from baseline to follow-up at 6 months
Family Nutrition and Physical Activity screening tool
FPSQ
Time frame: Change from baseline to follow-up at 6 months
Feeding Practices and Structure Questionnaire
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 25 Jul 2023.
- Individual participant dataSharing planned: No. Data sharing is a possibility upon approval from IRB.
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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.
Jared M Tucker, PhD principal investigator
Corewell Health West
Questions about this trial
What is this clinical trial studying?
A study testing Behavior-based parental intervention in people with Childhood Obesity and Feeding Behavior, run by Corewell Health West.
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 2 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 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Anthropometry (time frame: Change from baseline to follow-up at 6 months). The study lists 3 primary outcomes in all. 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 25 Jul 2023.