Childhood ObesityHHSNCT02703688
Environmental Influences on Early Childhood Obesity
A study testing Healthy Homes in people with Childhood Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Few treatments have been developed for young children with obesity from diverse backgrounds. The present study will develop and test an intervention designed to improve preschool obesity in Latino children. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Healthy Homes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2011to 31 Mar 2014
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- mothers will identify themselves as being Latino
- obese preschool children will be required to have a BMI percentile at or above the 95th percentile, based on sex specific, BMI-for-age population referenced growth charts
- participating children will be required to have at least one primary caregiver who is English-speaking as their primary language and live within 50 miles of the UCD for the initial treatment development phase (n=3) and at least one family who is Spanish speaking (n=1). However, all families participating in the randomized portion can also be exclusively Spanish speaking.
Who cannot join
- Children with medical conditions known to promote obesity will be excluded along with individuals involved with a weight-control program or those taking appetite-affecting medications
- Children who are greater than 100% overweight
- Children will be excluded who have a reported disability, illness, or disorder that would significantly affect diet or activity behaviors
- children identified by parents with significant food allergies
- involvement with Stage II, structured weight management for obesity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Environmental Influences on Early Childhood Obesity: The Healthy Homes Study
Few treatments have been developed for young children with obesity from diverse backgrounds. The present study will develop and test an intervention designed to improve preschool obesity in Latino children. The intervention will focus on improving eating, activity, and sleep behaviors and the home environment for improved weight status.
Read the detailed description
Children from low income families of minority status are at greater risk for development of obesity. There are no known existing treatments for pediatric obesity that focus on improving parental behaviors and the home food and activity environment. The objective of this study will be to address this limitation by developing and testing a novel treatment for low-income minority families. The objective will be attained by testing the following hypothesis: A parent-focused, home-based treatment aimed at improving parental feeding behaviors, child exposure to fruits and vegetables, and the home food and activity environment will result in significantly greater decrease in percent overweight / obesity compared to recommended practice. The hypothesis will be tested by using the approach of a pilot randomized control trial (RCT). The rationale for this aim is that success of the planned research will derive a treatment package that will provide the basis for the RCT. The planned research is expected to show the level of impact of changing parental feeding behaviors and the home environment on childhood overweight / obesity.
- Conditions
- Childhood Obesity
- Being tested
- Healthy Homes, Usual 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.
Healthy HomesBehavioural
The Healthy Homes Behavioral Intervention (HHBI) will be delivered during 8 sessions over 10 weeks using home visitations. The first 6 sessions occur weekly and provide education about healthy dietary intake including caloric recommendations for preschool aged children, healthy sleep goals, active play and screen time limits, and family routines and organization. Each session will include a parent-child interaction component to teach child behavior management skills related to intervention goals. Two final sessions occur every other week to provide problem solving and planning for maintenance of treatment effects.
Usual CareOther
A pediatrician with experience delivering weight management treatment to children will deliver a single session, 1-hour treatment to families. Content to be delivered during the session will include lifestyle recommendations currently recommended by the AAP.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Homes | Experimental | Behavioral Intervention Receives: Behavioral: Healthy Homes |
| Usual Care | Active comparator | Counseling session delivered by pediatrician Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI
BMI and % over the 95th percentile will be determined using scales
Measured: Baseline, 2.5 months, 12 months
Secondary outcomes (5)
Change in Caregiver's Feeding Styles Questionnaire
Change in type of parental feeding style over time
Measured: Baseline, 2.5 months, 12 months
Change in Child caloric intake
24 hour dietary recall will identify average daily caloric intake
Measured: Baseline, 2.5 months, 12 months
Change in Sleep duration
Accelerometer will be used to determine objective estimates of sleep duration
Measured: Baseline, 2.5 months, 12 months
Change in Home sleep environment
change in sleeping environment characteristics that promote healthy sleep
Measured: Baseline, 2.5 months, 12 months
Change in Home food environment
change in home food environment characteristics that promote healthy food intake.
Measured: Baseline, 2.5 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study start15 Sep 2011
- Primary completion31 Mar 2014
- Study completion31 Mar 2014
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.
- More trials run by University of Colorado, DenverThe 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
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard E Boles, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703688
- Sponsor's protocol ID
- 14-1975
- Other IDs
- K23DK087826
- Acronym
- HHS
- Status last verified
- Jul 2022
- First submitted
- 22 Feb 2016
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Influences on Early Childhood Obesity: The Healthy Homes Study
- ClinicalTrials.gov ID
- NCT02703688
- Acronym / sponsor ID
- HHS / 14-1975
- Conditions
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Sep 2011 (actual)
- Primary completion
- 31 Mar 2014 (actual)
- Study completion
- 31 Mar 2014 (actual)
- First posted
- 9 Mar 2016 (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.
Few treatments have been developed for young children with obesity from diverse backgrounds. The present study will develop and test an intervention designed to improve preschool obesity in Latino children. The intervention will focus on improving eating, activity, and sleep behaviors and the home environment for improved weight status.
Detailed description
Children from low income families of minority status are at greater risk for development of obesity. There are no known existing treatments for pediatric obesity that focus on improving parental behaviors and the home food and activity environment. The objective of this study will be to address this limitation by developing and testing a novel treatment for low-income minority families. The objective will be attained by testing the following hypothesis: A parent-focused, home-based treatment aimed at improving parental feeding behaviors, child exposure to fruits and vegetables, and the home food and activity environment will result in significantly greater decrease in percent overweight / obesity compared to recommended practice. The hypothesis will be tested by using the approach of a pilot randomized control trial (RCT). The rationale for this aim is that success of the planned research will derive a treatment package that will provide the basis for the RCT. The planned research is expected to show the level of impact of changing parental feeding behaviors and the home environment on childhood overweight / obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Homes | Experimental | Behavioral: Healthy HomesBehavioral Intervention |
| Usual Care | Active comparator | Other: Usual CareCounseling session delivered by pediatrician |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- mothers will identify themselves as being Latino
- obese preschool children will be required to have a BMI percentile at or above the 95th percentile, based on sex specific, BMI-for-age population referenced growth charts
- participating children will be required to have at least one primary caregiver who is English-speaking as their primary language and live within 50 miles of the UCD for the initial treatment development phase (n=3) and at least one family who is Spanish speaking (n=1). However, all families participating in the randomized portion can also be exclusively Spanish speaking.
Key exclusion criteria (5 listed)
- Children with medical conditions known to promote obesity will be excluded along with individuals involved with a weight-control program or those taking appetite-affecting medications
- Children who are greater than 100% overweight
- Children will be excluded who have a reported disability, illness, or disorder that would significantly affect diet or activity behaviors
- children identified by parents with significant food allergies
- involvement with Stage II, structured weight management for obesity.
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 |
|---|---|---|
| Healthy HomesThe Healthy Homes Behavioral Intervention (HHBI) will be delivered during 8 sessions over 10 weeks using home visitations. The first 6 sessions occur weekly and provide education about healthy dietary intake including caloric recommendations for preschool aged children, healthy sleep goals, active play and screen time limits, and family routines and organization. Each session will include a parent-child interaction component to teach child behavior management skills related to intervention goals. Two final sessions occur every other week to provide problem solving and planning for maintenance of treatment effects. | Behavioural | Healthy Homes |
| Usual CareA pediatrician with experience delivering weight management treatment to children will deliver a single session, 1-hour treatment to families. Content to be delivered during the session will include lifestyle recommendations currently recommended by the AAP. | Other | Usual Care |
Primary outcome
Change in BMI
Time frame: Baseline, 2.5 months, 12 months
BMI and % over the 95th percentile will be determined using scales
5 secondary outcomes
Change in Caregiver's Feeding Styles Questionnaire
Time frame: Baseline, 2.5 months, 12 months
Change in Child caloric intake
Time frame: Baseline, 2.5 months, 12 months
Change in Sleep duration
Time frame: Baseline, 2.5 months, 12 months
Change in Home sleep environment
Time frame: Baseline, 2.5 months, 12 months
Change in Home food environment
Time frame: Baseline, 2.5 months, 12 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 15 Jul 2022.
- 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.
Richard E Boles, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Homes in people with Childhood Obesity, run by University of Colorado, Denver 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 3 inclusion and 5 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 15 Jul 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. 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?
Change in BMI (time frame: Baseline, 2.5 months, 12 months). 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 15 Jul 2022.