ObesityHHHK_5-9NCT01084590
Healthy Homes/Healthy Kids_5-9
A study testing Healthy Eating/Physical Activity and Safety/Injury Prevention in people with Obesity and Injury, run by HealthPartners Institute at 2 sites in United States.
Trial summary
The pediatric primary care setting is a relatively untapped resource for addressing obesity prevention. The main goal of this study is to evaluate the efficacy of a relatively low cost pediatric primary-care based obesity prevention intervention. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- What is being tested?
- Healthy Eating/Physical Activity and Safety/Injury Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 421 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2010to Oct 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 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- BMI%ile between the 75th and 95th%ile
- Receives care at a HealthPartners Clinic in the Twin Cities Metropolitan Area
Who cannot join
- Children with the following chronic conditions: kidney disease, Type 1 diabetes, lupus, a thyroid condition, cancer, or chromosomal abnormality such as Down's syndrome or Turner's syndrome
- Children who within the last six months or those who are currently taking the following medications and took them or will be taking them for more than a month: Prednisone, Prednisilone, and Decadron.
- Families who have limited English skills.
- Families who plan to move out of the metropolitan area within the next two years.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
HealthPartners Research Foundation
Bloomington, Minnesota, 55425
University of Washington School of Social Work
Seattle, Washington, 98105
About this study
Official title: Healthy Homes/Healthy Kids: Pediatric Primary Care-based Obesity Prevention
The pediatric primary care setting is a relatively untapped resource for addressing obesity prevention. The main goal of this study is to evaluate the efficacy of a relatively low cost pediatric primary-care based obesity prevention intervention. The intervention will consist of brief pediatrician counseling as well as phone coaching for parents with overweight children who are between the ages of five and nine. We propose to enroll and randomize 425 parent-child dyads with children who have a measured body mass index (BMI) the 75th and 95th percentile. They will be randomized one of into two groups, the (a) Healthy Eating/Physical Activity Intervention, or the (b) General Healthy/Safety/Injury Prevention Contact Control Intervention. Both groups will receive brief pediatrician counseling regarding their child's current BMI percentile status and recommendations for home environmental changes to achieve a healthy weight gain trajectory and to improve home safety and reduce injury risk. This will be paired with a 12 month home-based program delivered via phone by health behavior specialists to help parents make environmental changes specific to their group assignment.
Read the detailed description
The goal of this study is to evaluate the efficacy of a relatively low cost pediatric primary-care based intervention that integrates brief pediatric counseling and a home-based phone program to prevent unhealthy weight gain in overweight children ages five-nine. Parent-child dyads will be recruited for the Healthy Homes/Healthy Kids Study via a multi-step process including use of electronic medical record data to identify children, pediatrician approval, and outreach via letters and phone calls. Four hundred and twenty five parent-child dyads from pediatric primary care will be recruited to participate and be randomized to one of two interventions:
Healthy Eating/Physical Activity Home-based Intervention: This intervention arm will include brief pediatrician counseling regarding the child's current BMI percentile status, recommendations for home environmental changes to achieve a healthy weight gain trajectory, and home safety and injury risk reduction environmental recommendations paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the obesity prevention home environmental strategies.
Safety/Injury Prevention Home-based Contact Control Intervention: This intervention arm will include the same brief counseling from the pediatrician paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the safety and injury prevention home environmental strategies.
- Being tested
- Healthy Eating/Physical Activity, Safety/Injury Prevention
- Keywords
- Prevention, Obesity, Safety, Unhealthy weight gain, Injury prevention
- Medical subject headings
- Obesity, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Eating/Physical ActivityBehavioural
This intervention arm will include brief pediatrician counseling regarding the child's current BMI percentile status, recommendations for home environmental changes to achieve a healthy weight gain trajectory, and home safety and injury risk reduction environmental recommendations paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the obesity prevention home environmental strategies.
Safety/Injury PreventionBehavioural
This intervention arm will include the same brief counseling from the pediatrician paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the safety and injury prevention home environmental strategies.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Eating/Physical Activity | Experimental | This intervention arm will include brief pediatrician counseling regarding the child's current BMI percentile status, recommendations for home environmental changes to achieve a healthy weight gain trajectory, and home safety and injury risk reduction environmental recommendations paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the obesity prevention home environmental strategies. Receives: Behavioral: Healthy Eating/Physical Activity |
| Safety/Injury Prevention | Active comparator | This intervention arm will include the same brief counseling from the pediatrician paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the safety and injury prevention home environmental strategies. Receives: Behavioral: Safety/Injury Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI percentile change
Children at risk for obesity (defined as having a BMI%ile between the 75th and 85th%ile) whose parent participates in the Healthy Eating/Physical Activity Intervention will have a significantly lower BMI percentile at 12 and 24 month-follow up when compared to children whose parents participated in the Safety/Injury Prevention Intervention.
Measured: 24 months
Secondary outcomes (4)
Dietary intake and activity patterns
Children whose parents are in the Healthy Eating/Physical Activity Home-based Intervention participants will exhibit more favorable dietary intake and activity patterns relative to children whose parents are in the Safety/Injury Prevention group
Measured: 24 months
Parenting behaviors
Parents who exhibit more parenting behaviors related to obesity prevention and higher overall adherence to pediatric primary care provider recommendations will be more successful in helping their child achieve a healthy weight gain trajectory.
Measured: 24 months
BMI percentile and psychosocial adjustment
A lower increase in BMI percentile will be associated with more favorable psychosocial adjustment and that there will be no increase in disordered eating in children with parents in the Healthy Eating/Physical Activity group relative to children with parents in in the Safety/Injury Prevention group
Measured: 24 months
Parent BMI
Parent attention to child weight and instruction to model healthy eating and physical activity behavior will impact parent weight, with the Healthy Eating/Physical Activity group parents having lower BMI relative to the Safety/Injury Prevention group parents.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2014
- Study completionOct 2014
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 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
- None (open label)
- Enrolment
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Washington, University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Nancy E Sherwood, PhD, Principal investigator, HealthPartners InstituteRona L Levy, PhD, Principal investigator, University of Washington School of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084590
- Sponsor's protocol ID
- A08-132
- Other IDs
- 1R01DK084475
- Acronym
- HHHK_5-9
- Status last verified
- Mar 2015
- First submitted
- 9 Mar 2010
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
JaKa MM, French SA, Wolfson J, Jeffery RW, Lorencatto F, Michie S, Levy RL, Langer SL, Sherwood NE. Understanding Outcomes in Behavior Change Interventions to Prevent Pediatric Obesity: The Role of Dose and Behavior Change Techniques. Health Educ Behav. 2019 Apr;46(2):312-321. doi: 10.1177/1090198118798679. Epub 2018 Sep 14.
PubMed 30215279Kunin-Batson AS, Seburg EM, Crain AL, Jaka MM, Langer SL, Levy RL, Sherwood NE. Household factors, family behavior patterns, and adherence to dietary and physical activity guidelines among children at risk for obesity. J Nutr Educ Behav. 2015 May-Jun;47(3):206-15. doi: 10.1016/j.jneb.2015.01.002. Epub 2015 Mar 4.
PubMed 25748634Sherwood NE, Levy RL, Langer SL, Senso MM, Crain AL, Hayes MG, Anderson JD, Seburg EM, Jeffery RW. Healthy Homes/Healthy Kids: a randomized trial of a pediatric primary care-based obesity prevention intervention for at-risk 5-10 year olds. Contemp Clin Trials. 2013 Sep;36(1):228-43. doi: 10.1016/j.cct.2013.06.017. Epub 2013 Jun 28.
PubMed 23816490
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Homes/Healthy Kids: Pediatric Primary Care-based Obesity Prevention
- ClinicalTrials.gov ID
- NCT01084590
- Acronym / sponsor ID
- HHHK_5-9 / A08-132
- Keywords
- Prevention, Obesity, Safety, Unhealthy weight gain, Injury prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Washington, University of Minnesota
- Study start
- Mar 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 10 Mar 2010 (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.
The pediatric primary care setting is a relatively untapped resource for addressing obesity prevention. The main goal of this study is to evaluate the efficacy of a relatively low cost pediatric primary-care based obesity prevention intervention. The intervention will consist of brief pediatrician counseling as well as phone coaching for parents with overweight children who are between the ages of five and nine. We propose to enroll and randomize 425 parent-child dyads with children who have a measured body mass index (BMI) the 75th and 95th percentile. They will be randomized one of into two groups, the (a) Healthy Eating/Physical Activity Intervention, or the (b) General Healthy/Safety/Injury Prevention Contact Control Intervention. Both groups will receive brief pediatrician counseling regarding their child's current BMI percentile status and recommendations for home environmental changes to achieve a healthy weight gain trajectory and to improve home safety and reduce injury risk. This will be paired with a 12 month home-based program delivered via phone by health behavior specialists to help parents make environmental changes specific to their group assignment.
Detailed description
The goal of this study is to evaluate the efficacy of a relatively low cost pediatric primary-care based intervention that integrates brief pediatric counseling and a home-based phone program to prevent unhealthy weight gain in overweight children ages five-nine. Parent-child dyads will be recruited for the Healthy Homes/Healthy Kids Study via a multi-step process including use of electronic medical record data to identify children, pediatrician approval, and outreach via letters and phone calls. Four hundred and twenty five parent-child dyads from pediatric primary care will be recruited to participate and be randomized to one of two interventions:
Healthy Eating/Physical Activity Home-based Intervention: This intervention arm will include brief pediatrician counseling regarding the child's current BMI percentile status, recommendations for home environmental changes to achieve a healthy weight gain trajectory, and home safety and injury risk reduction environmental recommendations paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the obesity prevention home environmental strategies.
Safety/Injury Prevention Home-based Contact Control Intervention: This intervention arm will include the same brief counseling from the pediatrician paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the safety and injury prevention home environmental strategies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Eating/Physical Activity | Experimental | Behavioral: Healthy Eating/Physical ActivityThis intervention arm will include brief pediatrician counseling regarding the child's current BMI percentile status, recommendations for home environmental changes to achieve a healthy weight gain trajectory, and home safety and injury risk reduction environmental recommendations paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the obesity prevention home environmental strategies. |
| Safety/Injury Prevention | Active comparator | Behavioral: Safety/Injury PreventionThis intervention arm will include the same brief counseling from the pediatrician paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the safety and injury prevention home environmental strategies. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- BMI%ile between the 75th and 95th%ile
- Receives care at a HealthPartners Clinic in the Twin Cities Metropolitan Area
Key exclusion criteria (4 listed)
- Children with the following chronic conditions: kidney disease, Type 1 diabetes, lupus, a thyroid condition, cancer, or chromosomal abnormality such as Down's syndrome or Turner's syndrome
- Children who within the last six months or those who are currently taking the following medications and took them or will be taking them for more than a month: Prednisone, Prednisilone, and Decadron.
- Families who have limited English skills.
- Families who plan to move out of the metropolitan area within the next two years.
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 Eating/Physical ActivityThis intervention arm will include brief pediatrician counseling regarding the child's current BMI percentile status, recommendations for home environmental changes to achieve a healthy weight gain trajectory, and home safety and injury risk reduction environmental recommendations paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the obesity prevention home environmental strategies. | Behavioural | Healthy Eating/Physical Activity |
| Safety/Injury PreventionThis intervention arm will include the same brief counseling from the pediatrician paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the safety and injury prevention home environmental strategies. | Behavioural | Safety/Injury Prevention |
Primary outcome
BMI percentile change
Time frame: 24 months
Children at risk for obesity (defined as having a BMI%ile between the 75th and 85th%ile) whose parent participates in the Healthy Eating/Physical Activity Intervention will have a significantly lower BMI percentile at 12 and 24 month-follow up when compared to children whose parents participated in the Safety/Injury Prevention Intervention.
4 secondary outcomes
Dietary intake and activity patterns
Time frame: 24 months
Parenting behaviors
Time frame: 24 months
BMI percentile and psychosocial adjustment
Time frame: 24 months
Parent BMI
Time frame: 24 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 27 Mar 2015.
- Derived from this study: PubMed 30215279JaKa MM, French SA, Wolfson J, Jeffery RW, Lorencatto F, Michie S, Levy RL, Langer SL, Sherwood NE. Understanding Outcomes in Behavior Change Interventions to Prevent Pediatric Obesity: The Role of Dose and Behavior Change Techniques. Health Educ Behav. 2019 Apr;46(2):312-321. doi: 10.1177/1090198118798679. Epub 2018 Sep 14.
- Derived from this study: PubMed 25748634Kunin-Batson AS, Seburg EM, Crain AL, Jaka MM, Langer SL, Levy RL, Sherwood NE. Household factors, family behavior patterns, and adherence to dietary and physical activity guidelines among children at risk for obesity. J Nutr Educ Behav. 2015 May-Jun;47(3):206-15. doi: 10.1016/j.jneb.2015.01.002. Epub 2015 Mar 4.
- Derived from this study: PubMed 23816490Sherwood NE, Levy RL, Langer SL, Senso MM, Crain AL, Hayes MG, Anderson JD, Seburg EM, Jeffery RW. Healthy Homes/Healthy Kids: a randomized trial of a pediatric primary care-based obesity prevention intervention for at-risk 5-10 year olds. Contemp Clin Trials. 2013 Sep;36(1):228-43. doi: 10.1016/j.cct.2013.06.017. Epub 2013 Jun 28.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Nancy E Sherwood, PhD principal investigator
HealthPartners Institute
Rona L Levy, PhD principal investigator
University of Washington School of Social Work
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Eating/Physical Activity and Safety/Injury Prevention in people with Obesity and Injury, run by HealthPartners Institute at 2 sites 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 2 inclusion and 4 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 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
BMI percentile change (time frame: 24 months). 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 NCT01084590, 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 27 Mar 2015.