ObesityHHHKNCT01080885
Healthy Homes/Healthy Kids Preschool
A study testing Busy Bodies/Better Bites and Healthy Spots/Safe Tots in people with Obesity, run by HealthPartners Institute at 1 site in United States.
Trial summary
The goals of this study are to evaluate the feasibility, acceptability, and potential efficacy of an innovative obesity prevention intervention integrating pediatrician counseling and a home-based program to prevent unhealthy weight gain among 2-4 year old children at risk for obesity. Read more about this study
- Who is it for?
- Ages 2 to 4 years
- Conditions the study is for
- Obesity
- What is being tested?
- Busy Bodies/Better Bites and Healthy Spots/Safe Tots
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jul 2011
- 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 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- BMI between the 85th and 95th percentile for age and gender or
- BMI between the 50th and 85th percentile and at least one overweight parent (BMI ≥ 25 kg/m2)
- 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 a chromosomal abnormality such as Down's syndrome or Turner's syndrome.
- Children who within the last six months or who those who are currently taking the following medications and took them or will be taking them for more than a month: Prednisone, Prednisolone and Decadron.
- Families who have limited English skills.
- Families who plan to move out of the metropolitan area within the next six months.
Trial locations and contacts
1 site in 1 country.
United States1 site
HealthPartners Research Foundation
Bloomington, Minnesota, 55425
About this study
Official title: Linking Home Environments and Primary Care: Obesity Prevention for 2-5 Year Olds
The goals of this study are to evaluate the feasibility, acceptability, and potential efficacy of an innovative obesity prevention intervention integrating pediatrician counseling and a home-based program to prevent unhealthy weight gain among 2-4 year old children at risk for obesity.
Read the detailed description
The pediatric primary care setting is a relatively untapped resource for addressing obesity prevention. The goals of this developmental study are to develop and evaluate the feasibility and acceptability of a primary care-based, preschool obesity prevention intervention integrating pediatrician counseling and a home-based program for parents of 2-4 year old children at risk for obesity. We propose to recruit 60 parent-child dyads from families of 2-4 year old at risk children (e.g., BMI between the 85th and 95th percentile for age and gender or a BMI between the 50th and 85th percentile and at least one overweight parent) and randomize each dyad to one of the following groups: (a) Healthy Eating/Physical Activity Intervention including brief pediatrician counseling regarding the child's current BMI%ile status, recommendations for home environmental changes to achieve a healthy weight gain trajectory, and home safety and injury risk reduction recommendations paired with a 6 month home-based program delivered via phone by a health behavior specialist to promote implementation of the obesity prevention home environmental strategies, or (b) General Health/Safety/Injury Prevention Contact Control Intervention: Families will receive the same brief counseling from their pediatrician paired with a 6 month home-based program delivered via phone by a health behavior specialist to promote implementation of the general health, safety and injury prevention home environmental strategies.
- Healthy Eating/Physical Activity Home-based Intervention: The "Busy Bodies/Better Bites" 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 6 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: The "Healthy Tots/Safe Spots" intervention arm will include the same brief counseling from the pediatrician paired with a 6 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.
- Conditions
- Obesity
- Being tested
- Busy Bodies/Better Bites, Healthy Spots/Safe Tots
- Keywords
- Prevention, Prevention of unhealthy weight gain
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Busy Bodies/Better BitesBehavioural
This intervention will include brief counseling from the pediatrician paired with a 6 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the healthy eating and physical activity home environmental strategies.
Healthy Spots/Safe TotsBehavioural
This intervention will include the same brief counseling from the pediatrician paired with a 6 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 |
|---|---|---|
| Busy Bodies/Better Bites | Experimental | Healthy Eating/Physical Activity Intervention Receives: Behavioral: Busy Bodies/Better Bites |
| Healthy Spots/Safe Tots | Active comparator | Injury Prevention and Safety Intervention Receives: Behavioral: Healthy Spots/Safe Tots |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent and pediatrician participation and satisfaction
Parents of at risk preschool children and pediatricians will show high participation rates in and report high levels of satisfaction with the interventions.
Measured: 6 months
Healthy Eating
Healthy Eating/Physical Activity Home-based Intervention participants will show lower levels of sweetened beverage and higher levels of lower fat/calorie snack and meal consumption compared to Safety/Injury Prevention Home-based Contact Control Intervention participants. The Nutrition Data System for Research will be used to measure this change.
Measured: 6 months
Levels of TV watching
Healthy Eating/Physical Activity Home-based Intervention participants will show lower levels of TV watching compared to Safety/Injury Prevention Home-based Contact Control Intervention participants;
Measured: 6 months
Physical activity levels
Healthy Eating/Physical Activity Home-based Intervention participants will show higher levels of physical activity compared to Safety/Injury Prevention Home-based Contact Control Intervention participants. Physical activity level will be measured by accelerometry.
Measured: 6 months
Secondary outcomes (2)
Hypothesized mediators of BMI change
Parents in the Healthy Eating/Physical Activity Home-based Intervention will report more favorable levels of hypothesized mediators of BMI change (e.g., family meal frequency, availability of lower fat/calorie foods and physical activity opportunities) compared to Safety/Injury Prevention Home-based Contact Control Intervention participants.
Measured: 6 months
Body mass index (BMI) percentile
Participation in the Healthy Eating/Physical Activity Home-based Intervention will lead to reduced BMI percentile compared to Safety/Injury Prevention Home-based Contact Control Intervention participant.
Measured: 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 Mar 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2011
- Study completionJul 2011
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.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy E Sherwood, PhD, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080885
- Sponsor's protocol ID
- 08-149
- Other IDs
- R21DK078239-01A2
- Acronym
- HHHK
- Status last verified
- Apr 2012
- First submitted
- 3 Mar 2010
- Last updated
- 23 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Home Environments and Primary Care: Obesity Prevention for 2-5 Year Olds
- ClinicalTrials.gov ID
- NCT01080885
- Acronym / sponsor ID
- HHHK / 08-149
- Conditions
- Obesity
- Keywords
- Prevention, Prevention of unhealthy weight gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 4 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 goals of this study are to evaluate the feasibility, acceptability, and potential efficacy of an innovative obesity prevention intervention integrating pediatrician counseling and a home-based program to prevent unhealthy weight gain among 2-4 year old children at risk for obesity.
Detailed description
The pediatric primary care setting is a relatively untapped resource for addressing obesity prevention. The goals of this developmental study are to develop and evaluate the feasibility and acceptability of a primary care-based, preschool obesity prevention intervention integrating pediatrician counseling and a home-based program for parents of 2-4 year old children at risk for obesity. We propose to recruit 60 parent-child dyads from families of 2-4 year old at risk children (e.g., BMI between the 85th and 95th percentile for age and gender or a BMI between the 50th and 85th percentile and at least one overweight parent) and randomize each dyad to one of the following groups: (a) Healthy Eating/Physical Activity Intervention including brief pediatrician counseling regarding the child's current BMI%ile status, recommendations for home environmental changes to achieve a healthy weight gain trajectory, and home safety and injury risk reduction recommendations paired with a 6 month home-based program delivered via phone by a health behavior specialist to promote implementation of the obesity prevention home environmental strategies, or (b) General Health/Safety/Injury Prevention Contact Control Intervention: Families will receive the same brief counseling from their pediatrician paired with a 6 month home-based program delivered via phone by a health behavior specialist to promote implementation of the general health, safety and injury prevention home environmental strategies.
- Healthy Eating/Physical Activity Home-based Intervention: The "Busy Bodies/Better Bites" 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 6 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: The "Healthy Tots/Safe Spots" intervention arm will include the same brief counseling from the pediatrician paired with a 6 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 |
|---|---|---|
| Busy Bodies/Better Bites | Experimental | Behavioral: Busy Bodies/Better BitesHealthy Eating/Physical Activity Intervention |
| Healthy Spots/Safe Tots | Active comparator | Behavioral: Healthy Spots/Safe TotsInjury Prevention and Safety Intervention |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- BMI between the 85th and 95th percentile for age and gender or
- BMI between the 50th and 85th percentile and at least one overweight parent (BMI ≥ 25 kg/m2)
- 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 a chromosomal abnormality such as Down's syndrome or Turner's syndrome.
- Children who within the last six months or who those who are currently taking the following medications and took them or will be taking them for more than a month: Prednisone, Prednisolone and Decadron.
- Families who have limited English skills.
- Families who plan to move out of the metropolitan area within the next six months.
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 |
|---|---|---|
| Busy Bodies/Better BitesThis intervention will include brief counseling from the pediatrician paired with a 6 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the healthy eating and physical activity home environmental strategies. | Behavioural | Busy Bodies/Better Bites |
| Healthy Spots/Safe TotsThis intervention will include the same brief counseling from the pediatrician paired with a 6 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 | Healthy Spots/Safe Tots |
Primary outcome
Parent and pediatrician participation and satisfaction
Time frame: 6 months
Parents of at risk preschool children and pediatricians will show high participation rates in and report high levels of satisfaction with the interventions.
Healthy Eating
Time frame: 6 months
Healthy Eating/Physical Activity Home-based Intervention participants will show lower levels of sweetened beverage and higher levels of lower fat/calorie snack and meal consumption compared to Safety/Injury Prevention Home-based Contact Control Intervention participants. The Nutrition Data System for Research will be used to measure this change.
Levels of TV watching
Time frame: 6 months
Healthy Eating/Physical Activity Home-based Intervention participants will show lower levels of TV watching compared to Safety/Injury Prevention Home-based Contact Control Intervention participants;
Physical activity levels
Time frame: 6 months
Healthy Eating/Physical Activity Home-based Intervention participants will show higher levels of physical activity compared to Safety/Injury Prevention Home-based Contact Control Intervention participants. Physical activity level will be measured by accelerometry.
2 secondary outcomes
Hypothesized mediators of BMI change
Time frame: 6 months
Body mass index (BMI) percentile
Time frame: 6 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 23 Apr 2012.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Busy Bodies/Better Bites and Healthy Spots/Safe Tots in people with Obesity, run by HealthPartners Institute 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 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 23 Apr 2012. 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?
Parent and pediatrician participation and satisfaction (time frame: 6 months). The study lists 4 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 23 Apr 2012.