Childhood ObesityHFNCT01193374
The Healthy Families Project
A study testing Clinician enhanced screening and counseling prompts, Tailored education and motivational materials and basic educational brochure in people with Childhood Obesity, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
Trial summary
A primary care approach to obesity prevention will be developed and tested in a randomized trial in 4 pediatric primary care practices. Enhanced screening for obesity risks and prompts for effective counseling at well visits of 4 to 10 year olds will be developed utilizing hand held technology( PDAs). Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Clinician enhanced screening and counseling prompts, Tailored education and motivational materials and basic educational brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2007to Aug 2009
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Families with children ages 4 to 11 years
- For post visit supports; Children > 85% for age BMI
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001
Dartmouth Medical School, Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001
About this study
Official title: Promoting Healthy Families Through Enhanced Primary Care
A primary care approach to obesity prevention will be developed and tested in a randomized trial in 4 pediatric primary care practices. Enhanced screening for obesity risks and prompts for effective counseling at well visits of 4 to 10 year olds will be developed utilizing hand held technology( PDAs). The impact on the content and quality of clinician counseling will be assessed in exit survey prior to and after implementation. Among families interested in making a change to address nutrition or activity risk reported on the screener a cohort with children > BMI 85% will be recruited. They will be randomized to mailed tailored supports to level of readiness to change versus a single generic informational mailing. The hypotheses are that 1)families that receive the enhanced office visit with screening will be more likely to plan to make changes compared to usual care; and 2) families receiving the tailored post visit supports will be less likely to gain weight than controls after 6 months.
Read the detailed description
- Using hand held PDAs, we will develop an obesity risk screening and counseling system for 4 through 10 year olds attending primary care well child visits. Screening results will be summarized immediately by the PDA and will prompt the clinician to provide brief counseling messages tailored to each childís obesity screening results, including the familyís and the childís readiness to change behavior
- We will evaluate the specific content and quality of clinician obesity counseling provided at the well child visit through parent surveys before and after implementation of the PDA screening and counseling program.
- To support action by families after the office visit, we will develop a post-visit intervention package of newsletters and materials that are tailored to child/family obesity risk behaviors and parental readiness to change.
- We will evaluate the impact of this post visit intervention program in a 6 month trial focused on children identified at well child screening to have BMI >85%. 200 Families will be randomized to receive either a series of mailed supports over 3 months versus a single generic-content mailing. We will determine the respective impact of these two levels of post-visit support on stage of change, parental action on key obesity risk behaviors, and stabilization of BMI z scores after 6 months.
- Conditions
- Childhood Obesity
- Being tested
- Clinician enhanced screening and counseling prompts, Tailored education and motivational materials, basic educational brochure
- Keywords
- Childhood Obesity, Primary Care, Counseling, Screening
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinician enhanced screening and counseling promptsBehavioural
Also called All subjects receive screening/counseling
PDA based health risk screening for well child issues and obesity risks
Tailored education and motivational materialsBehavioural
Also called Well child care intervention
Specific tailoring for those interested in change vs not . Two newsletters over 3 mpn.
basic educational brochureBehavioural
Also called Education
Booklet by ADA sent x 1.
| Study group | Role | What they receive |
|---|---|---|
| Parent/child tailored mailed materials | Experimental | Family provided newsletters tailored to issues and readiness to change. Family receives educational nutrition DVD, pedometers for family activities and child nutrition/physical activity games Receives: Behavioral: Clinician enhanced screening and counseling prompts; Behavioral: Tailored education and motivational materials |
| Basic information at single time | Active comparator | Family provided with high quality booklet from American Dietetic Association providing the same information that intervention arm received but not tailored. Receives: Behavioral: Clinician enhanced screening and counseling prompts; Behavioral: basic educational brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI z score
Prevention of increase in BMI
Measured: 6 months
Secondary outcomes (1)
Parental readiness to initiate change
Exit surveys comparing parents with PDA screening vs not for readiness to make changes
Measured: immediately post well visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startFeb 2007
- Primary completionMar 2008
- Study completionAug 2009
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Ardis L Olson, MD, Principal investigator, Dartmouth Medical School, Dept. of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193374
- Sponsor's protocol ID
- R21HD050996
- Acronym
- HF
- Status last verified
- May 2011
- First submitted
- 31 Aug 2010
- Last updated
- 24 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Healthy Families Through Enhanced Primary Care
- ClinicalTrials.gov ID
- NCT01193374
- Acronym / sponsor ID
- HF / R21HD050996
- Conditions
- Childhood Obesity
- Keywords
- Childhood Obesity, Primary Care, Counseling, Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Feb 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 1 Sep 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.
A primary care approach to obesity prevention will be developed and tested in a randomized trial in 4 pediatric primary care practices. Enhanced screening for obesity risks and prompts for effective counseling at well visits of 4 to 10 year olds will be developed utilizing hand held technology( PDAs). The impact on the content and quality of clinician counseling will be assessed in exit survey prior to and after implementation. Among families interested in making a change to address nutrition or activity risk reported on the screener a cohort with children > BMI 85% will be recruited. They will be randomized to mailed tailored supports to level of readiness to change versus a single generic informational mailing. The hypotheses are that 1)families that receive the enhanced office visit with screening will be more likely to plan to make changes compared to usual care; and 2) families receiving the tailored post visit supports will be less likely to gain weight than controls after 6 months.
Detailed description
- Using hand held PDAs, we will develop an obesity risk screening and counseling system for 4 through 10 year olds attending primary care well child visits. Screening results will be summarized immediately by the PDA and will prompt the clinician to provide brief counseling messages tailored to each childís obesity screening results, including the familyís and the childís readiness to change behavior
- We will evaluate the specific content and quality of clinician obesity counseling provided at the well child visit through parent surveys before and after implementation of the PDA screening and counseling program.
- To support action by families after the office visit, we will develop a post-visit intervention package of newsletters and materials that are tailored to child/family obesity risk behaviors and parental readiness to change.
- We will evaluate the impact of this post visit intervention program in a 6 month trial focused on children identified at well child screening to have BMI >85%. 200 Families will be randomized to receive either a series of mailed supports over 3 months versus a single generic-content mailing. We will determine the respective impact of these two levels of post-visit support on stage of change, parental action on key obesity risk behaviors, and stabilization of BMI z scores after 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent/child tailored mailed materials | Experimental | Behavioral: Clinician enhanced screening and counseling prompts, Behavioral: Tailored education and motivational materialsFamily provided newsletters tailored to issues and readiness to change. Family receives educational nutrition DVD, pedometers for family activities and child nutrition/physical activity games |
| Basic information at single time | Active comparator | Behavioral: Clinician enhanced screening and counseling prompts, Behavioral: basic educational brochureFamily provided with high quality booklet from American Dietetic Association providing the same information that intervention arm received but not tailored. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Families with children ages 4 to 11 years
- For post visit supports; Children > 85% for age BMI
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Clinician enhanced screening and counseling promptsAlso: All subjects receive screening/counselingPDA based health risk screening for well child issues and obesity risks | Behavioural | Basic information at single time, Parent/child tailored mailed materials |
| Tailored education and motivational materialsAlso: Well child care interventionSpecific tailoring for those interested in change vs not . Two newsletters over 3 mpn. | Behavioural | Parent/child tailored mailed materials |
| basic educational brochureAlso: EducationBooklet by ADA sent x 1. | Behavioural | Basic information at single time |
Primary outcome
BMI z score
Time frame: 6 months
Prevention of increase in BMI
1 secondary outcome
Parental readiness to initiate change
Time frame: immediately post well visit
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 24 May 2011.
Related trials for Childhood Obesity
Enrolling by invitation
Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
Pediatric Obesity, Childhood Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
Quality of Life (QOL), Nutrition
RecruitingPhase 3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Obesity, Childhood, Insulin Resistance
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.
Ardis L Olson, MD principal investigator
Dartmouth Medical School, Dept. of Pediatrics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinician enhanced screening and counseling prompts, Tailored education and motivational materials and basic educational brochure in people with Childhood Obesity, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 0 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 24 May 2011. 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 z score (time frame: 6 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 24 May 2011; AzTrials last refreshed its copy on 1 Nov 2026.