ObesityNCT01625910
For the Health of Our Children--Clinic Based Treatment of Childhood Obesity
A study testing Behavioral counseling in people with Obesity, run by University of Minnesota at 2 sites in United States.
Trial summary
Childhood obesity is a major public health problem in the U.S. Currently approximately one in three children is considered overweight or obese. Most overweight children grow to become overweight adults. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Behavioral counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- any patient at the participating clinic between the ages of 4-8 years who have a BMI ≥ the 85th percentile
Who cannot join
- emergent health concern
- serious chronic health concern or recent gastrointestinal illness which may have resulted in weight loss
- on medications known to affect weight
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fairview Children's Clinic
Minneapolis, Minnesota, 55414
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
Official title: For the Health of Our Children--Clinic Based Treatment of Childhood Obesity: The Feasibility of Recruitment and the Effectiveness of a Low-intensity Stage
Childhood obesity is a major public health problem in the U.S. Currently approximately one in three children is considered overweight or obese. Most overweight children grow to become overweight adults. It is unclear how effective pediatricians and other primary care physicians can be in assisting overweight children to normalize their body weight. Expert guidelines have been established, but are currently untested.
This study will randomize overweight and obese children between the ages of 4 and 8 years old to either the recommended treatment guidelines or a control (non-intervention) group.
The purpose of this study is to evaluate the ability (a) to recruit overweight children between the ages of 4 and 8 years old (b) to remeasure the children three months after enrollment and (c) to reduce childhood obesity via implementation of the recommended treatment guidelines.
Read the detailed description
- Research Plan:
- Specific Aims and Hypothesis: In 2007, an expert committee, composed of representatives from 16 major clinical organizations (including the PI of this proposal), published recommendations for primary care office-based treatment of childhood obesity. Seeking both clinical and cost-effectiveness, the recommendations call for staged treatment that starts with low intensity, and then, if unsuccessful, increases to a higher frequency of visits. The committee acknowledged that this staged approach "has not been evaluated." Recent reviews conclude that treatment of childhood obesity can be efficacious. However, most studies were conducted in highly controlled tertiary care research settings and involved a large number of direct contact hours (e.g. many with ≥ 35 contact hours). Research evaluating the translation of these encouraging findings into more real-world clinical settings has been lacking. Specifically, there is little research assessing (1) the feasibility of recruitment from primary care clinics or (2) whether low intensity treatment (i.e. the initial phase of the staged approach recommended by the expert committee) has any benefit on weight loss.
- Aim #1: To assess the feasibility of recruiting overweight and obese children, ages 4-8 years, from a large, urban pediatric primary care clinic, randomizing them to either low-intensity treatment or a control group, and then re-measuring them at approximately 3-months from the date of recruitment.
- Our hypothesis is that we will be able to recruit approximately 70 parent/child dyads and re-measure 80% at 3-months.
- Aim #2: To evaluate whether the proportion of children who decrease their BMI z-score over a 3-month period is higher in those randomly assigned to the intervention group compared with those in the control group.
- Our hypothesis is that the intervention will result in a larger proportion of children decreasing BMI z-score over a 3-month period.
Results from Aims 1 and 2 will be used to plan for an NIH proposal. If the low intensity treatment of this proposal shows a trend toward improvement over usual care, this will justify a full scale, R01 trial testing the complete recommendations of the expert committee. If few subjects in the intervention group have decreasing BMI z-scores, then a smaller NIH trial would be needed to test an amended low-intensity treatment stage with more parent/child contact (e.g. emails, home visits, phone calls).
- Conditions
- Obesity
- Being tested
- Behavioral counseling
- Keywords
- Childhood obesity treatment, Motivational interviewing
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral counselingBehavioural
Also called Motivational Interviewing, Pediatric obesity treatment
Counseling of parents to improve their child's diet and physical activity
| Study group | Role | What they receive |
|---|---|---|
| behavioral counseling | Experimental | Receive counseling via motivational interviewing seeking to encourage health eating habits and increased physical activity Receives: Behavioral: Behavioral counseling |
| Instructions in school readiness and performance | Placebo comparator | Parents receive instructions in school readiness and performance Receives: Behavioral: Behavioral counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index Z-score Change
Change in body mass index z-score change over the three month time period
Measured: Three months
Secondary outcomes (1)
Sugar Sweetened Beverages
Change in reported intake of sugar sweetened beverages
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startSep 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven D Stovitz, MD, MS, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625910
- Sponsor's protocol ID
- 1107M02462
- Status last verified
- Jan 2017
- First submitted
- 10 Apr 2012
- Last updated
- 9 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- For the Health of Our Children--Clinic Based Treatment of Childhood Obesity: The Feasibility of Recruitment and the Effectiveness of a Low-intensity Stage
- ClinicalTrials.gov ID
- NCT01625910
- Acronym / sponsor ID
- 1107M02462
- Conditions
- Obesity
- Keywords
- Childhood obesity treatment, Motivational interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 22 Jun 2012 (estimated)
- Results
- Posted 6 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Childhood obesity is a major public health problem in the U.S. Currently approximately one in three children is considered overweight or obese. Most overweight children grow to become overweight adults. It is unclear how effective pediatricians and other primary care physicians can be in assisting overweight children to normalize their body weight. Expert guidelines have been established, but are currently untested.
This study will randomize overweight and obese children between the ages of 4 and 8 years old to either the recommended treatment guidelines or a control (non-intervention) group.
The purpose of this study is to evaluate the ability (a) to recruit overweight children between the ages of 4 and 8 years old (b) to remeasure the children three months after enrollment and (c) to reduce childhood obesity via implementation of the recommended treatment guidelines.
Detailed description
- Research Plan:
- Specific Aims and Hypothesis: In 2007, an expert committee, composed of representatives from 16 major clinical organizations (including the PI of this proposal), published recommendations for primary care office-based treatment of childhood obesity. Seeking both clinical and cost-effectiveness, the recommendations call for staged treatment that starts with low intensity, and then, if unsuccessful, increases to a higher frequency of visits. The committee acknowledged that this staged approach "has not been evaluated." Recent reviews conclude that treatment of childhood obesity can be efficacious. However, most studies were conducted in highly controlled tertiary care research settings and involved a large number of direct contact hours (e.g. many with ≥ 35 contact hours). Research evaluating the translation of these encouraging findings into more real-world clinical settings has been lacking. Specifically, there is little research assessing (1) the feasibility of recruitment from primary care clinics or (2) whether low intensity treatment (i.e. the initial phase of the staged approach recommended by the expert committee) has any benefit on weight loss.
- Aim #1: To assess the feasibility of recruiting overweight and obese children, ages 4-8 years, from a large, urban pediatric primary care clinic, randomizing them to either low-intensity treatment or a control group, and then re-measuring them at approximately 3-months from the date of recruitment.
- Our hypothesis is that we will be able to recruit approximately 70 parent/child dyads and re-measure 80% at 3-months.
- Aim #2: To evaluate whether the proportion of children who decrease their BMI z-score over a 3-month period is higher in those randomly assigned to the intervention group compared with those in the control group.
- Our hypothesis is that the intervention will result in a larger proportion of children decreasing BMI z-score over a 3-month period.
Results from Aims 1 and 2 will be used to plan for an NIH proposal. If the low intensity treatment of this proposal shows a trend toward improvement over usual care, this will justify a full scale, R01 trial testing the complete recommendations of the expert committee. If few subjects in the intervention group have decreasing BMI z-scores, then a smaller NIH trial would be needed to test an amended low-intensity treatment stage with more parent/child contact (e.g. emails, home visits, phone calls).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| behavioral counseling | Experimental | Behavioral: Behavioral counselingReceive counseling via motivational interviewing seeking to encourage health eating habits and increased physical activity |
| Instructions in school readiness and performance | Placebo comparator | Behavioral: Behavioral counselingParents receive instructions in school readiness and performance |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- any patient at the participating clinic between the ages of 4-8 years who have a BMI ≥ the 85th percentile
Key exclusion criteria (3 listed)
- emergent health concern
- serious chronic health concern or recent gastrointestinal illness which may have resulted in weight loss
- on medications known to affect weight
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 |
|---|---|---|
| Behavioral counselingAlso: Motivational Interviewing, Pediatric obesity treatmentCounseling of parents to improve their child's diet and physical activity | Behavioural | Instructions in school readiness and performance, behavioral counseling |
Primary outcome
Body Mass Index Z-score Change
Time frame: Three months
Change in body mass index z-score change over the three month time period
1 secondary outcome
Sugar Sweetened Beverages
Time frame: Three months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Steven D Stovitz, MD, MS principal investigator
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral counseling in people with Obesity, run by University of Minnesota 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 1 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 9 Mar 2017. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 6 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Body Mass Index Z-score Change (time frame: Three 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 9 Mar 2017.