ObesityNCT01358448
A Pilot Study of the Efficacy and Program Cost-effectiveness of Prevention Plus for Childhood Obesity
A study testing growth monitoring and Growth Monitoring plus Family-based Behavioral Counseling in people with Obesity, run by The University of Tennessee, Knoxville at 2 sites in United States.
Trial summary
In 2007 the Expert Committee published recommendations on the prevention and treatment of childhood obesity. These recommendations outlined four interventions intended for advancement based on the child's age, body mass index (BMI), and response to treatment. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Obesity
- What is being tested?
- growth monitoring and Growth Monitoring plus Family-based Behavioral Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2011to Jul 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- between 4 to 8 years of age at the start of the intervention
- overweight or obese (≥85th BMI-for-age percentile)
- have no medical conditions that effect growth, intake or physical activity (e.g., Prader Willi Syndrome, type 2 diabetes, etc.)
- not currently participating in a weight loss program and/or taking weight loss medication
- have a primary caretaker willing to participate in the research study, receive monthly newsletters and be randomized to one of the three conditions
- caretaker must be able to read, speak and understand English and the child speak English
- have transportation to their child's primary care provider office
- family does not plan to move out of the area before March 2012
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Knoxville Pediatric Associates
Knoxville, Tennessee, 37923
Healthy Eating and Activity Laboratory
Knoxville, Tennessee, 37996
About this study
In 2007 the Expert Committee published recommendations on the prevention and treatment of childhood obesity. These recommendations outlined four interventions intended for advancement based on the child's age, body mass index (BMI), and response to treatment. The initial stage, Prevention Plus, is to be implemented in the primary care setting and focuses on primary care providers monitoring growth monthly and delivering intervention messages that target dietary and leisure-time behaviors that most contribute to energy imbalance in children. Little research has evaluated the efficacy of these recommendations. Thus the primary goal of the proposed pilot study is to test the feasibility of the Prevention Plus stage for treating childhood overweight and obesity in a primary care setting. As the cost of interventions is a large barrier to the translation of evidence-based research into primary care settings, a second goal of the project is to evaluate program cost-effectiveness.
- Conditions
- Obesity
- Being tested
- growth monitoring, Growth Monitoring plus Family-based Behavioral Counseling
- Keywords
- Treatment of childhood obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
growth monitoringBehavioural
Caretakers will be encouraged to monitor child growth monthly.
Growth Monitoring plus Family-based Behavioral CounselingBehavioural
Caretakers will monitor growth monthly in addition participating in family-based behavioral counseling
| Study group | Role | What they receive |
|---|---|---|
| Newsletter | No intervention | Not described |
| Growth Monitoring | Experimental | Not described Receives: Behavioral: growth monitoring |
| Growth Monitoring plus Family-based Behavioral Counseling | Experimental | Not described Receives: Behavioral: Growth Monitoring plus Family-based Behavioral Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Status
BMI z-score
Measured: Baseline and 6-month
Dietary Intake
dietary intake (sweetened beverages, fruits and vegetables, energy, and percent energy from fat)
Measured: baseline and 6-months
Leisure-time Behaviors
leisure-time behaviors (moderate-intense physical activity and television viewing)
Measured: Baseline and 6-months
Caretaker Feeding Behaviors
Caretaker feeding behaviors (authoritative, authoritarian, permissive, restrictive) assessed by questionnaires
Measured: Baseline and 6-months
Secondary outcomes (1)
Cost Effectiveness
The total program cost per 0.1 change in BMI z-score
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 posted23 May 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2014
- Study completionJul 2014
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hollie Raynor, The University of Tennessee, Knoxville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358448
- Sponsor's protocol ID
- UT8433B
- Status last verified
- Apr 2018
- First submitted
- 17 May 2011
- Last updated
- 5 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Efficacy and Program Cost-effectiveness of Prevention Plus for Childhood Obesity
- ClinicalTrials.gov ID
- NCT01358448
- Acronym / sponsor ID
- UT8433B
- Conditions
- Obesity
- Keywords
- Treatment of childhood obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 23 May 2011 (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.
In 2007 the Expert Committee published recommendations on the prevention and treatment of childhood obesity. These recommendations outlined four interventions intended for advancement based on the child's age, body mass index (BMI), and response to treatment. The initial stage, Prevention Plus, is to be implemented in the primary care setting and focuses on primary care providers monitoring growth monthly and delivering intervention messages that target dietary and leisure-time behaviors that most contribute to energy imbalance in children. Little research has evaluated the efficacy of these recommendations. Thus the primary goal of the proposed pilot study is to test the feasibility of the Prevention Plus stage for treating childhood overweight and obesity in a primary care setting. As the cost of interventions is a large barrier to the translation of evidence-based research into primary care settings, a second goal of the project is to evaluate program cost-effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Newsletter | No intervention | – |
| Growth Monitoring | Experimental | Behavioral: growth monitoring |
| Growth Monitoring plus Family-based Behavioral Counseling | Experimental | Behavioral: Growth Monitoring plus Family-based Behavioral Counseling |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- between 4 to 8 years of age at the start of the intervention
- overweight or obese (≥85th BMI-for-age percentile)
- have no medical conditions that effect growth, intake or physical activity (e.g., Prader Willi Syndrome, type 2 diabetes, etc.)
- not currently participating in a weight loss program and/or taking weight loss medication
- have a primary caretaker willing to participate in the research study, receive monthly newsletters and be randomized to one of the three conditions
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 |
|---|---|---|
| growth monitoringCaretakers will be encouraged to monitor child growth monthly. | Behavioural | Growth Monitoring |
| Growth Monitoring plus Family-based Behavioral CounselingCaretakers will monitor growth monthly in addition participating in family-based behavioral counseling | Behavioural | Growth Monitoring plus Family-based Behavioral Counseling |
Primary outcome
Weight Status
Time frame: Baseline and 6-month
BMI z-score
Dietary Intake
Time frame: baseline and 6-months
dietary intake (sweetened beverages, fruits and vegetables, energy, and percent energy from fat)
Leisure-time Behaviors
Time frame: Baseline and 6-months
leisure-time behaviors (moderate-intense physical activity and television viewing)
Caretaker Feeding Behaviors
Time frame: Baseline and 6-months
Caretaker feeding behaviors (authoritative, authoritarian, permissive, restrictive) assessed by questionnaires
1 secondary outcome
Cost Effectiveness
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 5 Apr 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing growth monitoring and Growth Monitoring plus Family-based Behavioral Counseling in people with Obesity, run by The University of Tennessee, Knoxville 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 8 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 5 Apr 2018. 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?
Weight Status (time frame: Baseline and 6-month). 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 5 Apr 2018.