ObesityNCT00200265
Changing Eating Behaviors in Young Children: Should Healthy Foods be Increased or Unhealthy Foods Decreased?
A study testing diet in people with Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
Recommendations for treatment of childhood obesity in a primary care setting have been developed. These recommendations include beginning treatment with young children, focusing treatment on the parent so the parent can assist the child in making changes, and changing 2 or 3 very specific eating or activity behaviors… Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Dec 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 4 and 9 years. We propose to use this age group since parents are in control of the eating and exercise choices of such children, and thus a program that focuses on parenting behaviors (i.e., positive reinforcement, stimulus control, parental modeling) should be developmentally appropriate. This age group also meets the Expert Committee's goal of intervening early5; moreover children aged 4 to 8 years have similar nutritional needs.
- Body mass index (BMI) > 85th percentile BMI. Based upon the Expert Committee recommendations,5 children > 2 years of age who are identified as being at risk for overweight (85th to 94th percentile BMI) or overweight (> 95th percentile BMI) should focus on weight maintenance as height continues to increase. These recommendations are aimed at reducing z-BMI.
- Tanner stage 1 (prepubertal) sexual maturation status.
- Self-report at least one of the following problematic behaviors:
- Consume < 2 servings per day of whole fruit (not juice) or < 3 servings per day of vegetables.
- Consume > 1 serving of sweetened drink per day.
Show all 11Show fewer
- Consume < 2 servings of low-fat milk per day.
- Consume > 4 times per week of sweet or salty snack foods.
- A parent willing to attend treatment meetings.
- Parent and child speak English.
- -
Who cannot join
- Report a family member participating in another weight loss program.
- Report that the child or parent planning to attend the treatment meetings has a major psychiatric disease or organic brain syndrome.
- Report that the child or parent planning to attend the treatment meetings has dietary or physical activity restrictions.
- Intend to move outside of the metropolitan area within the time frame of the investigation.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
The Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
About this study
Recommendations for treatment of childhood obesity in a primary care setting have been developed. These recommendations include beginning treatment with young children, focusing treatment on the parent so the parent can assist the child in making changes, and changing 2 or 3 very specific eating or activity behaviors (i.e., eat less snacks, rather than eat less calories). The effectiveness of these recommendations has never been evaluated. This project's goal is to develop, implement, and evaluate a 6-month childhood obesity intervention meeting these recommendations. Another goal of the project is to compare two different approaches, focusing on either decreasing intake of two unhealthy foods or increasing intake of two healthy foods, for changing eating behaviors during treatment. Two hundred ten children, between the ages of 4 to 9 years, who are at risk for overweight or overweight, based upon weight and height standards, will be randomized to one of three treatments: 1) a Newsletter treatment (provided with information on healthy eating only); 2) a Parent Program that decreases intake of sweet/salty snack foods (< 3 servings/week) and sweetened drinks (< 3 servings/week); or 3) a Parent Program that increases intake of fruits and vegetables (5 servings/day) and low-fat dairy products (2 servings/day). Children's height and weight will be measured at 0, 3, 6, 9, and 12 months. This project will determine if the recommendations for treatment are effective, and if focusing on decreasing intake of unhealthy foods or increasing intake of healthy foods produces a better long-term weight loss outcome.
- Conditions
- Obesity
- Being tested
- diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietBehavioural
diet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Behavioral: diet Receives: Behavioral: diet |
| 2 | Experimental | Behavioral: diet Receives: Behavioral: diet |
| 3 | Placebo comparator | Behavioral: diet Receives: Behavioral: diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
z-BMI in children
Measured: 12 months
Secondary outcomes (1)
Eating and activity behaviors
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Hollie A Raynor, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200265
- Sponsor's protocol ID
- 7-05-HFC-27
- Status last verified
- Dec 2007
- First submitted
- 12 Sep 2005
- Last updated
- 20 Apr 2012
- Results posted
- No
Publications
Hart CN, Raynor HA, Osterholt KM, Jelalian E, Wing RR. Eating and activity habits of overweight children on weekdays and weekends. Int J Pediatr Obes. 2011 Oct;6(5-6):467-72. doi: 10.3109/17477166.2011.590204. Epub 2011 Jul 20.
PubMed 21774578Raynor HA, Osterholt KM, Hart CN, Jelalian E, Vivier P, Wing RR. Evaluation of active and passive recruitment methods used in randomized controlled trials targeting pediatric obesity. Int J Pediatr Obes. 2009;4(4):224-32. doi: 10.3109/17477160802596189.
PubMed 19922036
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Eating Behaviors in Young Children: Should Healthy Foods be Increased or Unhealthy Foods Decreased?
- ClinicalTrials.gov ID
- NCT00200265
- Acronym / sponsor ID
- 7-05-HFC-27
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Jul 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 20 Sep 2005 (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.
Recommendations for treatment of childhood obesity in a primary care setting have been developed. These recommendations include beginning treatment with young children, focusing treatment on the parent so the parent can assist the child in making changes, and changing 2 or 3 very specific eating or activity behaviors (i.e., eat less snacks, rather than eat less calories). The effectiveness of these recommendations has never been evaluated. This project's goal is to develop, implement, and evaluate a 6-month childhood obesity intervention meeting these recommendations. Another goal of the project is to compare two different approaches, focusing on either decreasing intake of two unhealthy foods or increasing intake of two healthy foods, for changing eating behaviors during treatment. Two hundred ten children, between the ages of 4 to 9 years, who are at risk for overweight or overweight, based upon weight and height standards, will be randomized to one of three treatments: 1) a Newsletter treatment (provided with information on healthy eating only); 2) a Parent Program that decreases intake of sweet/salty snack foods (< 3 servings/week) and sweetened drinks (< 3 servings/week); or 3) a Parent Program that increases intake of fruits and vegetables (5 servings/day) and low-fat dairy products (2 servings/day). Children's height and weight will be measured at 0, 3, 6, 9, and 12 months. This project will determine if the recommendations for treatment are effective, and if focusing on decreasing intake of unhealthy foods or increasing intake of healthy foods produces a better long-term weight loss outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: dietBehavioral: diet |
| 2 | Experimental | Behavioral: dietBehavioral: diet |
| 3 | Placebo comparator | Behavioral: dietBehavioral: diet |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Age between 4 and 9 years. We propose to use this age group since parents are in control of the eating and exercise choices of such children, and thus a program that focuses on parenting behaviors (i.e., positive reinforcement, stimulus control, parental modeling) should be developmentally appropriate. This age group also meets the Expert Committee's goal of intervening early5; moreover children aged 4 to 8 years have similar nutritional needs.
- Body mass index (BMI) > 85th percentile BMI. Based upon the Expert Committee recommendations,5 children > 2 years of age who are identified as being at risk for overweight (85th to 94th percentile BMI) or overweight (> 95th percentile BMI) should focus on weight maintenance as height continues to increase. These recommendations are aimed at reducing z-BMI.
- Tanner stage 1 (prepubertal) sexual maturation status.
- Self-report at least one of the following problematic behaviors:
- A parent willing to attend treatment meetings.
Key exclusion criteria (5 listed)
- Report a family member participating in another weight loss program.
- Report that the child or parent planning to attend the treatment meetings has a major psychiatric disease or organic brain syndrome.
- Report that the child or parent planning to attend the treatment meetings has dietary or physical activity restrictions.
- Intend to move outside of the metropolitan area within the time frame of the investigation.
- -
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 |
|---|---|---|
| dietdiet | Behavioural | 1, 2, 3 |
Primary outcome
z-BMI in children
Time frame: 12 months
1 secondary outcome
Eating and activity behaviors
Time frame: 12 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 20 Apr 2012.
- Derived from this study: PubMed 21774578Hart CN, Raynor HA, Osterholt KM, Jelalian E, Wing RR. Eating and activity habits of overweight children on weekdays and weekends. Int J Pediatr Obes. 2011 Oct;6(5-6):467-72. doi: 10.3109/17477166.2011.590204. Epub 2011 Jul 20.
- Derived from this study: PubMed 19922036Raynor HA, Osterholt KM, Hart CN, Jelalian E, Vivier P, Wing RR. Evaluation of active and passive recruitment methods used in randomized controlled trials targeting pediatric obesity. Int J Pediatr Obes. 2009;4(4):224-32. doi: 10.3109/17477160802596189.
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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.
Hollie A Raynor, PhD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diet in people with Obesity, run by The Miriam Hospital 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 11 inclusion and 5 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 20 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. 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?
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?
z-BMI in children (time frame: 12 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 NCT00200265, which also lists 2 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 20 Apr 2012; AzTrials last refreshed its copy on 8 Nov 2026.