ObesityNCT00121706
Fast Food Feeding in Youth
A study testing Condition A (see detailed summary), Condition B (see detailed summary) and Condition C (see detailed summary) in people with Obesity, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The primary aim of the proposed pilot study is to assess the effects of fast food meals, varying in serving size and rate of delivery, on energy (calorie) intake in adolescents. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Condition A (see detailed summary), Condition B (see detailed summary) and Condition C (see detailed summary)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Sep 2005
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Body mass index (BMI) between the 85th and 98th percentiles for sex and age
- Consumption of fast food at least one time per week
- Willingness to eat the foods specified in the research methods
- Parent/guardian willing and able to cooperate
- Access to a working telephone
Who cannot join
- Major medical illness (eg, diabetes; heart, renal, or liver disease; cancer; endocrinopathy)
- Taking any prescription medication that may affect food intake
- Current smoking (i.e., any tobacco in the last month)
- Previous diagnosis of an eating disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
The primary aim of the proposed pilot study is to assess the effects of fast food meals, varying in serving size and rate of delivery, on energy (calorie) intake in adolescents.
Read the detailed description
Using a three-period crossover design, the investigators will evaluate three acute feeding conditions.
- Under Condition A, the total amount of food in a large fast food meal will be delivered on a single tray at Time 0 (start of meal).
- Under Condition B, the same fast food meal will be equally divided among 4 separate portions, with all portions delivered at Time 0.
- Under Condition C, the meal again will be equally divided among 4 separate portions, but the portions will be delivered at 15-minute time intervals (Time 0, 15 minutes, 30 minutes, 45 minutes).
- Conditions
- Obesity
- Being tested
- Condition A (see detailed summary), Condition B (see detailed summary), Condition C (see detailed summary)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Condition A (see detailed summary)Behavioural
Condition B (see detailed summary)Behavioural
Condition C (see detailed summary)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy (calorie) intake during fast food feedings, assessed by direct observation
Secondary outcomes (1)
Energy (calorie) intake during the day of the visit and the day after the visit, assessed by multiple-pass dietary recall interview methodology
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startJul 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 18 participants
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH)
- Investigators
- Cara B Ebbeling, PhD, Principal investigator, Boston Children's HospitalDavid S Ludwig, MD, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121706
- Sponsor's protocol ID
- P30DK040561
- Status last verified
- Jan 2006
- First submitted
- 15 Jul 2005
- Last updated
- 6 Feb 2006
- Results posted
- No
Publications
Ebbeling CB, Sinclair KB, Pereira MA, Garcia-Lago E, Feldman HA, Ludwig DS. Compensation for energy intake from fast food among overweight and lean adolescents. JAMA. 2004 Jun 16;291(23):2828-33. doi: 10.1001/jama.291.23.2828.
PubMed 15199032
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Food Feeding in Youth
- ClinicalTrials.gov ID
- NCT00121706
- Acronym / sponsor ID
- P30DK040561
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH)
- Study start
- Jul 2005
- Study completion
- Sep 2005
- First posted
- 21 Jul 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.
The primary aim of the proposed pilot study is to assess the effects of fast food meals, varying in serving size and rate of delivery, on energy (calorie) intake in adolescents.
Detailed description
Using a three-period crossover design, the investigators will evaluate three acute feeding conditions.
- Under Condition A, the total amount of food in a large fast food meal will be delivered on a single tray at Time 0 (start of meal).
- Under Condition B, the same fast food meal will be equally divided among 4 separate portions, with all portions delivered at Time 0.
- Under Condition C, the meal again will be equally divided among 4 separate portions, but the portions will be delivered at 15-minute time intervals (Time 0, 15 minutes, 30 minutes, 45 minutes).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Body mass index (BMI) between the 85th and 98th percentiles for sex and age
- Consumption of fast food at least one time per week
- Willingness to eat the foods specified in the research methods
- Parent/guardian willing and able to cooperate
- Access to a working telephone
Key exclusion criteria (4 listed)
- Major medical illness (eg, diabetes; heart, renal, or liver disease; cancer; endocrinopathy)
- Taking any prescription medication that may affect food intake
- Current smoking (i.e., any tobacco in the last month)
- Previous diagnosis of an eating disorder
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 |
|---|---|---|
| Condition A (see detailed summary) | Behavioural | – |
| Condition B (see detailed summary) | Behavioural | – |
| Condition C (see detailed summary) | Behavioural | – |
Primary outcome
Energy (calorie) intake during fast food feedings, assessed by direct observation
1 secondary outcome
Energy (calorie) intake during the day of the visit and the day after the visit, assessed by multiple-pass dietary recall interview methodology
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 6 Feb 2006.
- Background: PubMed 15199032Ebbeling CB, Sinclair KB, Pereira MA, Garcia-Lago E, Feldman HA, Ludwig DS. Compensation for energy intake from fast food among overweight and lean adolescents. JAMA. 2004 Jun 16;291(23):2828-33. doi: 10.1001/jama.291.23.2828.
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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.
Cara B Ebbeling, PhD principal investigator
Boston Children's Hospital
David S Ludwig, MD, PhD principal investigator
Boston Children's 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 Condition A (see detailed summary), Condition B (see detailed summary) and Condition C (see detailed summary) in people with Obesity, run by Boston Children's 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 5 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 6 Feb 2006. 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?
Energy (calorie) intake during fast food feedings, assessed by direct observation. 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 NCT00121706, which also lists 1 linked publication.
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 6 Feb 2006.