ObesityNCT01221220
Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children
A study of Obesity, run by Stanford University at 1 site in United States.
Trial summary
There is a need for effective weight control methods for obese children. Environmental strategies such as reducing the size of dishware and serving utensils, storing food out of view and reducing food consumption while watching television may reduce food intake without requiring conscious, cognitive self-control. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to 15 Oct 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 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Inclusion Criteria:Inclusion criteria: 8-15 year old obese children (BMI \≥ 95th percentile on the 2000 CDC BMI reference) on the date of randomization. Our standard Stanford Pediatric Weight Control Program eligibility criteria will apply: both child and parent/guardian must want to join, both child and at least one parent/guardian must agree to attend sessions, and must agree to not miss more than 2 consecutive sessions. As we interested in testing generalizable strategies for weight control in diverse populations, the eligibility criteria are designed to be liberal, to maximize the generalizability of the results, but also maintain the internal validity of the test of the intervention. Exclusion Criteria:Exclusions: To enhance internal validity, children will not be eligible if they:
- have been diagnosed with a medical condition affecting growth (a genetic or metabolic disease/syndrome associated obesity, Type 1 diabetes, Type 2 diabetes taking medication, chronic gastrointestinal diseases, Chronic renal diseases, uncorrected structural heart disease, heart failure, heart transplant, anorexia nervosa or bulimia nervosa or binge eating disorder [present or past], AIDS or HIV infection, pregnancy);
- are taking medications affecting growth (systemic corticosteroids more than 2 weeks in the past year, insulin, oral hypoglycemics, thyroid hormone, growth hormone);
- have a condition limiting their participation in the interventions (e.g., unable to participate in routine physical education classes at school, requiring oxygen supplementation for exertion, developmental or physical disability preventing participation in interventions, children or parents/guardians who cannot medically participate in mild dietary restrictions and/or increased physical activity for any reason);
- have a condition limiting participation in the assessments (child or primary caregiver not able to read surveys in English or Spanish, child two or more grade levels delayed in school for reading and writing in his/her native language);
- are unable to read, understand or complete informed consent in English or Spanish;
- plan to move from the San Francisco Bay Area within the next 18 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
There is a need for effective weight control methods for obese children. Environmental strategies such as reducing the size of dishware and serving utensils, storing food out of view and reducing food consumption while watching television may reduce food intake without requiring conscious, cognitive self-control. The investigators propose to test these methods when added to a current state-of-the-art behavioral program.
Read the detailed description
Single blind study with outcome assessors (data collectors)and investigators masked (blinded) to intervention assignment. Analysis is intention-to-treat.
- Conditions
- Obesity
- Being tested
- Standard Packard Pediatric Weight Control Program, Standard Packard Pediatric Weight Control Program plus Home-based advising on environmental changes
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Packard Pediatric Weight Control ProgramBehavioural
Six-month, family-based, group, behavioral weight control program
Standard Packard Pediatric Weight Control Program plus Home-based advising on environmental changesBehavioural
Six-month, family-based, group, behavioral weight control program plus Home-based Environmental strategies intervention
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Treatment | Active comparator | Six-month, family-based, group, behavioral weight control program Receives: Behavioral: Standard Packard Pediatric Weight Control Program |
| Behavioral Treatment plus Environmental Strategies | Experimental | Six-month, family-based, group, behavioral weight control program plus home-based environmental intervention Receives: Behavioral: Standard Packard Pediatric Weight Control Program plus Home-based advising on environmental changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
Measured: 18 months post randomization
Secondary outcomes (11)
Waist Circumference
Measured: 6 months and 18 months post randomization
Triceps skinfold
Measured: 6 months and 18 months post randomization
Resting heart rate
Measured: 6 months and 18 months post randomization
Dietary intake/ meals eaten with television
Measured: 6 months and 18 months post randomization
Weight concerns
Measured: 6 months and 18 months post randomization
Depressive symptoms
Measured: 6 months and 18 months post randomization
Daily energy intake
Measured: 6 months and 18 months post randomization
Physical Activity
Measured: 6 months and 18 months post randomization
Systolic and diastolic blood pressure
Measured: 6 months and 18 months post randomization
Fasting blood lipids, insulin/glucose metabolism
Measured: 6 months and 18 months post randomization
Body Mass Index (BMI)
Measured: 6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startSep 2010
- Primary completion15 Oct 2014
- Study completion15 Oct 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.
- More trials run by Stanford UniversityThe 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
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Thomas Robinson, Stanford University
- Investigators
- Thomas Robinson, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221220
- Sponsor's protocol ID
- SU-08302010-6809
- Other IDs
- R01HL096015
- Status last verified
- May 2021
- First submitted
- 13 Oct 2010
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children
- ClinicalTrials.gov ID
- NCT01221220
- Acronym / sponsor ID
- SU-08302010-6809
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2010
- Primary completion
- 15 Oct 2014 (actual)
- Study completion
- 15 Oct 2014 (actual)
- First posted
- 14 Oct 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.
There is a need for effective weight control methods for obese children. Environmental strategies such as reducing the size of dishware and serving utensils, storing food out of view and reducing food consumption while watching television may reduce food intake without requiring conscious, cognitive self-control. The investigators propose to test these methods when added to a current state-of-the-art behavioral program.
Detailed description
Single blind study with outcome assessors (data collectors)and investigators masked (blinded) to intervention assignment. Analysis is intention-to-treat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Treatment | Active comparator | Behavioral: Standard Packard Pediatric Weight Control ProgramSix-month, family-based, group, behavioral weight control program |
| Behavioral Treatment plus Environmental Strategies | Experimental | Behavioral: Standard Packard Pediatric Weight Control Program plus Home-based advising on environmental changesSix-month, family-based, group, behavioral weight control program plus home-based environmental intervention |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| Standard Packard Pediatric Weight Control ProgramSix-month, family-based, group, behavioral weight control program | Behavioural | Behavioral Treatment |
| Standard Packard Pediatric Weight Control Program plus Home-based advising on environmental changesSix-month, family-based, group, behavioral weight control program plus Home-based Environmental strategies intervention | Behavioural | Behavioral Treatment plus Environmental Strategies |
Primary outcome
Body Mass Index (BMI)
Time frame: 18 months post randomization
11 secondary outcomes
Waist Circumference
Time frame: 6 months and 18 months post randomization
Triceps skinfold
Time frame: 6 months and 18 months post randomization
Resting heart rate
Time frame: 6 months and 18 months post randomization
Dietary intake/ meals eaten with television
Time frame: 6 months and 18 months post randomization
Weight concerns
Time frame: 6 months and 18 months post randomization
Depressive symptoms
Time frame: 6 months and 18 months post randomization
Daily energy intake
Time frame: 6 months and 18 months post randomization
Physical Activity
Time frame: 6 months and 18 months post randomization
Systolic and diastolic blood pressure
Time frame: 6 months and 18 months post randomization
Fasting blood lipids, insulin/glucose metabolism
Time frame: 6 months and 18 months post randomization
Body Mass Index (BMI)
Time frame: 6 months post randomization
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 7 May 2021.
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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.
Thomas Robinson principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Obesity, run by Stanford University 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?
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 7 May 2021. 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?
Body Mass Index (BMI) (time frame: 18 months post randomization). 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 7 May 2021.