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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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:

  1. 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);
  2. are taking medications affecting growth (systemic corticosteroids more than 2 weeks in the past year, insulin, oral hypoglycemics, thyroid hormone, growth hormone);
  3. 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);
  4. 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);
  5. are unable to read, understand or complete informed consent in English or Spanish;
  6. 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

Other trials in United States

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 groups in NCT01221220
Study groupRoleWhat they receive
Behavioral TreatmentActive comparatorSix-month, family-based, group, behavioral weight control program
Receives: Behavioral: Standard Packard Pediatric Weight Control Program
Behavioral Treatment plus Environmental StrategiesExperimentalSix-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.

  1. Body Mass Index (BMI)

    Measured: 18 months post randomization

Secondary outcomes (11)
  1. Waist Circumference

    Measured: 6 months and 18 months post randomization

  2. Triceps skinfold

    Measured: 6 months and 18 months post randomization

  3. Resting heart rate

    Measured: 6 months and 18 months post randomization

  4. Dietary intake/ meals eaten with television

    Measured: 6 months and 18 months post randomization

  5. Weight concerns

    Measured: 6 months and 18 months post randomization

  6. Depressive symptoms

    Measured: 6 months and 18 months post randomization

  7. Daily energy intake

    Measured: 6 months and 18 months post randomization

  8. Physical Activity

    Measured: 6 months and 18 months post randomization

  9. Systolic and diastolic blood pressure

    Measured: 6 months and 18 months post randomization

  10. Fasting blood lipids, insulin/glucose metabolism

    Measured: 6 months and 18 months post randomization

  11. 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.

  1. First posted14 Oct 2010 (estimated)
  2. Study startSep 2010
  3. Primary completion15 Oct 2014
  4. Study completion15 Oct 2014

Resources

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)
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

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.

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