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Completed

NCT Number: NCT01221220

Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children

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.

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Key information

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

Single blind study with outcome assessors (data collectors)and investigators masked (blinded) to intervention assignment. Analysis is intention-to-treat.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard Packard Pediatric Weight Control Program

Behavioral

Six-month, family-based, group, behavioral weight control program

Standard Packard Pediatric Weight Control Program plus Home-based advising on environmental changes

Behavioral

Six-month, family-based, group, behavioral weight control program plus Home-based Environmental strategies intervention

Primary outcomes

  1. Body Mass Index (BMI)

    Time frame: 18 months post randomization

Secondary outcomes

  1. Waist Circumference

    Time frame: 6 months and 18 months post randomization

  2. Triceps skinfold

    Time frame: 6 months and 18 months post randomization

  3. Resting heart rate

    Time frame: 6 months and 18 months post randomization

  4. Dietary intake/ meals eaten with television

    Time frame: 6 months and 18 months post randomization

  5. Weight concerns

    Time frame: 6 months and 18 months post randomization

  6. Depressive symptoms

    Time frame: 6 months and 18 months post randomization

  7. Daily energy intake

    Time frame: 6 months and 18 months post randomization

  8. Physical Activity

    Time frame: 6 months and 18 months post randomization

  9. Systolic and diastolic blood pressure

    Time frame: 6 months and 18 months post randomization

  10. Fasting blood lipids, insulin/glucose metabolism

    Time frame: 6 months and 18 months post randomization

  11. Body Mass Index (BMI)

    Time frame: 6 months post randomization

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 14, 2010
Registry last updated
May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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