NCT01221220

Brief 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. The investigators propose to test these methods when added to a current state-of-the-art behavioral program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2014

Completed
Last Updated

May 7, 2021

Status Verified

May 1, 2021

Enrollment Period

4.1 years

First QC Date

October 13, 2010

Last Update Submit

May 4, 2021

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index (BMI)

    18 months post randomization

Secondary Outcomes (11)

  • Waist Circumference

    6 months and 18 months post randomization

  • Triceps skinfold

    6 months and 18 months post randomization

  • Resting heart rate

    6 months and 18 months post randomization

  • Dietary intake/ meals eaten with television

    6 months and 18 months post randomization

  • Weight concerns

    6 months and 18 months post randomization

  • +6 more secondary outcomes

Study Arms (2)

Behavioral Treatment

ACTIVE COMPARATOR

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

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

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

Interventions

Standard Packard Pediatric Weight Control ProgramBEHAVIORAL

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

Behavioral Treatment
Standard Packard Pediatric Weight Control Program plus Home-based advising on environmental changesBEHAVIORAL

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

Behavioral Treatment plus Environmental Strategies

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas Robinson

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Irving Schulman, MD Endowed Professor in Child Health; Professor of Pediatrics and of Medicine and CHP/PCOR Associate

Study Record Dates

First Submitted

October 13, 2010

First Posted

October 14, 2010

Study Start

September 1, 2010

Primary Completion

October 15, 2014

Study Completion

October 15, 2014

Last Updated

May 7, 2021

Record last verified: 2021-05

Locations

US(1)