Overview

This trial is active, not recruiting.

Condition obesity
Treatments immediate treatment group, delayed treatment group
Sponsor University of California, San Diego
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date October 2009
End date September 2011
Trial size 49 participants
Trial identifier NCT01145833, 081129, 1R21DK080266-01A1

Summary

The purpose of this study is to evaluate whether a home based program can teach parents and moderately overweight kids who are of 8-12 years old with a BMI% between 85-97%, how to manage their child's weight. The study uses manuals and involves a short visit to the clinic every other week.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
The immediate treatment group begins the 5-month treatment immediately after baseline assessment.
immediate treatment group Immediate Treatment Group
The immediate treatment group starts the 5-month treatment right after baseline assessment.
(Other)
The delayed treatment group serves as the control group. This group starts treatment 5 months after the baseline assessment. No intervention is involved during this 5-month waiting period. After 5 months, the delayed group is assessed for the second time and then begins the 5-month treatment.
delayed treatment group Delayed Treatment Group (Control)
The delayed treatment group does not start treatment immediately after the baseline assessment. This group serves as the control group, by not receiving any treatment for 5 months. After the 5 months, the delayed group participants are asked to come in for a second assessment that involves completion of surveys and measurement of height, weight, and physical activity level. After this assessment is completed, the delayed group participants can begin the 5-month treatment.

Primary Outcomes

Measure
The extent to which the guided self-help program affects body weight in the target child
time frame: At post-treatment visit (after 5-month treatment) and 6-month follow-up

Secondary Outcomes

Measure
The extent to which the guided self-help program affects physical activity.
time frame: At post-treatment visit (after 5-month treatment) and at 6-month follow-up
The extent to which the guided self-help program affects dietary quality.
time frame: At post-treatment visit (after 5-month treatment) and at 6-month follow-up
The extent to which the guided self-help program affects home food environment.
time frame: At post-treatment visit (after 5-month treatment) and at 6-month follow-up
The extent to which the guided self-help program affects parent body weight.
time frame: At post-treatment visit (after 5-month treatment) and at 6-month follow-up
The extent to which the guided self-help program affects sedentary activity.
time frame: At post-treatment visit (after 5-month treatment) and at 6-month follow-up

Eligibility Criteria

Male or female participants from 8 years up to 12 years old.

Inclusion Criteria: - child between the ages of 8 & 12 - an moderately overweight child with a BMI% between 85-97% - child has a parent willing to participate - child has a parent who can read English at a minimum of a 6th grade level - family who is willing to commit to treatment attendance and attendance at all assessments. Exclusion Criteria: - Child psychiatric disorder diagnoses (based on parent report) - Child diagnoses of a serious current physical disease (such as diabetes) - Child who is taking medications that may impact their weight - Child with physical difficulties that limit the ability to exercise - Child with an active eating disorder - Child and parent will be moving out of the San Diego County before study completion - Child and/or parent has a modified diet due to religious or socially conscious reasons (such as Vegan, vegetarian)

Additional Information

Official title Guided Self-help Treatment for Families With an Overweight Child
Principal investigator Kerri Boutelle, PhD
Description An estimated 4-5 million children between the ages of 6-17 in the United States are obese. Children who are obese are at an increased risk for many negative health consequences in childhood and in adulthood. In addition, these children are at an increased risk for psychosocial consequences in childhood and adolescence, including poor self-esteem, teasing, verbal abuse and social isolation. Guided self-help offers an opportunity to provide empirically based programs to a larger amount of the target population. Once such treatment methods are available, it is possible that the guided self-help treatment for childhood obesity can be disseminated to primary care practitioners, psychologists, nurses, and health educators. Ultimately, the goal of this application is to develop a treatment protocol that can be used by clinics and lay health professionals to intervene with children who are overweight and their parents.
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by University of California, San Diego.