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Completed

NCT Number: NCT01145833

Guided Self-help for Families With an Overweight Child

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.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSD Center for Obesity and Health//Pediatrics Department

La Jolla, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Immediate Treatment Group

Other

The immediate treatment group starts the 5-month treatment right after baseline assessment.

Delayed Treatment Group

Other

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.

Other names: Delayed Treatment Group (Control)

Primary outcomes

  1. Child BMI

    Time frame: 5 months

Secondary outcomes

  1. Parent BMI

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Guided Self-help Treatment for Families With an Overweight Child

Acronym: GSH

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 17, 2010
Registry last updated
Sep 3, 2020

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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