Guided Self-help for Families With an Overweight Child (GSH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of California, San Diego.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01145833
First received: June 14, 2010
Last updated: June 16, 2010
Last verified: June 2010

June 14, 2010
June 16, 2010
October 2009
September 2011   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
The primary hypothesis is that children will show a decrease in weight (BMI for age percentile/percentage overweight) immediately following guided self-help treatment and at 6 month follow-up as compared to the delayed treatment control.
Same as current
Complete list of historical versions of study NCT01145833 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    The secondary hypothesis is that children and parents will report increases in physical activity that will support weight loss as compared to the delayed treatment control.
  • 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 ] [ Designated as safety issue: No ]
    The secondary hypothesis is that children and parents will report increases in fruit and vegetable intake that will support weight loss as compared to the delayed treatment control.
  • 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 ] [ Designated as safety issue: No ]
    The secondary hypothesis is that children and parents will report changes in home food availability that will support weight loss as compared to the delayed treatment control.
  • 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 ] [ Designated as safety issue: No ]
    We predict that overweight parents will also show a decrease in weight (BMI) while non-overweight parents will maintain their weight.
  • 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 ] [ Designated as safety issue: No ]
    The secondary hypothesis is that children and parents will report decreases in sedentary activity.
Same as current
Not Provided
Not Provided
 
Guided Self-help for Families With an Overweight Child
Guided Self-help Treatment 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
  • Other: Immediate Treatment Group
    The immediate treatment group starts the 5-month treatment right after baseline assessment.
    Other Name: Immediate Treatment Group
  • Other: Delayed Treatment Group
    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 Name: Delayed Treatment Group (Control)
  • Active Comparator: Immediate treatment group
    The immediate treatment group begins the 5-month treatment immediately after baseline assessment.
    Intervention: Other: Immediate Treatment Group
  • Delayed Treatment Group
    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.
    Intervention: Other: Delayed Treatment Group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
49
October 2011
September 2011   (final data collection date for primary outcome measure)

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)
Both
8 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01145833
081129, 1R21DK080266-01A1
Yes
Kerri Boutelle, Ph.D, UCSD
University of California, San Diego
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Kerri Boutelle, PhD UCSD
University of California, San Diego
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP