Guided Self-help for Families With an Overweight Child (GSH)
August 18, 2020 updated by: Kerri Boutelle, University of California, San Diego
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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La Jolla, California, United States, 92037
- UCSD Center for Obesity and Health//Pediatrics Department
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Immediate treatment group
The immediate treatment group begins the 5-month treatment immediately after baseline assessment.
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The immediate treatment group starts the 5-month treatment right after baseline assessment.
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Other: 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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Child BMI
Time Frame: 5 months
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Parent BMI
Time Frame: 5 months
|
5 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kerri Boutelle, PhD, UCSD
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Epstein LH, Wing RR, Koeske R, Andrasik F, Ossip DJ. Child and parent weight loss in family-based behavior modification programs. J Consult Clin Psychol. 1981 Oct;49(5):674-85. doi: 10.1037//0022-006x.49.5.674. No abstract available.
- Epstein LH, Kilanowski CK, Consalvi AR, Paluch RA. Reinforcing value of physical activity as a determinant of child activity level. Health Psychol. 1999 Nov;18(6):599-603.
- Epstein LH, Myers MD, Raynor HA, Saelens BE. Treatment of pediatric obesity. Pediatrics. 1998 Mar;101(3 Pt 2):554-70.
- Peterson CB, Mitchell JE, Engbloom S, Nugent S, Pederson Mussell M, Crow SJ, Thuras P. Self-help versus therapist-led group cognitive-behavioral treatment of binge eating disorder at follow-up. Int J Eat Disord. 2001 Dec;30(4):363-74. doi: 10.1002/eat.1098.
- Epstein LH. Family-based behavioural intervention for obese children. Int J Obes Relat Metab Disord. 1996 Feb;20 Suppl 1:S14-21.
- Accurso EC, Norman GJ, Crow SJ, Rock CL, Boutelle KN. The role of motivation in family-based guided self-help treatment for pediatric obesity. Child Obes. 2014 Oct;10(5):392-9. doi: 10.1089/chi.2014.0023. Epub 2014 Sep 2.
- Boutelle KN, Norman GJ, Rock CL, Rhee KE, Crow SJ. Guided self-help for the treatment of pediatric obesity. Pediatrics. 2013 May;131(5):e1435-42. doi: 10.1542/peds.2012-2204. Epub 2013 Apr 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
June 14, 2010
First Submitted That Met QC Criteria
June 16, 2010
First Posted (Estimate)
June 17, 2010
Study Record Updates
Last Update Posted (Actual)
September 3, 2020
Last Update Submitted That Met QC Criteria
August 18, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 081129
- 1R21DK080266-01A1 (U.S. NIH Grant/Contract)
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