Back to resultsGuided Self-help for Families With an Overweight Child (GSH)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immediate Treatment Group
Delayed Treatment Group
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring obesity, guided self help treatment, treatment method, overweight, overweight children and parents, families with overweight child, efficacy, body mass index, weight
Eligibility Criteria
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)
Sites / Locations
- UCSD Center for Obesity and Health//Pediatrics Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Immediate treatment group
Delayed Treatment Group
Arm Description
The immediate treatment group begins the 5-month treatment immediately after baseline assessment.
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.
Outcomes
Primary Outcome Measures
Child BMI
Secondary Outcome Measures
Parent BMI
Full Information
NCT ID
NCT01145833
First Posted
June 14, 2010
Last Updated
August 18, 2020
Sponsor
University of California, San Diego
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT01145833
Brief Title
Guided Self-help for Families With an Overweight Child
Acronym
GSH
Official Title
Guided Self-help Treatment for Families With an Overweight Child
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, guided self help treatment, treatment method, overweight, overweight children and parents, families with overweight child, efficacy, body mass index, weight
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate treatment group
Arm Type
Active Comparator
Arm Description
The immediate treatment group begins the 5-month treatment immediately after baseline assessment.
Arm Title
Delayed Treatment Group
Arm Type
Other
Arm Description
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 Type
Other
Intervention Name(s)
Immediate Treatment Group
Intervention Description
The immediate treatment group starts the 5-month treatment right after baseline assessment.
Intervention Type
Other
Intervention Name(s)
Delayed Treatment Group
Other Intervention Name(s)
Delayed Treatment Group (Control)
Intervention Description
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 Outcome Measure Information:
Title
Child BMI
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Parent BMI
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerri Boutelle, PhD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Center for Obesity and Health//Pediatrics Department
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
7287977
Citation
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.
Results Reference
result
PubMed Identifier
10619533
Citation
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.
Results Reference
result
PubMed Identifier
12224662
Citation
Epstein LH, Myers MD, Raynor HA, Saelens BE. Treatment of pediatric obesity. Pediatrics. 1998 Mar;101(3 Pt 2):554-70.
Results Reference
result
PubMed Identifier
11746298
Citation
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.
Results Reference
result
PubMed Identifier
8646260
Citation
Epstein LH. Family-based behavioural intervention for obese children. Int J Obes Relat Metab Disord. 1996 Feb;20 Suppl 1:S14-21.
Results Reference
result
PubMed Identifier
25181608
Citation
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.
Results Reference
derived
PubMed Identifier
23545372
Citation
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.
Results Reference
derived
Learn more about this trial
Guided Self-help for Families With an Overweight Child
We'll reach out to this number within 24 hrs