Guided Self-help for Families With an Overweight Child

Obesity Clinical Trial

— GSH  

Official title:

Guided Self-help Treatment for Families With an Overweight Child

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145833
• Other study ID #: 081129
• Secondary ID: 1R21DK080266-01A
• Status: Completed
• Phase: N/A
• Start date: October 2009
• Est. completion date: October 2011

Study information

• Verified date: August 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Other:
• Immediate Treatment Group
The immediate treatment group starts the 5-month treatment right after baseline assessment.
• 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.

Locations

Country	Name	City	State
United States	UCSD Center for Obesity and Health//Pediatrics Department	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

Epstein LH, Myers MD, Raynor HA, Saelens BE. Treatment of pediatric obesity. Pediatrics. 1998 Mar;101(3 Pt 2):554-70. Review. — View 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. — View Citation

Epstein LH. Family-based behavioural intervention for obese children. Int J Obes Relat Metab Disord. 1996 Feb;20 Suppl 1:S14-21. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child BMI		5 months
Secondary	Parent BMI		5 months