Clinical trial NCT01145833: Guided Self-help for Families With an Overweight Child
Official title: Guided Self-help Treatment for Families With an Overweight Child
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
guided self help treatment
treatment method
overweight
overweight children and parents
families with overweight child
efficacy
body mass index
weight
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-06-17
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Child BMI
timeFrame: 5 months
Secondary outcomes:
measure: Parent BMI
timeFrame: 5 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Center for Obesity and Health//Pediatrics Department
state: California
Study officials:
affiliation: UCSD
name: Kerri Boutelle, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Epstein LH, Myers MD, Raynor HA, Saelens BE. Treatment of pediatric obesity. Pediatrics. 1998 Mar;101(3 Pt 2):554-70.
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.
citation: Epstein LH. Family-based behavioural intervention for obese children. Int J Obes Relat Metab Disord. 1996 Feb;20 Suppl 1:S14-21.
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.
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.