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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00024830
Other study ID # 987
Secondary ID R01HL065132
Status Completed
Phase N/A
First received September 28, 2001
Last updated March 15, 2016
Start date September 1999
Est. completion date August 2002

Study information

Verified date October 2005
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

To evaluate the efficacy of peer-based skills training to enhance weight control and improve psychosocial functioning in overweight adolescents.


Description:

BACKGROUND:

The prevalence of obesity in children, adolescents, and adults has increased significantly over the last two decades. Adolescents who are obese are at great risk for remaining obese into adulthood. Given the difficulty of treating adult obesity, intervening with adolescents before they reach adulthood is critical. Decreasing obesity during adolescence provides an opportunity to prevent the continuance of pediatric onset obesity into adulthood. There are well-established weight control interventions for children between 8 and 12 years of age. However, treatment findings with overweight adolescents are not as robust and are difficult to replicate. One potential limitation of existing weight control interventions for adolescents is the minimal attention given to the peer group as an active component of treatment.

The study was in response to an initiative issued by the National Institute of Diabetes and Digestive and Kidney Diseases and entitled "Innovative Approaches to the Prevention of Obesity". The resulting grant was later reassigned to the National Heart, Lung, and Blood Institute.

DESIGN NARRATIVE:

A total of 119 adolescents between the ages of 13 and 16 years and between 20 and 80% overweight were randomized to one of three treatment conditions: (1) cognitive-behavioral treatment (CBT); (2) cognitive-behavioral treatment with the addition of peer-based skills training (CBT + PBST); or 3) standard care (SC). The cognitive-behavioral intervention consisted of 16 weekly sessions followed by four monthly maintenance sessions. Adolescents randomized to CBT + PBST received the cognitive-behavioral treatment as well as an intensive 32 session peer-based intervention. The peer-based intervention combined problem-solving therapy with principles from Outward Bound to address self-reliance, social competence and physical self-worth. One way analyses of variance was conducted at the end of treatment and at 6-months after the end of treatment to compare the three groups on initial reduction in percent overweight and maintenance of decreases in percent overweight at follow-up. Analysis of variance was also used to compare the three groups on measures of social functioning, self-esteem, physical activity level, and physical self-worth.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date August 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years to 16 Years
Eligibility No eligibility criteria

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (1)

Jelalian E, Mehlenbeck R, Lloyd-Richardson EE, Birmaher V, Wing RR. 'Adventure therapy' combined with cognitive-behavioral treatment for overweight adolescents. Int J Obes (Lond). 2006 Jan;30(1):31-9. — View Citation

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