Low-level Intervention for Adolescents With Extreme Obesity

Not Applicable

Completed

• Conditions: Obesity; Extreme Obesity
• Interventions: Behavioral: manual based low key group intervention (innovation); Behavioral: standardized, manual based routine care

• Registration Number: NCT01703273
• Lead Sponsor: Prof. Dr. Martin Wabitsch

Brief Summary

While adolescents with obesity and extreme obesity are at increased risk for health complications, especially adolescents with extreme obesity rarely seek medical care, and sustained weigh loss is hardly ever achieved. One of the underlying reasons might be the lack of adequate treatment options.

In this multicenter study, we aim to test a new, low key group intervention focusing on improving compliance and psychosocial functioning. The study is a subproject of the Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care, short: "Youth with Extreme obesity Study (YES)", which aims at improving the medical care and social support structures for youth with obesity and extreme obesity in Germany.

Obese youth and young adults (BMI ≥ 30kg/m2) between the ages of 14 and 24.9 years (initially up to 21 years) are eligible to participate. Participants will be asked to complete a series of questionnaires on their general health, psychosocial situation and wellbeing, and will be offered a thorough medical evaluation. Individuals who complete the baseline evaluations will be invited to participate in 6 group sessions over a 3 months period. Group assignment to the psycho-social intervention vs. routine care group will be at random, like throwing a dice. After 6 months, participants will complete further questionnaires to evaluate the effects of the interventions on quality of life and psycho-social functionning.

The study will show the acceptance and effectiveness of a new intervention focusing on improving compliance and psychosocial functioning in adolescents with extreme obesity, and thereby inform the development of new treatment and support options for these adolescents. If interested, participants are invited to participate in additional components of YES, and to receive medical care and psycho-social support.

Detailed Description

While obese youth are at high risk for co-morbidities, especially the extremely obese individuals rarely seek medical care. The underlying reasons are poorly understood, but patient inherent factors and the lack of adequate treatment options may play a role.

In this multicenter study, we aim to assess the acceptance and effectiveness of a manual based low key group intervention focusing on improving compliance and psychosocial functioning in adolescents with morbid obesity (BMI≥35kg/m2), in comparison to routine care. Youth with more moderate degrees of obesity (BMI 30-34.9kg/m2) will serve as an additional control group. The study is part of the Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care", short: "Youth with extreme obesity Study (YES), which also comprises the recruitment and characterization of obese (BMI 30-34.9kg/m2) and extremely obese (BMI ≥ 35kg/m2) youth from different healthcare- and non healthcare settings, a structured prospective evaluation of adolescent bariatric surgery, economic assessments of the financial burden of extreme adolescent obesity on the healthcare system, and a long-term prospective observation study.

Based on the current state of knowledge, we will test the a priori ordered hirarchy of hypotheses:

1. The compliance rate 6 months after randomization is higher in subjects in the low key intervention group compared to the standard care group.

2. Covariant-adjusted changes in quality of life (assessed by DISABKIDS scale) between baseline and the 6 months follow up will be more pronounced in the low key intervention group compared to the standard care group.

The five participating university centers are distributed across 4 geographic regions in the North (Berlin), in the West (Essen/Datteln), in the East (Leipzig) and in the South (Ulm) of Germany, and will therefore render data that are representative of Germany as a whole. We will screen a 600 adolescents age 14 to 24.9 years (initially up to 21 years; this was changed in an amendment in February 2013) with extreme obesity (BMI ≥ 35 kg/m2) and 600 adolescents with obesity (BMI 30-34.9 kg/m2) over a 24 months period. A total of 350 subjects will be enrolled. Baseline assessments include an array of standardized questionnaires and validated instruments to assess health, psycho-social situation, psychiatric co-morbidities and health related quality of life, as well as an in-depth medical evaluation. Individuals who complete the baseline evaluations will be invited to participate in 6 group sessions over a 3 months period. Group assignment to the low key intervention vs. standard care group will be at random. The effects of the interventions on health related quality of life and psycho-social functioning will be assessed via questionnaires after 6 months. Subsequently, subjects will be invited to participate in additional components of YES.

The project will reveal the effectiveness and safety of a manual based low key group intervention focusing on improving compliance and psychosocial functioning in adolescents with morbid obesity, and thereby inform the development of new treatment and support options for these adolescents in Germany.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-07
• Study First Submitted QC: 2012-10-09
• Study First Posted: 2012-10-10
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-12
• Last Update Posted: 2018-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

• BMI ≥30kg/m2
• sufficient German language skills

Exclusion Criteria

• Circumstances that require immediate inpatient care (e.g. severe somatic or psychiatric illness)
• obvious cognitive disability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low key intervention	manual based low key group intervention (innovation)	-
routine care	standardized, manual based routine care	-

Primary Outcome Measures

Name	Time	Method
Composite primary endpoint (tested hierarchically) of a) compliance rate and b) changes in health related quality of life.	baseline and 6 months	a) Number of regular participants at 6 months follow up will be divided by number of participants at baseline. b) Changes (randomization - 6 months follow up) in the 37 item DISABKIDS questionnaire will be assessed.

Secondary Outcome Measures

Name	Time	Method
Changes in self-esteem	baseline and 6 months	The Rosenberg's scale patient questionnaire will be applied twice, and the score difference will be calculated for each subject.
Changes in the self reported attendance of school, apprenticeship, or work	baseline and 6 months	The attendance of school, apprenticeship, or work will be elicited twice via standardized patient questionnaire (modified after KIGGS and TeenLABS), and the time difference will be calculated for each subject.
Changes in the 6 subscales of DISABKIDS	baseline and 6 months	The 37 item DISABKIDS questionnaire will be applied twice, and the score difference in each of the 6 subscales will be calculated for each subject.
Changes in perceived stress	baseline and 6 months	The Fliege scale questionnaire will be applied twice, and the score difference will be calculated for each subject.
Changes in self reported physician- / and therapist contacts	baseline and 6 months	Physician- / and therapist contacts will be elicited twice via standardized patient questionnaire (modified after KIGGS and TeenLABS), and the difference will be calculated for each subject.
Changes in quality of life	baseline and 6 months	The 52 item KIDSCREEN-52 questionnaire will be applied twice, and the score difference will be calculated for each subject.
Changes in self reported time spent outside the home	baseline and 6 months	The time spent outside the home will be elicited twice via standardized patient questionnaire (modified after KIGGS and TeenLABS), and the time difference will be calculated for each subject.
Changes in depression symptoms	baseline and 6 months	The Becks Depression Inventory 2 questionnaire will be applied twice, and the score difference will be calculated for each subject. Answers will be reviewed immediately to identify and treat subjects at risk for self harm.

Trial Locations

Locations (6)

Vestische Kinderklinik, University of Witten/Herdecke; 🇩🇪 Datteln, Germany

Ambulatory Obesity Program, Charité University, Berlin; 🇩🇪 Berlin, Germany

Center for Clinical Trials Essen; 🇩🇪 Essen, Germany

University Hospital Leipzig; 🇩🇪 Leipzig, Germany

Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic; 🇩🇪 Ulm, Germany

University Duisburg-Essen; 🇩🇪 Essen, Germany