Structured Psychoeducation for Unemployed Adolescents With Extreme Obesity in a Multicenter Observational Study Focusing on Feasibility

NCT02607995 | Completed DMC

• 1 other identifier: U1111-1131-4384f
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity occurs more frequently in subjects of a lower socioeconomic status and is associated with a lower income and unemployment. On the other hand, there is limited access of individuals with low socioeconomic status to conventional obesity treatments and bariatric surgery. In STEREOplus the investigators will ascertain unemployed adolescents with obesity and extreme obesity at five job centers in the Ruhr area. Unemployed obese youths and young adults (BMI ≥ 30kg/m2) between the ages of 14 and 24.9 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 six group sessions of conventional obesity treatment over a three months period. After six months, participants will complete further questionnaires to evaluate the effects of the interventions on quality of life and psychosocial functioning. Weight status (BMI) will also be measured. Adolescents who attended at least five sessions and are interested in bariatric surgery will have access to a structured information and preparation program for bariatric surgery. The overall objective of STEREOplus is to generate data on the feasibility of the planned implementation of a treatment targeted to a high risk group with a low socioeconomic background in order to reduce treatment barriers.

Conditions

Obesity; Extreme Obesity

Outcome Measures

Primary Outcomes (3)

• Change in BMI

  The BMI will be measured and compared

  baseline and 6 months

• Adherence measured as the participation rate in the intervention

  Adherence will be measured as the participation rate in the intervention

  6 months

• Change in participation rate in the first and second labor market

  The number of patients able to integrate themselves into the job market will be assessed

  baseline and 6 months

Secondary Outcomes (7)

• Change in quality of life (DISABKIDS)

  baseline and 6 months

• Change in depression score (Beck Depression Inventory-II)

  baseline and 6 months

• Change in self-esteem (Rosenberg scale)

  baseline and 6 months

• Change in perceived stress (PSQ Fliege scale)

  baseline and 6 months

• Change in somatic and psychiatric disorders (standardized patient questionnaire)

  baseline and 6 months

Study Arms (1)

low key intervention

for the whole group

Behavioral: Behavioral standardized manual-based multidisciplinary routine care

Interventions

Behavioral standardized manual-based multidisciplinary routine care BEHAVIORAL

Behavioral standardized manual-based multidisciplinary routine care (lifestyle intervention). Six sessions offered over the course of three to six months with a focus on weight loss. The topics 1) causes, consequences and treatment options of obesity, 2) nutrition, 3) eating behaviors and problem solving strategies, 4) self esteem and emotional eating, 5) exercise, and 6) use of media will be covered.

low key intervention

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

obese adolescents or young adults presenting at 5 different job centers

You may qualify if:

• BMI ≥ 30 kg/m2
• written informed consent
• sufficient knowledge of the German language to participate in the intervention
• participation in subproject 1

You may not qualify if:

• any psychiatric disorder that requires inpatient treatment (e.g. psychotic disorder, severe depression with suicidal behavior)
• IQ \< 70

Sponsors & Collaborators

• University of Ulm: lead
• Center for Sepsis Control and Care, Germany: collaborator
• Zentrum für klinische Studien Essen: collaborator
• JobCenter Essen Mitte: collaborator
• Jobcenter Bottrop: collaborator
• Jobcenter Gelsenkirchen: collaborator
• Jobcenter Oberhausen: collaborator
• Jobcenter Mülheim an der Ruhr: collaborator
• Universität Duisburg-Essen: collaborator

Study Sites (1)

University Duisburg-Essen

Essen, 45147, Germany

Location

MeSH Terms

Conditions

Obesity; Obesity, Morbid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Johannes Hebebrand, Prof. Dr. med.

  Universität Duisburg-Essen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: November 18, 2015
• Study Start: May 28, 2015
• Primary Completion: December 4, 2017
• Study Completion: December 4, 2017
• Last Updated: June 13, 2018

Record last verified: 2018-06

Locations

DE (1)