A Structured, Manual-Based Low-Level Intervention vs. Treatment as Usual Evaluated in a Randomized Controlled Trial for Adolescents with Extreme Obesity - the STEREO Trial

Abstract

Background: To compare efficacy and safety of a manual-based low-level psychological intervention with treatment as usual (weight loss treatment).

Methods: A two-armed randomized controlled trial without blinding and computer-based stratified block randomization included adolescents and young adults (14.0-24.9 years) with a BMI ≥ 30 kg/m2 at five German university hospitals. Primary outcomes were adherence (participation rate ≥ 5/6 sessions) and quality of life (DISABKIDS-37) 6 months after randomization. Secondary outcomes included depression, self-esteem, and perceived stress scores.

Results: Of 397 screened adolescents, 119 (mean BMI 40.4 ± 7.0 kg/m2, 49.6% female) were randomized to the manual-based low-level intervention (n = 59) or treatment as usual (n = 60). We observed no group difference for adherence (absolute risk reduction 0.4%, 95% CI -14.7% to 15.5%; p = 1.0) or health-related quality of life (score difference 8.1, 95% CI -2.1 to 18.3; p = 0.11). Among all secondary outcomes, we detected explorative evidence for an effect on the DISABKIDS-37 'social exclusion' subscale (score difference 15.5; 95% CI 1.6-29.4; p = 0.03). 18/19 adverse events occurred in 26 participants, none were classified as serious.

Conclusion: Adherence to a coping-oriented intervention was comparable to weight loss treatment, although it was weak in both interventions. Psychological interventions may help to overcome social isolation; further confirmation is required.

Trial registration: ClinicalTrials.gov NCT01703273.

Keywords: Adherence; Adolescents; Extreme obesity; HRQoL; Quality of life; Youth.

© 2017 The Author(s) Published by S. Karger GmbH, Freiburg.

Figures

Fig. 1

CONSORT 2010 Flow Diagram [28] for the STEREO trial. 1Note that adherence as part of the primary outcome will be available for all allocated participants. 2One participant had to be excluded from the per protocol analyses due to violations of inclusion/exclusion criteria that were noted after the randomization.