Comparison of Two Programs for Weight Loss and Impact on Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title: Comparison of Two Programs for Weight Loss and Impact on Metabolic Syndrome

Status Completed

Clinical Trial Summary

The purpose of this study is to learn the impact stress may have on weight management and emotional eating.

Clinical Trial Description

The investigator's long-term goal is to contribute to the development of empirically-based, clinically-useful weight loss and weight maintenance interventions. The objective in this application is to obtain proof of feasibility for a weight loss and maintenance intervention that addresses the underlying issue of stress, as an effective approach to long-term weight loss and maintenance. The central hypothesis for this application is that the weight management intervention utilizing stress management skills will produce weight loss and significant improvements in stress and metabolic syndrome biomarkers at 10 and 20 weeks follow-up. This hypothesis was formulated based upon data showing that stress is associated with increased risk of obesity and a few small studies that have shown this method of stress management can produce long-term weight loss and maintenance and decreased depression and stress. The rationale for the proposed studies is that proof of feasibility for such an intervention will enable subsequent definitive studies at the R01 level. If, however, the investigators were to unexpectedly disprove the concept, such a result would also be valuable because it would lead the investigators to shift focus and redistribute resources accordingly. To test the central hypothesis, and thereby accomplish the objective for this application, the following specific aims will be pursued:

1. Compare a stress management based program to a standard behavioral weight loss program for weight loss and cost-effectiveness. The approach will involve two different intervention groups. Group 1(control) will receive a standard behavioral weight loss program. Group 2 will receive a stress management based intervention built on research in neuroscience and principles of the attachment theory.

2. Determine secondary outcomes from both interventions, including stress as measured by salivary cortisol and telomere length; depression, disordered eating patterns, dietary intake, and physical activity. It is hypothesized that Group 2 will show greater improvements in all secondary outcomes at both 10 and 20 weeks follow-up than Group 1.

3. Establish proof of concept that decreases in stress variables are associated with improvement in weight and stress-related psychological variables.

At the completion of this study, the investigators expect to determine the type of intervention that produces the greatest weight loss in a community sample at 10 and 20 weeks follow-up. The investigators will also have determined what impact the two interventions have on secondary outcomes, including stress as measured by salivary cortisol and telomere length; depression, disordered eating patterns, dietary intake, and physical activity. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome
• Weight Loss

• NCT number: NCT02023515
• Study type: Interventional
• Source: University of Kentucky
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Completion date: July 2014