Comparison of Two Programs for Weight Loss and Impact on Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome; Weight Loss
Study type: Interventional

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

Detailed 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
           the perceived stress scale. It is hypothesized that Group 2 will show greater
           improvements in stress at both 10 and 20 weeks follow-up than Group 1.

      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.
    

Intervention name(s): Emotional brain training; Behavioral weight loss
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Stress management based program; Standard behavioral weight loss
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: weight loss; metabolic syndrome; stress; obesity