Comparison of Two Programs for Weight Loss and Impact on Metabolic Syndrome
|ClinicalTrials.gov Identifier: NCT02023515|
Recruitment Status : Completed
First Posted : December 30, 2013
Results First Posted : June 27, 2017
Last Update Posted : June 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Behavioral: Emotional brain training Behavioral: Behavioral weight loss||Not Applicable|
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:
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Two Programs for Weight Loss and Impact on Metabolic Syndrome|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Experimental: Stress Management
Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques.
Behavioral: Emotional brain training
Stress management based program
Active Comparator: standard behavioral weight loss
Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks
Behavioral: Behavioral weight loss
Standard behavioral weight loss
- Weight Loss [ Time Frame: Weight change from baseline to 20 weeks ]Weight change from baseline to 20 weeks
- Decrease in Stress [ Time Frame: PSS change from baseline to 20 weeks ]Stress was measured by the Perceived Stress Scale (PSS). This scale measures stress on a scale of 0 to 40 points. The results are reported as a total score on the scale. Higher numbers indicate more stress than lower numbers.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02023515
|United States, Kentucky|
|University of Kentucky|
|Lexington, Kentucky, United States, 40506|
|Principal Investigator:||Kelly H Webber, PhD||University of Kentucky|