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

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

Detailed Description
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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.

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

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Behavioral: Emotional brain training
* Behavioral: Behavioral weight loss


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be 25-55 years of age have a BMI of > 28 and <45 meet criteria for at least one additional risk factor for metabolic syndrome (Participants will be screened for waist circumference and blood pressure to ensure inclusion in the study.) own and use a smart phone. Exclusion Criteria: have a medical diagnosis of orthopedic or joint problems that may prohibit regular exercise endorse any of the first three items on the Physical Activity Readiness Questionnaire (PAR-Q): heart problems, chest pain, faintness or dizzy spells endorse any of the other items on the PAR-Q without a physician's consent have had a hospitalization for a psychiatric disorder within the last year have a history of anorexia or bulimia nervosa have a medical diagnosis of cancer or HIV have a diagnosis of a major psychiatric disorder (i.e. bipolar disorder or schizophrenia) or taking anti-psychotic medications be pregnant, nursing, or planning to become pregnant within the study period be less than 9 months post-partum have a weight loss of > 10 pounds in the last six months be on more than two medications for hypertension control greater than stage 3 kidney disease be taking insulin to control diabetes be taking Coumadin be taking Lasix anyone, who in the opinion of the study investigators, would not be a good candidate for the study

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stress Management<br>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<br>* Stress management based program<br>|
| Active Comparator: standard behavioral weight loss<br>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<br>* Standard behavioral weight loss<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | Weight change from baseline to 20 weeks | Weight change from baseline to 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Stress | 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. | PSS change from baseline to 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight loss, metabolic syndrome, stress, obesity