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



Status:Completed
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:25 - 55
Updated:3/1/2014
Start Date:December 2013
End Date:July 2014
Contact:Kelly H Webber, PhD
Email:khwebb2@uky.edu
Phone:859-257-4351

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

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.

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
We found this trial at
1
site
Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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