Clinical trial NCT02023515: Comparison of Two Programs for Weight Loss and Impact on Metabolic Syndrome
Official title: Comparison of Two Programs for Weight Loss and Impact on Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: weight loss
metabolic syndrome
stress
obesity
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-12-30
Enrollment: 49
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight Loss
timeFrame: Weight change from baseline to 20 weeks
Secondary outcomes:
measure: Decrease in Stress
timeFrame: PSS change from baseline to 20 weeks
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Kelly H Webber, PhD
role: PRINCIPAL_INVESTIGATOR
References: