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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02023515
• Other study ID #: 1R56HL116517-01A1
• Status: Completed
• Phase: N/A
• First received: December 23, 2013
• Last updated: July 28, 2014
• Start date: December 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome
• Weight Loss

Intervention

Behavioral:
• Emotional brain training
Stress management based program
• Behavioral weight loss
Standard behavioral weight loss

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Kelly Webber	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Weight will be measured at baseline, 10, and 20 weeks.	outcome will be measured at 10 week midpoint and 20 week endpoint	No
Secondary	Stress	Stress will be measured by salivary cortisol and telomere length.	Measured at baseline, 10 and 20 weeks	No