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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02023515
Recruitment Status : Completed
First Posted : December 30, 2013
Results First Posted : June 27, 2017
Last Update Posted : June 27, 2017
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Kelly Webber, University of Kentucky

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

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Behavioral: Emotional brain training Behavioral: Behavioral weight loss Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Weight Loss [ Time Frame: Weight change from baseline to 20 weeks ]
    Weight change from baseline to 20 weeks

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02023515

United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40506
Sponsors and Collaborators
Kelly Webber
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Kelly H Webber, PhD University of Kentucky

Responsible Party: Kelly Webber, Faculty, University of Kentucky Identifier: NCT02023515     History of Changes
Other Study ID Numbers: 1R56HL116517-01A1 ( U.S. NIH Grant/Contract )
1R56HL116517-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 30, 2013    Key Record Dates
Results First Posted: June 27, 2017
Last Update Posted: June 27, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kelly Webber, University of Kentucky:
weight loss
metabolic syndrome

Additional relevant MeSH terms:
Weight Loss
Metabolic Syndrome X
Pathologic Processes
Body Weight Changes
Body Weight
Signs and Symptoms
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases