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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotional brain training
Behavioral weight loss
Sponsored by
Kelly Webber
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring weight loss, metabolic syndrome, stress, obesity

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stress Management

standard behavioral weight loss

Arm Description

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.

Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks

Outcomes

Primary Outcome Measures

Weight Loss
Weight change from baseline to 20 weeks

Secondary Outcome Measures

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.

Full Information

First Posted
December 23, 2013
Last Updated
May 3, 2017
Sponsor
Kelly Webber
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02023515
Brief Title
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kelly Webber
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
weight loss, metabolic syndrome, stress, obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stress Management
Arm Type
Experimental
Arm Description
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.
Arm Title
standard behavioral weight loss
Arm Type
Active Comparator
Arm Description
Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks
Intervention Type
Behavioral
Intervention Name(s)
Emotional brain training
Intervention Description
Stress management based program
Intervention Type
Behavioral
Intervention Name(s)
Behavioral weight loss
Intervention Description
Standard behavioral weight loss
Primary Outcome Measure Information:
Title
Weight Loss
Description
Weight change from baseline to 20 weeks
Time Frame
Weight change from baseline to 20 weeks
Secondary Outcome Measure Information:
Title
Decrease in Stress
Description
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.
Time Frame
PSS change from baseline to 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly H Webber, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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