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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kelly Webber, University of Kentucky
ClinicalTrials.gov Identifier:
NCT02023515
First received: December 23, 2013
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Metabolic Syndrome
Behavioral: Emotional brain training
Behavioral: Behavioral weight loss

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Two Programs for Weight Loss and Impact on Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Weight loss [ Time Frame: outcome will be measured at 10 week midpoint and 20 week endpoint ] [ Designated as safety issue: No ]
    Weight will be measured at baseline, 10, and 20 weeks.


Secondary Outcome Measures:
  • Stress [ Time Frame: Measured at baseline, 10 and 20 weeks ] [ Designated as safety issue: No ]
    Stress will be measured by salivary cortisol and telomere length.


Estimated Enrollment: 50
Study Start Date: December 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 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.

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02023515

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40506
Sponsors and Collaborators
Kelly Webber
Investigators
Principal Investigator: Kelly H Webber, PhD University of Kentucky
  More Information

No publications provided

Responsible Party: Kelly Webber, Faculty, University of Kentucky
ClinicalTrials.gov Identifier: NCT02023515     History of Changes
Other Study ID Numbers: 1R56HL116517-01A1
Study First Received: December 23, 2013
Last Updated: February 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
weight loss
metabolic syndrome
stress
obesity

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

ClinicalTrials.gov processed this record on April 15, 2014