NCT02023515

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
3 years until next milestone

Results Posted

Study results publicly available

June 27, 2017

Completed
Last Updated

June 27, 2017

Status Verified

May 1, 2017

Enrollment Period

7 months

First QC Date

December 23, 2013

Results QC Date

March 22, 2017

Last Update Submit

May 3, 2017

Conditions

Metabolic Syndrome

Keywords

weight lossmetabolic syndromestressobesity

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

    Weight change from baseline to 20 weeks

    Weight change from baseline to 20 weeks

Secondary Outcomes (1)

  • Decrease in Stress

    PSS change from baseline to 20 weeks

Study Arms (2)

Stress Management

EXPERIMENTAL

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

standard behavioral weight loss

ACTIVE COMPARATOR

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

Interventions

Emotional brain trainingBEHAVIORAL

Stress management based program

Stress Management
Behavioral weight lossBEHAVIORAL

Standard behavioral weight loss

standard behavioral weight loss

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • be 25-55 years of age
  • have a BMI of \> 28 and \<45
  • own and use a smart phone.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Metabolic SyndromeWeight LossObesity

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition Disorders

Results Point of Contact

Title
Kelly Webber, PhD, RD, LD
Organization
UKentucky
kelly.webber@uky.edu
859-257-4351

Study Officials

  • Kelly H Webber, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Faculty

Study Record Dates

First Submitted

December 23, 2013

First Posted

December 30, 2013

Study Start

December 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

June 27, 2017

Results First Posted

June 27, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)