NCT02055391

Brief Summary

The purpose of this study is to determine whether a new weight loss treatment which incorporates behavioral weight loss skills and skills for learning how to identify, manage, and cope with emotions helps with weight loss and emotional eating in people who are overweight and eat in response to emotions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2009

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

September 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2011

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

February 5, 2014

Completed
Last Updated

February 5, 2014

Status Verified

February 1, 2014

Enrollment Period

1.4 years

First QC Date

August 15, 2011

Last Update Submit

February 4, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • weight change

    12 weeks and 20 weeks

Secondary Outcomes (1)

  • changes in emotional eating

    12 weeks and 20 weeks

Study Arms (2)

Behavioral Weight Loss

ACTIVE COMPARATOR

State of the art behavioral weight loss treatment

Behavioral: Behavioral Weight Loss

Enhanced Behavioral Weight Loss

EXPERIMENTAL

Combines behavioral weight loss skills with skills specifically targeting emotional eating.

Behavioral: Enhanced Behavioral Weight Loss

Interventions

Weekly group meetings addressing behavioral weight loss skills including calorie counting, exercise, behavior modification, environmental changes, and coping with triggers.

Behavioral Weight Loss

Weekly group meetings that combine behavioral weight loss skills (calorie counting, exercise, behavior modification, environmental changes) with skills to decrease emotional eating by learning ways to manage and cope with emotions without eating.

Enhanced Behavioral Weight Loss

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-smoker, free of diabetes, overweight and interested in losing weight, eat in response to emotions

You may not qualify if:

  • Diabetes, any major medical or psychiatric condition that would compromise ability to participate, hypertension, current mental health treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CORE

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (1)

  • Goldbacher E, La Grotte C, Komaroff E, Vander Veur S, Foster GD. An initial evaluation of a weight loss intervention for individuals who engage in emotional eating. J Behav Med. 2016 Feb;39(1):139-50. doi: 10.1007/s10865-015-9678-6. Epub 2015 Sep 4.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Edie M Goldbacher, PhD

    Universidad La Salle, Mexico

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 15, 2011

First Posted

February 5, 2014

Study Start

September 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

February 5, 2014

Record last verified: 2014-02

Locations