NCT04185506

Brief Summary

The current study was a pilot study examining a novel treatment for weight loss and emotional eating. The intervention is a group-based approach, and it includes a focus on teaching emotion regulation skills from Dialectical Behavioral Therapy and traditional behavioral weight loss techniques. The goal of the study was to develop and refine the treatment protocol. Additional goals of the study were to evaluate feasibility and acceptability, to see whether the intervention could be administered and whether participants like the treatment and believe it helps them. Changes in weight and emotional eating from baseline to post-treatment will also be measured.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

December 4, 2019

Status Verified

December 1, 2019

Enrollment Period

3.6 years

First QC Date

November 27, 2019

Last Update Submit

December 2, 2019

Conditions

Keywords

emotional eatingDialectical Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

  • change in body weight

    body weight measured in kilograms

    10 months

Secondary Outcomes (4)

  • change in body mass index (BMI)

    10 months

  • change in emotional eating

    10 months

  • change in emotion regulation

    10 months

  • change in use of Dialectical Behavior Therapy (DBT) skills

    10 months

Study Arms (1)

DBT and behavioral weight loss

EXPERIMENTAL

The intervention is a 16-week group-based behavioral program consisting of a combination of Dialectical Behavioral Therapy (DBT) skills and behavioral weight loss techniques.

Behavioral: DBT+BWL

Interventions

DBT+BWLBEHAVIORAL

DBT skills include a focus on emotion regulation, distress tolerance, and mindfulness techniques. BWL includes a focus on monitoring of food intake, calorie reduction, and dietary and physical activity education.

DBT and behavioral weight loss

Eligibility Criteria

Age22 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ability to read English at a 6th grade level
  • willingness and ability to participate in study-related assessments and treatment visits. - - Subjects also had to report elevated levels of emotional eating. Elevated self-reported emotional eating occurred when subjects' self-reported emotional eating score was above the mean at least one of the sub scales of the Emotional Eating Scale (depression ≥ 21; EES-anxiety/anger ≥ 17; EES-boredom ≥ 21).

You may not qualify if:

  • past or present medical condition that required physician monitoring to participate (i.e., history of coronary heart disease, hepatic disease, renal disease, stroke, seizures, or myocardial infarction; symptoms of angina; uncontrolled hypertension; diabetes; protein wasting disease/Cushing's syndrome; osteoarthritis; osteoporosis; orthopedic problems that would limit activity; or any other serious medical condition that would make physical activity unsafe)
  • concurrent psychotherapy treatment
  • concurrent enrollment in a weight loss program
  • unstable dosage of psychotropic medication in the previous 3 months
  • regular use of purging or other compensatory behaviors in the previous 3 months
  • psychiatric conditions that would interfere with study participation (e.g., psychosis, current alcohol or drug use disorder, severe depression or suicidal behaviors within the past month)
  • current use of weight altering medications (e.g., phentermine)
  • immediate plans for weight loss surgery
  • current pregnancy or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OverweightObesityEmotional Eating

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 27, 2019

First Posted

December 4, 2019

Study Start

April 16, 2016

Primary Completion

November 17, 2019

Study Completion

December 31, 2019

Last Updated

December 4, 2019

Record last verified: 2019-12