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Optimizing Weight Loss Outcomes Through Body Image Enhancement

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental: Lifestyle Intervention with Body Image Treatment (LIBI)
Lifestyle Intervention (LI)
Sponsored by
Texas Tech University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age: 18 and older
  • Sex: Female
  • BMI of 25 kg/m2 or greater

Exclusion Criteria:

  • Participants unable or unwilling to provide informed consent
  • Participants who are pregnant or planning to become pregnant over the next 4 months
  • Participants who are breastfeeding or planning to breastfeed over the next 4 months
  • Participants who have received a diagnosis of diabetes (type I or II)
  • Participants who been told NOT to lose weight or exercise for any reason by a healthcare provider
  • Participants who currently have psychiatric illnesses (e.g., Psychosis, schizophrenia, bipolar disorder or severe depression/anxiety)
  • Participants who currently have persistent suicidal thoughts or have attempted suicide in the last year
  • Participants with a history of diagnosed eating disorders such as bulimia nervosa or anorexia nervosa.

Sites / Locations

  • Texas Tech University - Department of Nutritional Sciences
  • Nutrition & Metabolic Health Initiative

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lifestyle Intervention (LI)

Lifestyle Intervention with Body Image Treatment (LIBI)

Arm Description

Participants will receive a standard, 12-week, group-delivered cognitive behavioral lifestyle intervention for weight loss.

Participants will receive a standard, 12-week, group-delivered cognitive behavioral lifestyle intervention for weight loss supplemented with a novel body image intervention designed to address body image issues in the context of weight loss.

Outcomes

Primary Outcome Measures

Comparison of Weight
Changes in weight loss
Comparison of Body Fat Mass
Changes in body fat mass
Comparison of Blood Pressure
Changes in systolic blood pressure
Comparison of Blood Pressure
Changes in diastolic blood pressure
Comparison of Blood Pressure
Changes in resting heart rate
Comparison of Physical Activity Engagement
Increase in self-reported physical activity engagement
Comparison of Health Related Quality of Life
Increase in self-reported health related quality of life
Comparison of Body Image
Changes in attitudinal and perceptual body image

Secondary Outcome Measures

Comparison of Interoceptive Awareness
Changes in the ability to identify and respond appropriately to internal bodily signals
Comparison of General Self-Efficacy
Changes in self-perception of ability and competence to perform effectively across different tasks and situations
Comparison of Dieting Self-Efficacy
Changes in self-perception of adequately responding to scenario-based eating temptations
Comparison of Exercising Self-Efficacy
Changes in self-perception of belief in ability to continue exercising despite setbacks
Comparison of Fear of Negative Evaluation
Changes in self-reported apprehension about negative evaluations by others
Comparison of Motivation to Engage in Physical Activity
Changes in self-reported motivation to engage in physical activity

Full Information

First Posted
September 21, 2021
Last Updated
November 1, 2022
Sponsor
Texas Tech University
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1. Study Identification

Unique Protocol Identification Number
NCT05090293
Brief Title
Optimizing Weight Loss Outcomes Through Body Image Enhancement
Official Title
Optimizing Weight Loss Outcomes Through Body Image Enhancement
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
May 8, 2022 (Actual)
Study Completion Date
May 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Tech University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will examine if a standard group-delivered cognitive behavioral lifestyle intervention for weight loss can be improved via the incorporation of a novel body image intervention designed to address body image and improve weight loss outcomes in a sample of women with overweight/obesity.
Detailed Description
Weight loss is associated with improved morbidity and mortality in people with overweight/obesity. Lifestyle-focused interventions reliably produce modest weight loss. While some comprehensive multidisciplinary weight management interventions include behavioral and psychosocial aspects of behavior change, including brief body image education, few have focused substantially on body image as a potentially salient influence on motivation and/or successful outcomes. Body image is an individual's perception of their physical self. A common psychosocial correlate of obesity is body dissatisfaction, and research has shown that individuals with obesity are more often dissatisfied with their bodies than individuals without obesity. Multiple studies suggest that improving body image might enhance eating self-regulation during weight management interventions and engagement in physical activity. Additionally, negative body image has been associated with detrimental health outcomes, such as emotional eating and avoidance of physical activity. Although body image has been addressed in the context of obesity and weight management, it is often done in a cursory manner. To date, no weight loss programs have attempted to develop a novel body image intervention that specifically targets the necessary dichotomy between body acceptance and expectable desire for body changes in a weight loss program. As such, the investigators will examine if a standard group-delivered cognitive behavioral lifestyle intervention for weight loss can be improved via the incorporation of a novel body image intervention designed to address body image and improve weight loss outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Lifestyle Intervention (LI)
Arm Type
Active Comparator
Arm Description
Participants will receive a standard, 12-week, group-delivered cognitive behavioral lifestyle intervention for weight loss.
Arm Title
Lifestyle Intervention with Body Image Treatment (LIBI)
Arm Type
Experimental
Arm Description
Participants will receive a standard, 12-week, group-delivered cognitive behavioral lifestyle intervention for weight loss supplemented with a novel body image intervention designed to address body image issues in the context of weight loss.
Intervention Type
Behavioral
Intervention Name(s)
Experimental: Lifestyle Intervention with Body Image Treatment (LIBI)
Intervention Description
A body image protocol designed to improve outcomes in a group-delivered multidisciplinary weight loss program by addressing body acceptance within a context of positive behavior change and utilizing existing body discomfort and re-purposing it as an agent of motivation.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Intervention (LI)
Intervention Description
A multidisciplinary, group-delivered, multidisciplinary weight loss program addressing various lifestyle factors impacting weight loss.
Primary Outcome Measure Information:
Title
Comparison of Weight
Description
Changes in weight loss
Time Frame
Baseline (pre-intervention) and 14 weeks (post-intervention)
Title
Comparison of Body Fat Mass
Description
Changes in body fat mass
Time Frame
Baseline (pre-intervention) and 14 weeks (post-intervention)
Title
Comparison of Blood Pressure
Description
Changes in systolic blood pressure
Time Frame
Baseline (pre-intervention) and 14 weeks (post-intervention)
Title
Comparison of Blood Pressure
Description
Changes in diastolic blood pressure
Time Frame
Baseline (pre-intervention) and 14 weeks (post-intervention)
Title
Comparison of Blood Pressure
Description
Changes in resting heart rate
Time Frame
Baseline (pre-intervention) and 14 weeks (post-intervention)
Title
Comparison of Physical Activity Engagement
Description
Increase in self-reported physical activity engagement
Time Frame
Baseline (pre-intervention) and 14 weeks (post-intervention)
Title
Comparison of Health Related Quality of Life
Description
Increase in self-reported health related quality of life
Time Frame
Baseline (pre-intervention) and 14 weeks (post-intervention)
Title
Comparison of Body Image
Description
Changes in attitudinal and perceptual body image
Time Frame
Baseline (pre-intervention) and 14 weeks (post-intervention)
Secondary Outcome Measure Information:
Title
Comparison of Interoceptive Awareness
Description
Changes in the ability to identify and respond appropriately to internal bodily signals
Time Frame
Baseline (pre-intervention) and 14 weeks (post-intervention)
Title
Comparison of General Self-Efficacy
Description
Changes in self-perception of ability and competence to perform effectively across different tasks and situations
Time Frame
Baseline (pre-intervention) and 14 weeks (post-intervention)
Title
Comparison of Dieting Self-Efficacy
Description
Changes in self-perception of adequately responding to scenario-based eating temptations
Time Frame
Baseline (pre-intervention) and 14 weeks (post-intervention)
Title
Comparison of Exercising Self-Efficacy
Description
Changes in self-perception of belief in ability to continue exercising despite setbacks
Time Frame
Baseline (pre-intervention) and 14 weeks (post-intervention)
Title
Comparison of Fear of Negative Evaluation
Description
Changes in self-reported apprehension about negative evaluations by others
Time Frame
Baseline (pre-intervention) and 14 weeks (post-intervention)
Title
Comparison of Motivation to Engage in Physical Activity
Description
Changes in self-reported motivation to engage in physical activity
Time Frame
Baseline (pre-intervention) and 14 weeks (post-intervention)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age: 18 and older Sex: Female BMI of 25 kg/m2 or greater Exclusion Criteria: Participants unable or unwilling to provide informed consent Participants who are pregnant or planning to become pregnant over the next 4 months Participants who are breastfeeding or planning to breastfeed over the next 4 months Participants who have received a diagnosis of diabetes (type I or II) Participants who been told NOT to lose weight or exercise for any reason by a healthcare provider Participants who currently have psychiatric illnesses (e.g., Psychosis, schizophrenia, bipolar disorder or severe depression/anxiety) Participants who currently have persistent suicidal thoughts or have attempted suicide in the last year Participants with a history of diagnosed eating disorders such as bulimia nervosa or anorexia nervosa.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Binks, Ph.D.
Organizational Affiliation
Texas Tech University- Department of Nutritional Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Tech University - Department of Nutritional Sciences
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79409
Country
United States
Facility Name
Nutrition & Metabolic Health Initiative
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States

12. IPD Sharing Statement

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Optimizing Weight Loss Outcomes Through Body Image Enhancement

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