Optimizing Weight Loss Outcomes Through Body Image Enhancement

November 1, 2022 updated by: Martin Binks, Texas Tech University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Lubbock, Texas, United States, 79409
        • Texas Tech University - Department of Nutritional Sciences
      • Lubbock, Texas, United States, 79410
        • Nutrition & Metabolic Health Initiative

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Lifestyle Intervention (LI)
Participants will receive a standard, 12-week, group-delivered cognitive behavioral lifestyle intervention for weight loss.
Behavioral: Lifestyle Intervention (LI)
A multidisciplinary, group-delivered, multidisciplinary weight loss program addressing various lifestyle factors impacting weight loss.
Experimental: Lifestyle Intervention with Body Image Treatment (LIBI)
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.
Behavioral: Experimental: Lifestyle Intervention with Body Image Treatment (LIBI)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparison of Weight
Time Frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Changes in weight loss
Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Body Fat Mass
Time Frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Changes in body fat mass
Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Blood Pressure
Time Frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Changes in systolic blood pressure
Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Blood Pressure
Time Frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Changes in diastolic blood pressure
Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Blood Pressure
Time Frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Changes in resting heart rate
Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Physical Activity Engagement
Time Frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Increase in self-reported physical activity engagement
Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Health Related Quality of Life
Time Frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Increase in self-reported health related quality of life
Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Body Image
Time Frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Changes in attitudinal and perceptual body image
Baseline (pre-intervention) and 14 weeks (post-intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison of Interoceptive Awareness
Time Frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Changes in the ability to identify and respond appropriately to internal bodily signals
Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of General Self-Efficacy
Time Frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Changes in self-perception of ability and competence to perform effectively across different tasks and situations
Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Dieting Self-Efficacy
Time Frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Changes in self-perception of adequately responding to scenario-based eating temptations
Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Exercising Self-Efficacy
Time Frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Changes in self-perception of belief in ability to continue exercising despite setbacks
Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Fear of Negative Evaluation
Time Frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Changes in self-reported apprehension about negative evaluations by others
Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Motivation to Engage in Physical Activity
Time Frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Changes in self-reported motivation to engage in physical activity
Baseline (pre-intervention) and 14 weeks (post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas Tech University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Martin Binks, Ph.D., Texas Tech University- Department of Nutritional Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 13, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 8, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 8, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TTUIRB2021-470

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

Rare Diseases

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Dietary Supplements

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