Overweight and ObesityNCT05090293
Optimizing Weight Loss Outcomes Through Body Image Enhancement
A study testing Experimental: Lifestyle Intervention with Body Image Treatment (LIBI) and Lifestyle Intervention (LI) in people with Overweight and Obesity, run by Texas Tech University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Experimental: Lifestyle Intervention with Body Image Treatment (LIBI) and Lifestyle Intervention (LI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Sep 2021to 8 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18 and older
- Sex: Female
- BMI of 25 kg/m2 or greater
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Tech University - Department of Nutritional Sciences
Lubbock, Texas, 79409
Nutrition & Metabolic Health Initiative
Lubbock, Texas, 79410
About this study
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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- Experimental: Lifestyle Intervention with Body Image Treatment (LIBI), Lifestyle Intervention (LI)
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Lifestyle Intervention with Body Image Treatment (LIBI)Behavioural
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.
Lifestyle Intervention (LI)Behavioural
A multidisciplinary, group-delivered, multidisciplinary weight loss program addressing various lifestyle factors impacting weight loss.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention (LI) | Active comparator | Participants will receive a standard, 12-week, group-delivered cognitive behavioral lifestyle intervention for weight loss. Receives: Behavioral: Lifestyle Intervention (LI) |
| Lifestyle Intervention with Body Image Treatment (LIBI) | Experimental | 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. Receives: Behavioral: Experimental: Lifestyle Intervention with Body Image Treatment (LIBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Weight
Changes in weight loss
Measured: Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Body Fat Mass
Changes in body fat mass
Measured: Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Blood Pressure
Changes in systolic blood pressure
Measured: Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Blood Pressure
Changes in diastolic blood pressure
Measured: Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Blood Pressure
Changes in resting heart rate
Measured: Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Physical Activity Engagement
Increase in self-reported physical activity engagement
Measured: Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Health Related Quality of Life
Increase in self-reported health related quality of life
Measured: Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Body Image
Changes in attitudinal and perceptual body image
Measured: Baseline (pre-intervention) and 14 weeks (post-intervention)
Secondary outcomes (6)
Comparison of Interoceptive Awareness
Changes in the ability to identify and respond appropriately to internal bodily signals
Measured: Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of General Self-Efficacy
Changes in self-perception of ability and competence to perform effectively across different tasks and situations
Measured: Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Dieting Self-Efficacy
Changes in self-perception of adequately responding to scenario-based eating temptations
Measured: Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Exercising Self-Efficacy
Changes in self-perception of belief in ability to continue exercising despite setbacks
Measured: Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Fear of Negative Evaluation
Changes in self-reported apprehension about negative evaluations by others
Measured: Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Motivation to Engage in Physical Activity
Changes in self-reported motivation to engage in physical activity
Measured: Baseline (pre-intervention) and 14 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start13 Sep 2021
- Primary completion8 May 2022
- Study completion8 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Binks, Texas Tech University
- Investigators
- Martin Binks, Ph.D., Principal investigator, Texas Tech University- Department of Nutritional Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090293
- Sponsor's protocol ID
- TTUIRB2021-470
- Status last verified
- Nov 2022
- First submitted
- 21 Sep 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Weight Loss Outcomes Through Body Image Enhancement
- ClinicalTrials.gov ID
- NCT05090293
- Acronym / sponsor ID
- TTUIRB2021-470
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 8 May 2022 (actual)
- Study completion
- 8 May 2022 (actual)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention (LI) | Active comparator | Behavioral: Lifestyle Intervention (LI)Participants will receive a standard, 12-week, group-delivered cognitive behavioral lifestyle intervention for weight loss. |
| Lifestyle Intervention with Body Image Treatment (LIBI) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 18 and older
- Sex: Female
- BMI of 25 kg/m2 or greater
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Lifestyle Intervention with Body Image Treatment (LIBI) |
| Lifestyle Intervention (LI)A multidisciplinary, group-delivered, multidisciplinary weight loss program addressing various lifestyle factors impacting weight loss. | Behavioural | Lifestyle Intervention (LI) |
Primary outcome
Comparison of Weight
Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Changes in weight loss
Comparison of Body Fat Mass
Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Changes in body fat mass
Comparison of Blood Pressure
Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Changes in systolic blood pressure
Comparison of Blood Pressure
Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Changes in diastolic blood pressure
Comparison of Blood Pressure
Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Changes in resting heart rate
Comparison of Physical Activity Engagement
Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Increase in self-reported physical activity engagement
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
Comparison of Body Image
Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Changes in attitudinal and perceptual body image
6 secondary outcomes
Comparison of Interoceptive Awareness
Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of General Self-Efficacy
Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Dieting Self-Efficacy
Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Exercising Self-Efficacy
Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Fear of Negative Evaluation
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Binks, Ph.D. principal investigator
Texas Tech University- Department of Nutritional Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Lifestyle Intervention with Body Image Treatment (LIBI) and Lifestyle Intervention (LI) in people with Overweight and Obesity, run by Texas Tech University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Weight (time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.