Optimizing Weight Loss Outcomes Through Body Image Enhancement

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimizing Weight Loss Outcomes Through Body Image Enhancement

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: Experimental: Lifestyle Intervention with Body Image Treatment (LIBI)
* Behavioral: Lifestyle Intervention (LI)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lifestyle Intervention (LI)<br>Participants will receive a standard, 12-week, group-delivered cognitive behavioral lifestyle intervention for weight loss. | Behavioral: Lifestyle Intervention (LI)<br>* A multidisciplinary, group-delivered, multidisciplinary weight loss program addressing various lifestyle factors impacting weight loss.<br>|
| Experimental: Lifestyle Intervention with Body Image Treatment (LIBI)<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Weight | Changes in weight loss | Baseline (pre-intervention) and 14 weeks (post-intervention) | 
| Comparison of Body Fat Mass | Changes in body fat mass | Baseline (pre-intervention) and 14 weeks (post-intervention) | 
| Comparison of Blood Pressure | Changes in systolic blood pressure | Baseline (pre-intervention) and 14 weeks (post-intervention) | 
| Comparison of Blood Pressure | Changes in diastolic blood pressure | Baseline (pre-intervention) and 14 weeks (post-intervention) | 
| Comparison of Blood Pressure | Changes in resting heart rate | Baseline (pre-intervention) and 14 weeks (post-intervention) | 
| Comparison of Physical Activity Engagement | Increase in self-reported physical activity engagement | Baseline (pre-intervention) and 14 weeks (post-intervention) | 
| Comparison of Health Related Quality of Life | Increase in self-reported health related quality of life | Baseline (pre-intervention) and 14 weeks (post-intervention) | 
| Comparison of Body Image | Changes in attitudinal and perceptual body image | Baseline (pre-intervention) and 14 weeks (post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Interoceptive Awareness | 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 | 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 | 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 | 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 | 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 | Changes in self-reported motivation to engage in physical activity | Baseline (pre-intervention) and 14 weeks (post-intervention) |