Clinical trial NCT05090293: Optimizing Weight Loss Outcomes Through Body Image Enhancement
Official title: Optimizing Weight Loss Outcomes Through Body Image Enhancement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Texas Tech University
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Comparison of Weight
timeFrame: Baseline (pre-intervention) and 14 weeks (post-intervention)
measure: Comparison of Body Fat Mass
timeFrame: Baseline (pre-intervention) and 14 weeks (post-intervention)
measure: Comparison of Blood Pressure
timeFrame: Baseline (pre-intervention) and 14 weeks (post-intervention)
measure: Comparison of Blood Pressure
timeFrame: Baseline (pre-intervention) and 14 weeks (post-intervention)
measure: Comparison of Blood Pressure
timeFrame: Baseline (pre-intervention) and 14 weeks (post-intervention)
measure: Comparison of Physical Activity Engagement
timeFrame: Baseline (pre-intervention) and 14 weeks (post-intervention)
measure: Comparison of Health Related Quality of Life
timeFrame: Baseline (pre-intervention) and 14 weeks (post-intervention)
measure: Comparison of Body Image
timeFrame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Secondary outcomes:
measure: Comparison of Interoceptive Awareness
timeFrame: Baseline (pre-intervention) and 14 weeks (post-intervention)
measure: Comparison of General Self-Efficacy
timeFrame: Baseline (pre-intervention) and 14 weeks (post-intervention)
measure: Comparison of Dieting Self-Efficacy
timeFrame: Baseline (pre-intervention) and 14 weeks (post-intervention)
measure: Comparison of Exercising Self-Efficacy
timeFrame: Baseline (pre-intervention) and 14 weeks (post-intervention)
measure: Comparison of Fear of Negative Evaluation
timeFrame: Baseline (pre-intervention) and 14 weeks (post-intervention)
measure: Comparison of Motivation to Engage in Physical Activity
timeFrame: Baseline (pre-intervention) and 14 weeks (post-intervention)
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University - Department of Nutritional Sciences
state: Texas
city: Lubbock
country: United States
facility: Nutrition & Metabolic Health Initiative
state: Texas
Study officials:
affiliation: Texas Tech University- Department of Nutritional Sciences
name: Martin Binks, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: