Optimizing Weight Loss Outcomes Through Body Image Enhancement

Overweight and Obesity Clinical Trial

Official title:

Optimizing Weight Loss Outcomes Through Body Image Enhancement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05090293
• Other study ID #: TTUIRB2021-470
• Status: Completed
• Phase: N/A
• Start date: September 13, 2021
• Est. completion date: May 8, 2022

Study information

• Verified date: November 2022
• Source: Texas Tech University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 8, 2022
• Est. primary completion date: May 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

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.
• Lifestyle Intervention (LI)
A multidisciplinary, group-delivered, multidisciplinary weight loss program addressing various lifestyle factors impacting weight loss.

Locations

Country	Name	City	State
United States	Nutrition & Metabolic Health Initiative	Lubbock	Texas
United States	Texas Tech University - Department of Nutritional Sciences	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Weight	Changes in weight loss	Baseline (pre-intervention) and 14 weeks (post-intervention)
Primary	Comparison of Body Fat Mass	Changes in body fat mass	Baseline (pre-intervention) and 14 weeks (post-intervention)
Primary	Comparison of Blood Pressure	Changes in systolic blood pressure	Baseline (pre-intervention) and 14 weeks (post-intervention)
Primary	Comparison of Blood Pressure	Changes in diastolic blood pressure	Baseline (pre-intervention) and 14 weeks (post-intervention)
Primary	Comparison of Blood Pressure	Changes in resting heart rate	Baseline (pre-intervention) and 14 weeks (post-intervention)
Primary	Comparison of Physical Activity Engagement	Increase in self-reported physical activity engagement	Baseline (pre-intervention) and 14 weeks (post-intervention)
Primary	Comparison of Health Related Quality of Life	Increase in self-reported health related quality of life	Baseline (pre-intervention) and 14 weeks (post-intervention)
Primary	Comparison of Body Image	Changes in attitudinal and perceptual body image	Baseline (pre-intervention) and 14 weeks (post-intervention)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Comparison of Fear of Negative Evaluation	Changes in self-reported apprehension about negative evaluations by others	Baseline (pre-intervention) and 14 weeks (post-intervention)
Secondary	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)