Optimizing Weight Loss Outcomes Through Body Image Enhancement

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: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: Lifestyle Intervention (LI); Behavioral: Experimental: Lifestyle Intervention with Body Image Treatment (LIBI)

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: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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)

Collaborators and Investigators

• Sponsor: Texas Tech University
• Investigators: Principal Investigator: Martin Binks, Ph.D., Texas Tech University- Department of Nutritional Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Actual): May 8, 2022
• Study Completion (Actual): May 8, 2022

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID 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