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Completed

NCT Number: NCT05090293

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nutrition & Metabolic Health Initiative, Lubbock, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental: Lifestyle Intervention with Body Image Treatment (LIBI)

Behavioral

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)

Behavioral

A multidisciplinary, group-delivered, multidisciplinary weight loss program addressing various lifestyle factors impacting weight loss.

Primary outcomes

  1. Comparison of Weight

    Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)

    Changes in weight loss

  2. Comparison of Body Fat Mass

    Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)

    Changes in body fat mass

  3. Comparison of Blood Pressure

    Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)

    Changes in systolic blood pressure

  4. Comparison of Blood Pressure

    Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)

    Changes in diastolic blood pressure

  5. Comparison of Blood Pressure

    Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)

    Changes in resting heart rate

  6. Comparison of Physical Activity Engagement

    Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)

    Increase in self-reported physical activity engagement

  7. 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

  8. Comparison of Body Image

    Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)

    Changes in attitudinal and perceptual body image

Secondary outcomes

  1. Comparison of Interoceptive Awareness

    Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)

    Changes in the ability to identify and respond appropriately to internal bodily signals

  2. Comparison of General Self-Efficacy

    Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)

    Changes in self-perception of ability and competence to perform effectively across different tasks and situations

  3. Comparison of Dieting Self-Efficacy

    Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)

    Changes in self-perception of adequately responding to scenario-based eating temptations

  4. Comparison of Exercising Self-Efficacy

    Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)

    Changes in self-perception of belief in ability to continue exercising despite setbacks

  5. Comparison of Fear of Negative Evaluation

    Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)

    Changes in self-reported apprehension about negative evaluations by others

  6. Comparison of Motivation to Engage in Physical Activity

    Time frame: Baseline (pre-intervention) and 14 weeks (post-intervention)

    Changes in self-reported motivation to engage in physical activity

Sponsors and collaborators

Lead sponsor

Texas Tech University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 22, 2021
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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