Optimizing Weight Loss Outcomes Through Body Image Enhancement
1 other identifier
interventional
58
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2021
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 13, 2021
CompletedFirst Submitted
Initial submission to the registry
September 21, 2021
CompletedFirst Posted
Study publicly available on registry
October 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 8, 2022
CompletedNovember 3, 2022
November 1, 2022
8 months
September 21, 2021
November 1, 2022
Conditions
Outcome Measures
Primary Outcomes (8)
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 Outcomes (6)
Comparison of Interoceptive Awareness
Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of General Self-Efficacy
Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Dieting Self-Efficacy
Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Exercising Self-Efficacy
Baseline (pre-intervention) and 14 weeks (post-intervention)
Comparison of Fear of Negative Evaluation
Baseline (pre-intervention) and 14 weeks (post-intervention)
- +1 more secondary outcomes
Study Arms (2)
Lifestyle Intervention (LI)
ACTIVE COMPARATORParticipants will receive a standard, 12-week, group-delivered cognitive behavioral lifestyle intervention for weight loss.
Lifestyle Intervention with Body Image Treatment (LIBI)
EXPERIMENTALParticipants 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.
Interventions
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.
A multidisciplinary, group-delivered, multidisciplinary weight loss program addressing various lifestyle factors impacting weight loss.
Eligibility Criteria
You may qualify if:
- Age: 18 and older
- Sex: Female
- BMI of 25 kg/m2 or greater
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Texas Tech University - Department of Nutritional Sciences
Lubbock, Texas, 79409, United States
Nutrition & Metabolic Health Initiative
Lubbock, Texas, 79410, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Binks, Ph.D.
Texas Tech University- Department of Nutritional Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 21, 2021
First Posted
October 22, 2021
Study Start
September 13, 2021
Primary Completion
May 8, 2022
Study Completion
May 8, 2022
Last Updated
November 3, 2022
Record last verified: 2022-11