Clinical Research Directory

FlexED: National Substudy

The purpose of this study is to test the feasibility of disseminating an intervention broadly. "FlexED" is a digital gamified intervention targeting eating disorder symptoms in young women and girls at risk by changing how they experience thoughts and feelings about their body. The digital intervention is based on Acceptance and Commitment Therapy (ACT). Participants complete seven 20-minute sessions of the intervention using their smartphone over about 8 weeks. Participants also complete questionnaires bi-weekly as they go through the intervention. A final measurement is taken one month after the last digital intervention session. These surveys are all conducted online. Participants are in the study for up to 12 weeks.

Intuitive Eating Intervention After Bariatric Surgery

This study evaluated the validity and reliability of the Turkish version of the Intuitive Eating Scale-2 (IES-2) in individuals who had undergone bariatric surgery and examined the effects of a 6-week online intuitive eating intervention. The study consisted of two stages. In the first stage, 297 adults aged 18-65 years who had undergone bariatric surgery were included to evaluate the psychometric properties of the Turkish IES-2. Exploratory and confirmatory factor analyses, internal consistency, and test-retest reliability were assessed. In the second stage, a 6-week prospective, non-randomized controlled intervention study was conducted among 60 individuals who had undergone bariatric surgery at least two years previously and had regained at least 20% of their maximum weight loss. Participants received either an online intuitive eating intervention or standard nutritional counseling. Outcomes included intuitive eating behaviors, eating attitudes, body perception, body weight, and body mass index (BMI). The Turkish IES-2 demonstrated a valid and reliable three-factor, 17-item structure. The intervention was associated with improvements in intuitive eating behaviors and reductions in eating attitude scores, while no significant changes were observed in body weight or BMI. The findings suggest that an online intuitive eating intervention may improve intuitive eating behaviors and some eating attitudes among individuals who regain weight after bariatric surgery.

Impact of Adolescence Body Image on Body Functionality and Physical Activity

This cross-sectional study will investigate how Egyptian adolescents aged 14-17 years perceive their bodies and how these perceptions are related to body functionality and physical activity. The study will examine different patterns of body image concerns, including high, moderate, and low concern, and explore whether these patterns are associated with how adolescents appreciate what their bodies can do and how physically active they are. Participants will complete questionnaires assessing body shape concerns, body appreciation and functionality, and physical activity. The study aims to improve understanding of the relationship between body image, body functionality, and physical activity during adolescence and may provide useful information for healthcare professionals, particularly physical therapists, when developing strategies to promote physical activity and overall well-being among adolescents.

FlexED: A Digital, Gamified Early Intervention for Eating Disorders

The goal of this clinical trial is to test a new intervention for body-image distress to reduce eating disorder symptoms in young women and girls between the ages of 15-25 years old. Participants complete up to 8 digital sessions using their mobile phone that include a character, story line and interactive exercises, games and digital rewards. Everyone in the study completes the intervention after different periods of time (2, 4 or 6 weeks) of completing assessments. Researchers will examine the impact of the intervention on participants ability to respond flexibly to body-image distress or triggers, measuring things like heart rate, eye gaze, and reaction time to body-image related words and images, and test how long it takes to see change.

Collagen Supplements and Post-MBS Muscle Mass/Body Image

This prospective, observational cohort study aims to evaluate whether the use of collagen-containing supplements is associated with differences in muscle mass, body composition, and body image among patients who have undergone sleeve gastrectomy (SG). The study will be conducted at the General Surgery outpatient clinic of a private hospital in Bursa, Türkiye, between May 2026 and March 2027, and will enroll adult patients (aged 18-65 years) who meet current ASMBS/IFSO eligibility criteria for metabolic and bariatric surgery. Participants will be naturally allocated into two observational groups based on their own choice to use or not use collagen-containing supplements; no supplement will be provided or recommended by the study team, and no intervention will be made to participants' standard clinical care. All patients will be followed according to routine clinical practice preoperatively and at 2 weeks, 1 month, 3 months, and 6 months postoperatively. Primary outcome measures include anthropometric parameters (body weight, BMI, fat mass, fat mass percentage, fat-free mass, muscle mass, percentage of weight loss, percentage of excess weight loss, waist and hip circumference) assessed via bioelectrical impedance analysis (Tanita MC-780 MA), and body image assessed using the Turkish-validated Body Shape Questionnaire (BSQ). Secondary outcomes include biochemical parameters, comorbidities, and macronutrient intake data obtained from 3-day dietary records analyzed using the BEBİS nutrition software. The study hypothesizes that patients using collagen-containing supplements will show significant differences in muscle mass and body composition parameters compared with non-users, and that supplement use will be significantly associated with BSQ scores. A sample size of approximately 52 participants per group was calculated using G\*Power 3.1 (one-way ANOVA, Cohen's f = 0.25, α = 0.05, power = 0.80).

Prospective Evaluation of Body Image, Physical, Psychological, Sexual, and Social Outcomes After Posterior Aesthetic Rib Remodeling

This prospective observational cohort will evaluate patient-reported and anthropometric outcomes after posterior aesthetic rib remodeling. Selected BODY-Q scales will measure body image, physical, psychological, sexual, and social function before surgery and through 12 months. Standardized waist and hip measurements will be collected at the same visits. The primary outcome is change in BODY-Q Body Image score at one year, and analyses will assess whether patient-reported improvement is associated with sustained waist reduction.

Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT

In this multi-center randomized clinical trial, head and neck cancer (HNC) survivors with clinically significant body image distress (BID) (N=180) will be randomized to BRIGHT (a brief video tele-cognitive behavioral therapy intervention) or Attention Control (AC, a manualized tele-supportive care intervention that controls for professional attention, dose, delivery method, and common factors). HNC survivors will complete IMAGE-HN (a validated patient-reported outcome measure \[PROM\] of HNC-related body image distress \[BID\]; primary endpoint), measures of psychological and social well-being and quality of life (QOL), and measures of theory-derived mechanisms of change underlying BRIGHT (mediators).

FlexED: Full Threshold ED Substudy

The purpose of this study is to test whether a new digital intervention decreases eating disorder symptoms in young women with eating disorders by changing how they experience thoughts and feelings about their body. The digital intervention is based on Acceptance and Commitment Therapy (ACT). Participants complete up to 7 digital intervention sessions using their mobile phone that include a character, story line and interactive exercises, games and digital rewards. Researchers will examine the impact of the intervention on participants' ability to respond flexibly to body-image distress or triggers, measuring things like heart rate, eye movements, and reaction time to body-image related words and images, and examine changes in eating disorder symptoms before and after intervention.

The Weight of Victory: Exploring Short- and Long-term Health Outcomes in Former Male & Female Elite Athletes From Weight-sensitive Sports

The health of former elite athletes has been identified as a critical research gap where there is limited knowledge about both short- and long-term consequences after ending their careers. The transition phase from an active elite career to everyday life has been shown to be particularly problematic, yet this issue has been little studied among former Norwegian elite athletes. Furthermore, questions remain regarding the health of athletes from weight-sensitive sports, such as weight-class, aesthetic, and certain endurance sports. These athletes face specific challenges related to maintaining a certain physique and frequent changes in body weight during their active careers. This group has been shown to be vulnerable to a range of problematic health outcomes related to low energy availability, and little is known about the long-term effects of a career involving this. Therefore, the overall purpose of the project is to map the mental and physical health of former elite athletes. At the same time, there will be a particular focus on the differences between weight-sensitive and less weight-sensitive sports, different types of sports, gender, as well as previous dieting and eating behaviors.

Yoga 4 Body Image (Y4BI): Investigating the Impact of Yoga on Body Image and Eating Behaviours

The practice of yoga can positively impact body image, a psychological construct encompassing perceptual, emotional, cognitive, and behavioral aspects, which can be either positive or negative. Negative body image manifests as extreme dissatisfaction with one's body-a condition particularly common among young women-that places them at significant risk for developing Body Image Disorders (BIDs). In contrast, positive body image is characterized by an overall respect for one's body. Current research on the impact of yoga on body image has several limitations, making it challenging to determine whether yoga practice truly has a positive effect on body image and to identify the mechanisms underlying this impact. To address these gaps, the present project aims to overcome the limitations of existing studies by investigating the impact of yoga on body image through quantitative methodologies and by exploring the mechanisms that drive this effect. The project consists of two phases: 1. Investigating the impact of yoga on body image (both positive and negative) and eating behaviours in a population characterized by high levels of body dissatisfaction-young women. 2. Examining the psychological mechanisms underlying yoga's impact on body image, including increased interoceptive awareness, embodiment, and self-compassion, as well as a reduction in self-objectification.

Strong Minds: A Digital Intervention Targeting Body Image and Psychological Well-being Among Adolescent Male Fitness Club Members

The purpose of this study is to evaluate whether a digital intervention can improve body image and psychological well-being among adolescent boys who attend fitness clubs. Fitness club environments and social media often promote appearance ideals related to muscularity and leanness, which may contribute to body appearance pressure, body dissatisfaction, and psychological distress among boys. In this cluster-randomized controlled trial, approximately 260 boys aged 15 to 18 years will be recruited from fitness clubs in Oslo, Norway. Participants from fitness clubs assigned to the intervention group will receive access to a 12-week website-based program consisting of four interactive modules focusing on body image, psychological well-being, critical social media literacy, and attitudes toward food and sports supplements. Participants in the control group will continue their usual activities. The study will examine whether the intervention reduces internalization of appearance ideals and body appearance pressure and improves body appreciation, health-related quality of life, psychological well-being, social media-related behaviors, and attitudes toward food and sports supplements. Outcomes will be assessed at baseline, immediately after the intervention, and at a 6-month follow-up.

MBSR Effects on Aging Anxiety and Body Image

This study was designed to determine the effect of a mindfulness-based stress reduction (MBSR) program on aging anxiety and body image among middle-aged women. The primary hypotheses to be tested are as follows: H0a: There is no difference in the mean scores of the Aging Anxiety Scale between the women in the experimental group who receive the mindfulness-based stress reduction program and the women in the control group. H0b: There is no difference in the mean scores of the Body Image Scale between the women in the experimental group who receive the mindfulness-based stress reduction program and the women in the control group. H0c: There is no difference between the pre-intervention and post-intervention mean scores of the Aging Anxiety Scale among the women in the experimental group who receive the mindfulness-based stress reduction program. H0d: There is no difference between the pre-intervention and post-intervention mean scores of the Body Image Scale among the women in the experimental group who receive the mindfulness-based stress reduction program. The researchers will compare the experimental group with the control group in order to assess the effect of the mindfulness-based stress reduction program on aging anxiety and body image among middle-aged women. Participants: * They will attend an 8-session mindfulness-based stress reduction program. * They will participate in one silent mindfulness retreat session.

The Impact of a Podcast-based Body Image Intervention Among Millennial Women

The goal of this three-arm randomized controlled trial is to evaluate the acceptability and efficacy of two podcast-based interventions -- a podcast with an accompanying journal and the same podcast without a journal -- which aim to improve body confidence among millennial-aged women (29-44 years of age) in the United Kingdom. A total of 1800 women in the UK (29-44 years), who are podcast listeners, will be recruited by a research agency. Participants will be randomised to one of three groups: body confidence podcast episode with journal; body confidence podcast episode alone; a non-body confidence-related podcast episode from the same series as the intervention podcast. The research aims are to determine the following: 1. Are the two versions of the intervention (i.e., podcast with and without a journal) effective in improving appearance esteem (primary outcome), internalisation of appearance ideals, self-objectification, and weight esteem among UK-based women (i) 1 day post-intervention and (ii) 1 week post-intervention, compared to a control podcast? 2. Are the two interventions (i.e., podcast with and without a journal) effective in generating immediate change in state body satisfaction and state mood, compared to a control podcast? 3. Are the two versions of the intervention acceptable to women?

Effects of Stoma Education on Patients

tomas are classified according to the anatomical region in which they are created and the surgical technique used. Stomas that open into the large intestine are called colostomies, those that open into the small intestine are called ileostomies, and the creation of an anastomosis of the ureters to the abdominal wall is called a urostomy. Stomas are commonly used in the treatment of gastrointestinal diseases. Ileostomy and colostomy are the most frequently encountered types of stomas. While colorectal cancer is the primary reason for intestinal stoma creation, inflammatory bowel diseases, penetrating abdominal injuries, congenital anomalies, obstructions due to diverticular disease, ischemic colitis, radiation injury, sigmoid colon volvulus, and fecal incontinence are also among the indications for stoma creation. Despite advances in surgical techniques, complications are commonly seen in individuals with stomas. Incorrect stoma placement, the use of inappropriate bags and adapter systems, and a lack of knowledge and skills among patients and caregivers play a significant role in the development of complications. Depending on these conditions, patients may encounter problems such as edema, bleeding, ischemia, and mucocutaneous dehiscence in the early postoperative period. These complications negatively affect not only physical health but also the individual's social life, psychological state, and overall quality of life. Symptoms such as peristomal skin problems, uncontrolled gas release, fecal incontinence, and pain can hinder participants' adaptation to daily life and lead to social isolation. Nursing care and patient education are of great importance in managing these problems faced by individuals with stomas. The nursing process requires a comprehensive approach extending from the pre-operative period to the post-discharge phase. In this process, individualized education programs addressing fundamental issues such as nutrition, elimination, sexuality, social participation, and privacy should be implemented to improve quality of life, develop self-care skills, and prevent complications. In this context, the investigators have planned this study to determine the effects of the education provided to patients on stoma adaptation, body image, and self-efficacy.

Non-Diet Nutrition Education and Its Effects on Eating Behavior, Body Image, and Well-Being in Adult Women

The goal of this clinical trial is to evaluate whether a non-diet nutrition education program can improve eating behaviors, body image, and well-being in normal-BMI women aged 19-35 years. The main questions it aims to answer are: * Does participation in an 8-week non-diet nutrition education program improve eating behavior, body image, and well-being over time in the intervention group compared to the control group? * Is there a significant difference between the intervention and control groups in eating behavior, body image, and well-being after the intervention? Researchers will compare an intervention group receiving an 8-week non-diet nutrition education with a control group receiving no intervention, to see if the program leads to improvements in psychological and behavioral outcomes without focusing on weight loss. Participants will: * Complete pre- and post-intervention assessments, including validated questionnaires on eating behavior (DEBQ, FCQ, IES-2), body image (BAS, Stunkard Figure Rating Scale), and psychological well-being (WHO-5, Rosenberg Self-Esteem Scale), as well as a 3-day food diary. * Be randomly assigned to either the intervention group (8-week online non-diet nutrition education sessions) or the control group (no intervention). * Engage in 8 weekly, 60-minute sessions focused on intuitive eating, body acceptance, and health-promoting nutrition.

Assessing the Efficacy of a Song to Improve Body Appreciation Among Young Children

The goal of this randomised controlled trial has two aims: Do UK-based children ages 4 to 6 years understand a evidence-informed song with body confidence messaging without visual aids? and Does children's body appreciation improve after listening to the intervention song, relative to an active control? Children in primary school will be randomised to an intervention condition or active control condition at the individual level. Assessments will occur through one-on-one structured play-based questions assessing body appreciation, message comprehension, and intervention acceptability.

3D Reconstruction, VR and Machine Learning in Body Image in Bariatrics

Studies have shown that following bariatric metabolic surgery (BMS), patients continue to experience dissatisfaction with their new body image and identity). The reason for this is poorly understood but negative body image perception after surgery is linked to poor psychological and clinical outcomes. Our pilot study looking at the acceptability and feasibility of 3D reconstruction and virtual reality (VR) in addressing body image in BMS found that participants felt better informed about how their body will change following significant weight loss and agreed this novel intervention would be beneficial in helping patients adjust to changes in their body after BMS. The investigators propose a randomised control trial comparing group body image counselling and group body image counselling with 3D reconstruction and VR in addressing body image in BMS. The study aims to enrol 80 participants from the Tier 4 bariatric group at St Mary's Hospital and Chelsea \& Westminster Hospital. After consent, participants will be divided into two groups: the control group will receive traditional group body image counselling, and the intervention group will receive the same counselling supplemented with VR and 3D reconstructed images depicting 15% and 25% total less body weight. Both groups will undergo four sessions over six months. The investigators will collect data including body measurements and 3D images of the participant in their underwear using a secure password protected device at baseline and follow participants at 3, 6, 9, 12, 18, 24, and 36 months post-BMS. Patient reported outcomes will be assessed through patient-reported questionnaires. This trial seeks to determine if integrating 3D reconstruction and VR technology into body image counselling can provide better support for patients adjusting to body image changes post-BMS, potentially leading to improved psychological and clinical outcomes.

Brief Single-Session Body Neutrality Program for LGBTQ+ Adults in Central Alabama

LGBTQ+ individuals tend to have elevated risks for eating disorders (ED), possibly due to minority stress. For LGBTQ+ individuals living in rural Alabama, they tend to experience high levels of anti-LGBTQ+ structural stigma and limited access to LGBTQ+-specific resources, which engender compounded risk for ED development and reduced access to care. Brief digital single-session intervention that incorporates psychoeducation about minority stress and body neutrality may be efficacious in reducing ED risk and improve positive body image among LGBTQ+ adults in rural areas. Prior research from another lab developed a single-session intervention (Project Body Neutrality) among LGBTQ+ adolescents indicated immediate positive changes in body image constructs and psychological well-being. The present project evaluates and adapts Project Body Neutrality, specifically for LGBTQ+ adults in a rural high-stigma, low-resource region.

Hybrıd Educatıon Based on Psychodynamıc Nursıng Theory of Women Undergoıng Mastectomy

Our study aims to investigate the effects of planned hybrid (web-based and face-to-face) group training to be given to women with mastectomies based on Psychodynamic nursing theory, on women's body value, social appearance anxiety and sexual life quality. Power analysis was performed for the study group of the study and intervention and control groups were created by randomization method (intervention group n = 30, control group n = 30). The study will be applied as a pretest-posttest experimental intervention method. In order to make an evaluation before and after the planned hybrid training, the situations that are most affected by women after mastectomy were analyzed in line with the literature and the data were collected from the Sociodemographic Characteristics Form, Body Value Scale-2, Social Appearance Anxiety Scale (SAAS), Sexual Quality of Life Scale-Female (SQOL-W). will be collected using. A standard information brochure containing information about mastectomy will be given to the intervention and control groups after the pre-test. Then, hybrid group training based on Psychodynamic Nursing Theory will be given to the intervention group by the researcher. A Whatsapp group will also be established to enable patients to communicate and ask questions. During the process, 9 web-based and 3 face-to-face group trainings will be held. A posttest will be administered to both groups at the end of the last group training, and a permanence test will be administered 1 month later via Google surveys on the Whatsapp group. SPPS program and Pearson Chi-square test, Independent Samples Test, McNemar, Pearson Chi-square test, ANOVA (Repeated Measures ANOVA) will be used to analyze the data. As a result of the study, in line with the research findings, the effect of hybrid group training based on Psychodynamic Nursing Theory on the body value, social appearance anxiety and sexual life quality of women who have undergone mastectomy will be evaluated.

Prenatal Yoga Intervention in Pregnant Women

The aim of this study is to determine the effects of a prenatal yoga intervention on traumatic childbirth perception, self-perception, and delivery preferences in pregnant women.

WISH, Feasibility of a Factorial Design

The primary aim of this study is to evaluate the feasibility of testing a multi-component intervention for sexual function using a factorial design.

Relationships Between Nomophobia Levels and Perceived Stress, Body Image and Food Addiction Among University Students

The purpose of this study is to examine the effects of nomophobia levels on stress, food addiction, and body image among undergraduate students aged 18-30 at Bahçeşehir University, Faculty of Health Sciences. The primary questions it aims to answer are: * Is there a statistically significant relationship between nomophobia levels and perceived stress, food addiction, and body image among university students? * Is there a correlation between objective anthropometric data (body fat percentage, skeletal muscle mass) measured via Bioelectrical Impedance Analysis (BIA), waist/hip circumference measurements, and the individual's perceived body image?

Effect of Skin Closure Techniques on Body Image in Women Undergoing Gynecologic Surgery

This randomized clinical trial investigates the impact of two different skin closure techniques on body image and mood in women undergoing surgery for gynecologic cancers. Patients undergoing elective surgery with a midline abdominal incision will be randomly assigned to one of two groups: 1. Interrupted Closure Group: The surgical incision is closed using either metal clips (staples) or separate mattress sutures (individual stitches). 2. Subcuticular Sutures Group: The surgical incision is closed using continuous stitches placed under the skin surface (aesthetic stitching). The main goal of the study is to determine whether the method of wound closure affects a patient's perception of their body image, cosmetic satisfaction, and levels of anxiety or depression. Additionally, the study aims to prove that the subcuticular suture technique is safe and does not increase the risk of wound complications (such as infection or wound separation) compared to the other method. Participants will be asked to complete questionnaires before surgery, and again at 1, 3 and 6 months after surgery to track changes in their feelings and satisfaction with the scar.

SDT-Based Intervention for Exercise Motivation in Female Students

Physical inactivity, maladaptive exercise motives, and body image concerns are highly prevalent among young adult women and are associated with reduced psychological well-being and increased risk for disordered eating. This study protocol describes a randomized controlled trial designed to evaluate a multi-component psychoeducational intervention integrating Self-Determination Theory principles with functionality-oriented body image strategies to enhance autonomous motivation for exercise and promote psychological well-being among female university students. Female Health Sciences students aged 18-25 will be randomly allocated (1:1) to an experimental or control group following baseline assessment, and outcomes will be evaluated at baseline, post-intervention, and six-week follow-up. The six-session face-to-face intervention incorporates autonomy-supportive communication, competence-building activities, meaningful rationales, choice provision, and supportive relational climates, combined with functionality-based body image content. The primary outcome is autonomous motivation for exercise (BREQ-3; Relative Autonomy Index), and secondary outcomes include basic psychological need satisfaction and frustration, physical activity levels, positive body image, and eating disorder risk. Linear mixed-effects models will be used under an intention-to-treat approach, and mediation analyses will test whether changes in psychological need satisfaction underlie improvements in motivational quality. The intervention is expected to promote healthier motivational regulation, increase physical activity engagement, strengthen positive body image, and reduce maladaptive exercise drivers. Findings aim to inform scalable, theory-driven preventive strategies for improving health and well-being among young women in university settings.