Modified Body Project for Obesity

Overseen By KayLoni Olson

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: The Miriam Hospital

Must not be taking: Weight loss medications

Disqualifiers: Eating disorder, Pregnancy, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how an adapted version of the Body Project program can assist women with higher body weight in losing weight and improving body image. It examines the program's impact on concerns about weight and shape and its effectiveness in promoting weight loss. Participants will either learn about obesity and weight loss myths or engage in the Modified Body Project, a dissonance-based body acceptance intervention, followed by six months of lifestyle coaching. Women who wish to lose weight, have a BMI between 25-40, and can use a cell phone are well-suited for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative approaches to weight loss and body acceptance.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using weight loss medication or have had bariatric surgery.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Body Project program is safe and effective. Studies have found that it reduces risks for eating disorders, such as body dissatisfaction and the desire for extreme thinness. These studies included participants similar to those in this trial, such as young women seeking to improve their body image.

The program typically occurs in groups, either in person or online, and has proven effective with teenagers and young adults. Reports of harm or negative effects from participating in the Body Project are rare, indicating that the program is generally safe and well-received. Participants often report improved body image and reduced unhealthy eating habits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Modified Body Project for obesity because it combines two powerful approaches: debunking myths about weight loss and promoting long-term behavioral change. Unlike standard interventions that often focus on diet and exercise alone, this method starts with a unique four-week program aimed at changing perceptions about obesity and weight management. This is followed by six months of behavioral support, which helps participants make sustainable lifestyle changes. This dual approach aims to address both the psychological and behavioral aspects of weight loss, offering a comprehensive strategy that could lead to more effective and lasting results.

What evidence suggests that this trial's treatments could be effective for weight loss?

Research has shown that the Body Project helps reduce risk factors such as body dissatisfaction and the desire for extreme thinness, both linked to eating disorders. In a previous study, the Body Project more effectively prevented increases in Body Mass Index (BMI) than other methods. Participants who completed the program were 60% less likely to develop eating disorders in the future compared to non-participants. The Body Project also reduced eating problems and improved body image in various groups, including Saudi women. In this trial, participants in the "Modified Body Project" arm will undergo a four-week intervention followed by six months of behavioral weight management. These findings suggest that the Body Project can aid in weight management and enhance body image. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adult women with a BMI between 25-40 who are concerned about their weight and shape, as indicated by specific scores on an eating disorder questionnaire. Participants must want to lose weight, be able to do moderate exercise, and have personal access to a cell phone.

Inclusion Criteria

I want to lose weight.

Body Mass Index between 25-40

Eating Disorder Examination-Questionnaire weight concern subscale greater than or equal to 4

Exclusion Criteria

Substance use disorder

Pregnant

Childbirth/delivery within 9 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Modified Body Project

Participants receive a modified body image intervention for 4 weeks

4 weeks

Weekly sessions (in-person or virtual)

Behavioral Weight Management

Participants undergo a 6-month standard behavioral weight management treatment

24 weeks

Bi-weekly sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Facts about obesity
• Lifestyle intervention for weight loss
• Modified Body Project
• Myths about weight loss

Trial Overview

The study tests an adapted Body Project program aimed at reducing concerns about weight and body shape among women with higher body weights. It's a randomized trial that also looks into how this program might help participants lose weight.

How Is the Trial Designed?

Group I: Modified Body Project Experimental Treatment 2 Interventions

Participants will receive this four week intervention followed by 6 months of behavioral weight management

Group II: Facts about obesity, myths about weight loss Active Control 2 Interventions

Participants will receive this four week intervention followed by 6 months of behavioral weight management

Lifestyle intervention for weight loss is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Lifestyle intervention for weight loss for:

• Obesity
• Overweight

Approved in European Union as Lifestyle intervention for weight loss for:

• Obesity
• Overweight

Approved in Canada as Lifestyle intervention for weight loss for:

• Obesity
• Overweight

Who Is Running the Clinical Trial?

The Miriam Hospital

Lead Sponsor

Trials

252

Recruited

39,200+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A structured multidisciplinary non-surgical obesity therapy program led to significant weight loss over 52 weeks, with females losing an average of 19.6 kg and males 26.0 kg, demonstrating its effectiveness in treating obesity.

The program also resulted in a 50% reduction in the prevalence of metabolic syndrome and a decrease in hypertension rates from 47% to 29%, indicating substantial health benefits beyond weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter evaluation of an interdisciplinary 52-week weight loss program for obesity with regard to body weight, comorbidities and quality of life--a prospective study. Bischoff, SC., Damms-Machado, A., Betz, C., et al.[2021]

A lifestyle intervention program combining diet, exercise, and psychological support significantly improved lifestyle-related behaviors in 60 overweight and obese patients over 6 months, as evidenced by better scores in dietary caloric intake, physical activity, and healthy eating.

The program also led to positive changes in body composition parameters, indicating that such comprehensive interventions can effectively support weight management in a primary healthcare setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of a program for treatment of overweight and nonmorbid obesity in primary healthcare and its influence lifestyle modification]. Arrebola Vivas, E., Gómez-Candela, C., Fernández Fernández, C., et al.[2015]

Weight loss of just 5-10% can significantly improve health issues related to obesity, such as hypertension and type II diabetes, as shown in studies like the Diabetes Prevention Program, which found a 7% weight reduction reduced diabetes risk by 58%.

Behavioral treatments, which include diet changes, increased physical activity, and behavior therapy, are effective in achieving and maintaining this level of weight loss, promoting long-term health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle modification in the treatment of obesity: an educational challenge and opportunity. Jones, LR., Wilson, CI., Wadden, TA.[2007]

Lifestyle interventions that combine dietary changes, physical activity support, and weight management education are the first-line treatment for obesity, emphasizing their importance in addressing the global obesity epidemic.

The chapter highlights the need for personalized weight management programs to enhance effectiveness and long-term adherence, given the significant health risks associated with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss Strategies. Roberts, SB., Anton, S., Dao, MC.[2022]

A comprehensive lifestyle modification program can lead to a significant weight loss of about 10% of initial body weight within 16 to 26 weeks, especially when delivered through group or individual on-site treatments.

Long-term weight control is enhanced by ongoing contact with healthcare providers, high physical activity levels, and the use of medications alongside lifestyle changes, which also help in reducing cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle modification for the management of obesity. Wadden, TA., Butryn, ML., Wilson, C.[2022]

The Obesity Treatment Research Program (OTRP) at Mayo Clinic offers a comprehensive, year-long lifestyle intervention for obesity, combining nutritional changes, physical activity, and cognitive behavioral strategies to promote long-term adherence.

The program aims to identify patient characteristics that may predict treatment outcomes, aligning with national obesity management recommendations and supporting ongoing research initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methodology of a multispecialty outpatient Obesity Treatment Research Program. Mikhail, DS., Jensen, TB., Wade, TW., et al.[2020]

Short-term behavioral interventions for obesity typically result in an average weight loss of 10 kg during the program and 6.6 kg at one year follow-up, indicating some effectiveness in the short term.

To improve long-term weight management, a chronic disease model of obesity treatment is suggested, emphasizing the need for ongoing care and potentially incorporating highly structured diets and supervised exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral treatment of severe obesity. Wing, RR.[2018]

Lifestyle modification therapy can lead to a significant weight loss of 8-10% over approximately 30 weeks for overweight and obese patients, combining diet, exercise, and behavioral strategies.

To enhance the effectiveness and sustainability of this therapy, new strategies such as individualized treatment, remote delivery via phone or internet, and integration with community programs or bariatric surgery have shown promising results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle modification in the management of obesity: achievements and challenges. Dalle Grave, R., Calugi, S., El Ghoch, M.[2022]

A randomized controlled trial involving 88 patients with morbid obesity demonstrated that multistep cognitive behavioral therapy for obesity (CBT-OB) led to a significant mean weight loss of 15% after 12 months, with no weight regain observed between months 6 and 12.

CBT-OB has shown promising long-term results for managing obesity related to binge-eating disorder, and ongoing outpatient studies may further validate its effectiveness compared to standard weight-loss programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized multistep cognitive behavioral therapy for obesity. Dalle Grave, R., Sartirana, M., El Ghoch, M., et al.[2020]

Lifestyle modifications for treating obesity are challenging to implement and sustain long-term, highlighting the need for effective strategies.

Simple and cost-effective interventions have shown potential benefits in specific populations, suggesting that targeted approaches may improve obesity treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Lifestyle modification--a behavioral and educational challenge]. Tamir, O., Furmn-Assaf, S., Shemer, J.[2011]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6536334/

Meta-Analytic Review of Dissonance-Based Eating ...

Efficacy trials have found that the Body Project produced greater reductions in eating disorder risk factors (thin-ideal internalization, body dissatisfaction, ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01680224

Effectiveness Trial of a Dissonance-Based Obesity ...

A pilot trial found that this new Project Health intervention significantly reduced increases in BMI relative to both the Healthy Weight intervention and an ...

3.

jeatdisord.biomedcentral.com

jeatdisord.biomedcentral.com/articles/10.1186/s40337-023-00932-7

Effectiveness of virtually delivered Body Project groups to ...

Participants who complete the Body Project have shown a 60% reduction in future onset of EDs relative to assessment-only control participants [ ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1740144523000451

Dissonance-based prevention of eating pathology in non- ...

The Body Project was effective for Saudi women in reducing eating pathology, body image dissatisfaction, and depression, though not social anxiety.

5.

blueprintsprograms.org

blueprintsprograms.org/programs/836999999/body-project/

Body Project

Outcomes (Brief, over all studies)​​ Additional analyses showed significantly higher reliable change rates in bulimic symptoms and lower risk of obesity onset ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06893627

Body Project SMIL: Prevention of Eating Disorders Among ...

The Body Project SMIL tests the effectiveness of a virtual, peer-led intervention aimed at reducing body dissatisfaction and preventing eating disorders in ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0272735818300886

Meta-analytic review of dissonance-based eating disorder ...

Meta-analytic review of dissonance-based eating disorder prevention programs: Intervention, participant, and facilitator features that predict larger effects.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4053817/

Dissonance-Based Prevention of Eating Disorder Risk ...

Effectiveness trials confirm that the Body Project produces similar effects when high school and college counselors recruit at risk young women and deliver the ...