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

60 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the Modified Body Project for Obesity treatment?

Research shows that lifestyle modifications, including diet and physical activity, can lead to significant weight loss and health improvements. Behavioral therapy, a key component of the Modified Body Project, has been shown to help people adopt and maintain healthier habits, leading to weight loss and reduced risk of conditions like type II diabetes. ^{1 2 3 4 5}

Is the Modified Body Project for Obesity safe for humans?

Lifestyle interventions for obesity, which include diet, physical activity, and behavior therapy, are generally considered safe and are recommended as the first line of treatment for obesity. These interventions have been shown to induce significant weight loss and improve health conditions like type II diabetes and cardiovascular risk factors. ^{1 4 6 7 8}

How is the Modified Body Project for Obesity treatment different from other obesity treatments?

The Modified Body Project for Obesity is unique because it combines lifestyle interventions like diet and exercise with behavioral therapy to help change eating habits, making it a comprehensive approach to weight loss. Unlike some treatments that focus solely on diet or exercise, this program integrates multiple strategies to support long-term weight management. ^{2 4 5 9 10}

What is the purpose of this trial?

This study is a randomized controlled trial to evaluate the effect of an adapted version of the Body Project program among adult women of higher body weight who want to lose weight. The study will evaluate treatment effects on weight and shape concern and explore the impact of intervention on weight loss outcomes.

Eligibility Criteria

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.

I am female.

Eating Disorder Examination-Questionnaire shape concern subscale greater than or equal to 4.25

Exclusion Criteria

Substance use disorder

Pregnant

Childbirth/delivery within 9 months

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Lifestyle modification in the treatment of obesity: an educational challenge and opportunity. [2007]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Personalized multistep cognitive behavioral therapy for obesity. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Behavioral treatment of severe obesity. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Weight Loss Strategies. [2022]

5. Israel pubmed.ncbi.nlm.nih.gov

[Lifestyle modification--a behavioral and educational challenge]. [2011]

6. United States pubmed.ncbi.nlm.nih.gov

Lifestyle modification for the management of obesity. [2022]

7. Spain pubmed.ncbi.nlm.nih.gov

[Effectiveness of a program for treatment of overweight and nonmorbid obesity in primary healthcare and its influence lifestyle modification]. [2015]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Methodology of a multispecialty outpatient Obesity Treatment Research Program. [2020]

9. England 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. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Lifestyle modification in the management of obesity: achievements and challenges. [2022]