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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16, week 28
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a modified weight loss program called the Body Project on women who want to lose weight. The study will look at how the program affects weight and body image concerns, as well as its
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the interventions involve lifestyle changes rather than medication, side effects may include typical reactions to new exercise regimens or diet adjustments such as muscle soreness or changes in digestive patterns.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 16, week 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16, week 28
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Weight and shape concern
Secondary study objectives
Momentary Weight and Shape Concern
Overeating
Other study objectives
Adherence to lifestyle intervention
Weight change
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Modified Body ProjectExperimental Treatment2 Interventions
Participants will receive this four week intervention followed by 6 months of behavioral weight management
Group II: Facts about obesity, myths about weight lossActive Control2 Interventions
Participants will receive this four week intervention followed by 6 months of behavioral weight management
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Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,448 Previous Clinical Trials
4,332,344 Total Patients Enrolled
470 Trials studying Obesity
590,011 Patients Enrolled for Obesity
The Miriam HospitalLead Sponsor
244 Previous Clinical Trials
37,818 Total Patients Enrolled
76 Trials studying Obesity
15,096 Patients Enrolled for Obesity
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