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Behavioural Intervention
Stepped Care for Obesity
N/A
Recruiting
Led By Ariana M Chao, PhD, CRNP
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
BMI >/= 30 kg/m2 or >/= 27 kg/m2 with an obesity-related complication
Age 18-70 years
Must not have
History of bariatric surgery
Weight loss of >5% in the previous 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 52 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will study if a combination of a 16-week weight loss treatment and a 52-week digital health program can help adults with obesity maintain a weight loss of at least 5%. Participants will
Who is the study for?
This trial is for adults aged 18-70 with obesity, defined as a BMI of at least 30 or at least 27 with an obesity-related complication. Participants must have lost at least 5% of their initial weight during the first phase of the study, be able to exercise, own a smartphone and have home wireless access.
What is being tested?
The trial tests three strategies for maintaining weight loss over a year after an initial successful dieting phase. Usual Care involves monthly educational emails; SELF includes smart scales, activity trackers, and daily texts; STEP has four escalating steps based on individual progress.
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include stress from lifestyle changes, frustration from possible weight regain despite efforts, physical strain from increased activity levels or dietary restrictions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is 30 or higher, or it's 27 or higher with an obesity-related health issue.
Select...
I am between 18 and 70 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had weight loss surgery in the past.
Select...
I have lost more than 5% of my weight in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 52 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Weight (kg) change for SELF versus usual care
Weight (kg) change for STEP versus usual care
Secondary study objectives
Change in daily calorie intake for STEP and SELF vs usual care
Change in daily calorie intake for STEP versus SELF
Change in days of self-weighing for STEP versus SELF
+4 moreOther study objectives
Cost effectiveness
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Text-message intervention with digital tools (SELF)Experimental Treatment1 Intervention
Text-message intervention
Group II: Stepped Care (STEP)Experimental Treatment1 Intervention
Stepped care
Group III: Usual careActive Control1 Intervention
Usual care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
STEP
2018
Completed Phase 3
~190
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,493 Total Patients Enrolled
45 Trials studying Obesity
7,878 Patients Enrolled for Obesity
National Institute of Nursing Research (NINR)NIH
606 Previous Clinical Trials
10,378,536 Total Patients Enrolled
16 Trials studying Obesity
3,190 Patients Enrolled for Obesity
Ariana M Chao, PhD, CRNPPrincipal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
71 Total Patients Enrolled
1 Trials studying Obesity
31 Patients Enrolled for Obesity