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Behavioural Intervention

Text-message intervention with digital tools (SELF) 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 52 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Weight (kg) change for SELF versus usual care
Weight (kg) change for STEP versus usual care
Secondary outcome measures
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 more
Other outcome measures
Cost effectiveness

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
2014
Completed Phase 3
~80

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,837,317 Total Patients Enrolled
45 Trials studying Obesity
8,003 Patients Enrolled for Obesity
National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,381 Total Patients Enrolled
16 Trials studying Obesity
3,282 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being recruited for this ongoing study?

"Indeed, the details on clinicaltrials.gov highlight that this study is actively seeking volunteers. The trial was initially listed on February 1st, 2024, and its most recent update was made on February 7th, 2024. Enrollment aims to include 180 participants from a single site."

Answered by AI

Do I meet the criteria to participate in this medical research study?

"The clinical investigation is enrolling 180 individuals aged between 18 and 70 who are affected by obesity. Eligible participants must satisfy these conditions: BMI of at least 30 kg/m2 or a minimum of 27 kg/m2 with an obesity-linked complication, age within the range of 18 to 70 years, successful completion of initial evaluation tasks, capability to partake in physical exercises, possession of a smartphone capable of accepting text notifications and syncing with weight scales as well as activity monitors, along with access to home wireless networks."

Answered by AI

Do individuals aged above 80 years meet the criteria for participating in this research study?

"Patients must be aged between 18 and 70 to meet the entry criteria for this study. Specifically, there are a total of 182 trials tailored for individuals younger than 18 years old and another batch of 687 studies catering to those older than 65."

Answered by AI

What is the current number of participants receiving treatment in this particular study?

"Indeed, details on clinicaltrials.gov highlight the ongoing recruitment efforts for this research study. The trial was first uploaded on 2nd January 2024 and last modified on 7th February 2024. It aims to enroll a total of 180 participants from one designated site."

Answered by AI

What are the main goals being pursued in this research endeavor?

"This study aims to assess the impact of STEP compared to standard care on weight change (measured in kilograms) over a 52-week period from baseline. Secondary measurements include changes in physical activity duration (in minutes) for participants following STEP and SELF interventions versus those receiving usual care, defined as alterations in self-reported physical activity time for individuals under STEP and SELF treatments relative to standard care; variations in frequency of self-weighing among those undergoing STEP versus SELF strategies, described as the rate of self-weighings between these groups; and adjustments in the frequency of self-weighing days for participants engaging with STEP or SELF approaches compared to those"

Answered by AI
~120 spots leftby Jun 2028