Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
180 participants
INTERVENTIONAL
2024-02-01
2028-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
16-week run-in (Phase 1). To qualify for randomization, participants must lose ≥ 5% of initial weight in the 16-week run-in. This loss will be achieved with the provision of weekly-group lifestyle counseling, which includes a partial meal replacement diet.
52-week randomized trial of 3 weight loss maintenance strategies (Phase 2): Participants who have achieved ≥ 5% weight loss during Phase 1 will be randomly assigned to 1 of 3 groups:
1. Participants in the Usual Care group will be emailed monthly educational modules with information on maintaining weight loss.
2. Participants in the SELF group will receive a wireless "smart" body weight scale and a wearable physical activity tracker, and daily text messages with tailored feedback to assist in weight loss maintenance.
3. Participants in the STEP group will be enrolled in an intervention that consists of 4 steps that are progressive and based on response to treatment. After 13 weeks at each step, participants who do not maintain a ≥5% weight loss or regain 2 percentage points of weight from the participants randomization value will move to a higher intensity step. Participants who maintain weight loss will stay at the same step.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluating the Effectiveness of a Stepped-Care Approach to Long-Term Weight Loss (The Step-Up Study)
NCT00714168
Preventing Weight Gain Among Those Who Decline Behavioral Weight Loss Treatment (STEADY)
NCT04751656
Keep It Off: A Weight Loss Maintenance Study
NCT00702455
Sharing Digital Self-Monitoring Data With Others to Enhance Long-Term Weight Loss
NCT05180448
Study of a Personalized vs. Standard Approach to Weight Loss Recommendations
NCT04639076
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Usual care
Usual care
Usual care
Participants in usual care will be emailed monthly educational modules with information on maintaining weight loss.
Text-message intervention with digital tools (SELF)
Text-message intervention
SELF
The SELF group will receive a wireless "smart" body weight scale and wearable physical activity tracker, and text messages.
Stepped Care (STEP)
Stepped care
STEP
The STEP intervention consists of 4 steps that are progressive and based on response to treatment. Step 1: Digital health intervention. The first step will be the digital health intervention as described under SELF. Step 2: Monthly, in-person counseling. Participants who move to Step 2 will be provided with monthly, in-person counseling. Step 3: Twice per month counseling. Step 3 will be twice-monthly counseling, spaced at every other week. Step 4: Meal replacements. Participants will be prescribed a partial meal replacement program.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Usual care
Participants in usual care will be emailed monthly educational modules with information on maintaining weight loss.
SELF
The SELF group will receive a wireless "smart" body weight scale and wearable physical activity tracker, and text messages.
STEP
The STEP intervention consists of 4 steps that are progressive and based on response to treatment. Step 1: Digital health intervention. The first step will be the digital health intervention as described under SELF. Step 2: Monthly, in-person counseling. Participants who move to Step 2 will be provided with monthly, in-person counseling. Step 3: Twice per month counseling. Step 3 will be twice-monthly counseling, spaced at every other week. Step 4: Meal replacements. Participants will be prescribed a partial meal replacement program.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age 18-70 years
* Completion of baseline assessment tasks
* Ability to engage in physical activity
* Own a smartphone capable of receiving text-messages and syncing to weight scales and physical activity trackers
* Home wireless access
Exclusion Criteria
* Pregnant or planning pregnancy in the next 1.5 years
* Weight\>440 lbs
* Planned move out of the area in the next 1.5 years
* Recently began a course of or changed the dosage of medication that can cause significant change in weight
* History of bariatric surgery
* Weight loss of \>5% in the previous 6 months
* Household member already participating in study
18 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Nursing Research (NINR)
NIH
Johns Hopkins University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ariana M Chao, PhD, CRNP
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Johns Hopkins University
Baltimore, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB00404188
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.