ObesityNCT06151145
Stepped Care for Weight Loss Maintenance
A study testing SELF and STEP in people with Obesity, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study is a 3-group, parallel design, randomized controlled trial (RCT) in approximately 258 adults with obesity that will investigate whether a 16-week behavioral weight loss treatment and a 52-week stepped-care digital health intervention can improve the maintenance of a ≥ 5% weight loss. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- SELF and STEP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI>/=30 kg/m2 or >/=27 kg/m2 with an obesity-related complication
- 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
Who cannot join
- Serious medical condition or psychiatric condition that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to adhere to the behavioral recommendations of the program
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study is a 3-group, parallel design, randomized controlled trial (RCT) in approximately 258 adults with obesity that will investigate whether a 16-week behavioral weight loss treatment and a 52-week stepped-care digital health intervention can improve the maintenance of a ≥ 5% weight loss.
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.
Read more
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:
- Participants in the Usual Care group will be emailed monthly educational modules with information on maintaining weight loss.
- 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.
- 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.
- Conditions
- Obesity
- Being tested
- Usual care, SELF, STEP
- Keywords
- obesity, weight loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careBehavioural
Participants in usual care will be emailed monthly educational modules with information on maintaining weight loss.
SELFBehavioural
The SELF group will receive a wireless "smart" body weight scale and wearable physical activity tracker, and text messages.
STEPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Usual care Receives: Behavioral: Usual care |
| Text-message intervention with digital tools (SELF) | Experimental | Text-message intervention Receives: Behavioral: SELF |
| Stepped Care (STEP) | Experimental | Stepped care Receives: Behavioral: STEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight (kg) change for STEP versus usual care
Weight change (kg) for STEP versus usual care
Measured: Baseline, 52 weeks
Weight (kg) change for SELF versus usual care
Weight change (kg) for SELF versus usual care
Measured: Baseline, 52 weeks
Secondary outcomes (7)
Change in self-weighing frequency (days) for STEP and SELF versus usual care
Change in number of days of self-weighing for STEP and SELF versus usual care
Measured: Baseline, 52 weeks
Change in daily calorie intake for STEP and SELF vs usual care
Change in daily calorie intake measured using 24-hour dietary recalls for STEP and SELF versus usual care
Measured: Baseline, 52 weeks
Change in physical activity (minutes) for STEP and SELF versus usual care
Change in self-reported minutes of physical activity for STEP and SELF versus usual care
Measured: Baseline, 52 weeks
Weight (kg) change for STEP versus SELF
Weight change (kg) for STEP versus SELF
Measured: Baseline, 52 weeks
Change in days of self-weighing for STEP versus SELF
Self-weighing frequency for STEP versus SELF
Measured: Baseline, 52 weeks
Change in daily calorie intake for STEP versus SELF
Change in daily calorie intake measured using 24-hour dietary recalls for STEP versus SELF
Measured: Baseline, 52 weeks
Change in self-reported minutes of Physical activity for STEP versus SELF
Change in self-reported minutes of physical activity for STEP versus SELF
Measured: Baseline, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Feb 2024
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Ariana M Chao, PhD, CRNP, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151145
- Sponsor's protocol ID
- IRB00404188
- Other IDs
- R01NR020197
- Status last verified
- Jun 2026
- First submitted
- 21 Nov 2023
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Care for Weight Loss Maintenance
- ClinicalTrials.gov ID
- NCT06151145
- Acronym / sponsor ID
- IRB00404188
- Conditions
- Obesity
- Keywords
- obesity, weight loss
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a 3-group, parallel design, randomized controlled trial (RCT) in approximately 258 adults with obesity that will investigate whether a 16-week behavioral weight loss treatment and a 52-week stepped-care digital health intervention can improve the maintenance of a ≥ 5% weight loss.
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:
- Participants in the Usual Care group will be emailed monthly educational modules with information on maintaining weight loss.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Behavioral: Usual careUsual care |
| Text-message intervention with digital tools (SELF) | Experimental | Behavioral: SELFText-message intervention |
| Stepped Care (STEP) | Experimental | Behavioral: STEPStepped care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI>/=30 kg/m2 or >/=27 kg/m2 with an obesity-related complication
- 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
Key exclusion criteria (8 listed)
- Serious medical condition or psychiatric condition that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to adhere to the behavioral recommendations of the program
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual careParticipants in usual care will be emailed monthly educational modules with information on maintaining weight loss. | Behavioural | Usual care |
| SELFThe SELF group will receive a wireless "smart" body weight scale and wearable physical activity tracker, and text messages. | Behavioural | Text-message intervention with digital tools (SELF) |
| STEPThe 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. | Behavioural | Stepped Care (STEP) |
Primary outcome
Weight (kg) change for STEP versus usual care
Time frame: Baseline, 52 weeks
Weight change (kg) for STEP versus usual care
Weight (kg) change for SELF versus usual care
Time frame: Baseline, 52 weeks
Weight change (kg) for SELF versus usual care
7 secondary outcomes
Change in self-weighing frequency (days) for STEP and SELF versus usual care
Time frame: Baseline, 52 weeks
Change in daily calorie intake for STEP and SELF vs usual care
Time frame: Baseline, 52 weeks
Change in physical activity (minutes) for STEP and SELF versus usual care
Time frame: Baseline, 52 weeks
Weight (kg) change for STEP versus SELF
Time frame: Baseline, 52 weeks
Change in days of self-weighing for STEP versus SELF
Time frame: Baseline, 52 weeks
Change in daily calorie intake for STEP versus SELF
Time frame: Baseline, 52 weeks
Change in self-reported minutes of Physical activity for STEP versus SELF
Time frame: Baseline, 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariana M Chao, PhD, CRNP principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SELF and STEP in people with Obesity, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (kg) change for STEP versus usual care (time frame: Baseline, 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026; AzTrials last refreshed its copy on 2 Nov 2026.