Anorexia NervosaREACH+NCT04810624
Relapse Prevention and Changing Habits in Anorexia Nervosa
A study testing Relapse Prevention and Changing Habits (REACH+) in people with Anorexia Nervosa, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This study aims to optimize a treatment package for the relapse prevention treatment of AN. In the Preparation Phase, we examined accessibility and feasibility of the treatment package. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Relapse Prevention and Changing Habits (REACH+)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2021to 1 Jun 2027
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Anorexia Nervosa at hospital admission
- Medically Stable
- Internet capability with videoconferencing
- Weight restored (BMI > 19 kg/m2) at New York State Psychiatric Institute
Who cannot join
- Current substance use or other comorbid disorder requiring specialized treatment
- Pregnancy
- Imminent risk of suicide
- Serious medical illness
- Daily psychotropic medication other than antidepressants (medications that are known effect weight are exclusionary, i.e. stimulants, olanzapine, mirtazapine)
- Participation in outside psychotherapy or structured treatment program (support groups will be allowed). Individuals who are discharged on medications would need to have a non-study psychiatrist.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
New York State Psychiatric Institute
New York, New York, 10032
Joanna Steinglass, MD, 6467746345, js1124@cumc.columbia.edu
Joanna Steinglass, MD
About this study
Official title: Optimizing Relapse Prevention and Changing Habits in Anorexia Nervosa
This study aims to optimize a treatment package for the relapse prevention treatment of AN. In the Preparation Phase, we examined accessibility and feasibility of the treatment package.
In the current Optimization Phase, we will identify which components of treatment contribute to positive outcomes after acute hospitalization. We will carefully evaluate maintenance of remission, measured by rate of weight loss and end-of-trial status.
Read the detailed description
While many approaches to reducing relapse after hospital care have been tried, there is little information about which treatment elements confer benefit. This trial, Relapse Prevention and Changing Habits (REACH+), targets the habitual control of maladaptive behavior to support patients with AN in the 6 months after acute treatment, a time of high vulnerability to relapse. Each component of REACH+ addresses a question that is critical to answer in order to identify and optimize a relapse prevention treatment package that balances efficacy and burden. We will test the acceptability and feasibility of 5 components that together target habits: 1) Behavioral, 2) Cognitive, 3)Motivation, 4) Food Monitoring, and 5) Skill Consolidation. In the Preparation Phase, 10 participants were enrolled, and accessibility and feasibility of the treatment package was examined. The current Optimization Phase includes a finalized treatment manual (including an online platform) and will test each component's contribution to weight maintenance after acute treatment.
- Conditions
- Anorexia Nervosa
- Being tested
- Relapse Prevention and Changing Habits (REACH+)
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relapse Prevention and Changing Habits (REACH+)Behavioural
Psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| Do, Accept, Motivation Through Values, Sessions, Long-Term Food Logs, | Experimental | Behavior Do: Including in-session eating experiments.
Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior.
Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity.
Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions.
Food Monitoring - Long-Term: Use of food logs for duration of treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Do, Accept, Motivation through Values, Sessions, Short-Term Food Logs | Experimental | Behavior Do: Including in-session eating experiments.
Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior.
Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity.
Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions.
Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Do, Accept, Motivation through Values, Check-Ins, Short-Term Food Logs | Experimental | Behavior Do: Including in-session eating experiments.
Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior.
Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity.
Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period.
Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Do, Accept, Motivation through Values, Check-Ins, No Food Logs | Experimental | Behavior Do: Including in-session eating experiments.
Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior.
Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity.
Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period.
No Food-Monitoring: No recommendation for food records or logs during treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Do, Accept, Motivation through Narratives, Sessions, Short-Term Food Logs | Experimental | Behavior Do: Including in-session eating experiments.
Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior.
Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators.
Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions.
Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Do, Accept, Motivation through Narratives, Sessions, No Food Logs | Experimental | Behavior Do: Including in-session eating experiments.
Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior.
Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators.
Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions.
No Food-Monitoring: No recommendation for food records or logs during treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Do, Accept, Motivation through Narratives, Check-Ins, Long-Term Food Logs | Experimental | Behavior Do: Including in-session eating experiments.
Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior.
Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators.
Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period.
Food Monitoring - Long-Term: Use of food logs for duration of treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Do, Change, Motivation Through Values, Sessions, Short-Term Food Logs | Experimental | Behavior Do: Including in-session eating experiments.
Thought Change: Monitoring and actively challenging distorted thoughts.
Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity.
Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions.
Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Do, Change, Motivation Through Values, Sessions, No Food Logs | Experimental | Behavior Do: Including in-session eating experiments.
Thought Change: Monitoring and actively challenging distorted thoughts.
Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity.
Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions.
No Food-Monitoring: No recommendation for food records or logs during treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Do, Change, Motivation through Values, Check-Ins, Long-Term Food Logs | Experimental | Behavior Do: Including in-session eating experiments.
Thought Change: Monitoring and actively challenging distorted thoughts.
Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity.
Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period.
Food Monitoring - Long-Term: Use of food logs for duration of treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Do, Change, Motivation Through Narratives, Sessions, Long-term Food Logs | Experimental | Behavior Do: Including in-session eating experiments.
Thought Change: Monitoring and actively challenging distorted thoughts.
Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators.
Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions.
Food Monitoring - Long-Term: Use of food logs for duration of treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Talk, Accept, Motivation through Values, Sessions, Short-Term Food Logs | Experimental | Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments.
Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior.
Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity.
Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions.
Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Talk, Accept, Motivation through Values, Sessions, No Food Logs | Experimental | Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments.
Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior.
Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity.
Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions.
No Food-Monitoring: No recommendation for food records or logs during treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Talk, Accept, Motivation through Narratives, Check-Ins, Short-Term Food Logs | Experimental | Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments.
Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior.
Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators.
Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period.
Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Talk, Accept, Motivation through Narratives, Check-Ins, No Food Logs | Experimental | Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments.
Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior.
Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators.
Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period.
No Food-Monitoring: No recommendation for food records or logs during treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Talk, Change, Motivation Through Values, Sessions, Long-Term Food Logs | Experimental | Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments.
Thought Change: Monitoring and actively challenging distorted thoughts.
Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity.
Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions.
Food Monitoring - Long-Term: Use of food logs for duration of treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Talk, Change, Motivation Through Values, Sessions, No Food Logs | Experimental | Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments.
Thought Change: Monitoring and actively challenging distorted thoughts.
Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity.
Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions.
No Food-Monitoring: No recommendation for food records or logs during treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Talk, Change, Motivation through Values, Check-Ins, Short-Term Food Logs | Experimental | Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments.
Thought Change: Monitoring and actively challenging distorted thoughts.
Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity.
Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period.
Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Talk, Change, Motivation through Values, Check-Ins, No Food Logs | Experimental | Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments.
Thought Change: Monitoring and actively challenging distorted thoughts.
Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity.
Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period.
No Food-Monitoring: No recommendation for food records or logs during treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Talk, Change, Motivation through Narratives, Sessions, Short-Term Food Logs | Experimental | Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments.
Thought Change: Monitoring and actively challenging distorted thoughts.
Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators.
Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions.
Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Talk, Change, Motivation through Narratives, Sessions, No Food Logs | Experimental | Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments.
Thought Change: Monitoring and actively challenging distorted thoughts.
Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators.
Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions.
No Food-Monitoring: No recommendation for food records or logs during treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Talk, Change, Motivation through Narratives, Check-Ins, Long-Term Food Logs | Experimental | Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments.
Thought Change: Monitoring and actively challenging distorted thoughts.
Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators.
Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period.
Food Monitoring - Long-Term: Use of food logs for duration of treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Do, Change, Motivation through Narratives, Check-Ins, Short-Term Food Logs | Experimental | Behavior Do: Including in-session eating experiments.
Thought Change: Monitoring and actively challenging distorted thoughts.
Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators.
Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period.
Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Do, Change, Motivation through Narratives, Check-Ins, No Food Logs | Experimental | Behavior Do: Including in-session eating experiments.
Thought Change: Monitoring and actively challenging distorted thoughts.
Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators.
Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period.
No Food-Monitoring: No recommendation for food records or logs during treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Talk, Accept, Motivation through Values, Check-Ins, Long-Term Food Logs | Experimental | Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments.
Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior.
Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity.
Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period.
Food Monitoring - Long-Term: Use of food logs for duration of treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
| Talk, Accept, Motivation through Narratives, Sessions, Long-Term Food Logs | Experimental | Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments.
Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior.
Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators.
Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions.
Food Monitoring - Long-Term: Use of food logs for duration of treatment. Receives: Behavioral: Relapse Prevention and Changing Habits (REACH+) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight maintenance
Measured via rate of weight loss (in lbs) following discharge from inpatient unit
Measured: 6-month end of treatment
Secondary outcomes (5)
Habit strength
Measured via Self-Report Habit Index (SRHI)
Measured: 6-month end of treatment
Weight/shape distortion
Measured via Eating Disorder Examination, Questionnaire Version (EDE-Q)
Measured: 6-month end of treatment
Intrinsic motivation
Measured via General Self-Efficacy Scale (GSES)
Measured: 6-month end of treatment
Dietary restriction
Measured via Food Choice Task
Measured: 6-month end of treatment
Skill consolidation
Measured via platform utilization time
Measured: 6-month end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
21 Jun 20211 Jun 2027
- First posted23 Mar 2021
- Study start21 Jun 2021
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna Steinglass, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810624
- Sponsor's protocol ID
- 8110
- Other IDs
- R34MH127180
- Acronym
- REACH+
- Status last verified
- Mar 2026
- First submitted
- 21 Jan 2021
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Steinglass JE, Attia E, Glasofer DR, Wang Y, Ruggiero J, Walsh BT, Thomas JG. Optimizing relapse prevention and changing habits (REACH+) in anorexia nervosa. Int J Eat Disord. 2022 Jun;55(6):851-857. doi: 10.1002/eat.23724. Epub 2022 Apr 30.
PubMed 35488866
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Relapse Prevention and Changing Habits in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT04810624
- Acronym / sponsor ID
- REACH+ / 8110
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Columbia University, Brown University, National Institute of Mental Health (NIMH)
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 23 Mar 2021 (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 aims to optimize a treatment package for the relapse prevention treatment of AN. In the Preparation Phase, we examined accessibility and feasibility of the treatment package.
In the current Optimization Phase, we will identify which components of treatment contribute to positive outcomes after acute hospitalization. We will carefully evaluate maintenance of remission, measured by rate of weight loss and end-of-trial status.
Detailed description
While many approaches to reducing relapse after hospital care have been tried, there is little information about which treatment elements confer benefit. This trial, Relapse Prevention and Changing Habits (REACH+), targets the habitual control of maladaptive behavior to support patients with AN in the 6 months after acute treatment, a time of high vulnerability to relapse. Each component of REACH+ addresses a question that is critical to answer in order to identify and optimize a relapse prevention treatment package that balances efficacy and burden. We will test the acceptability and feasibility of 5 components that together target habits: 1) Behavioral, 2) Cognitive, 3)Motivation, 4) Food Monitoring, and 5) Skill Consolidation. In the Preparation Phase, 10 participants were enrolled, and accessibility and feasibility of the treatment package was examined. The current Optimization Phase includes a finalized treatment manual (including an online platform) and will test each component's contribution to weight maintenance after acute treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 26
| Arm | Type | Receives |
|---|---|---|
| Do, Accept, Motivation Through Values, Sessions, Long-Term Food Logs, | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Do: Including in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. Food Monitoring - Long-Term: Use of food logs for duration of treatment. |
| Do, Accept, Motivation through Values, Sessions, Short-Term Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Do: Including in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment. |
| Do, Accept, Motivation through Values, Check-Ins, Short-Term Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Do: Including in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment. |
| Do, Accept, Motivation through Values, Check-Ins, No Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Do: Including in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. No Food-Monitoring: No recommendation for food records or logs during treatment. |
| Do, Accept, Motivation through Narratives, Sessions, Short-Term Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Do: Including in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment. |
| Do, Accept, Motivation through Narratives, Sessions, No Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Do: Including in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. No Food-Monitoring: No recommendation for food records or logs during treatment. |
| Do, Accept, Motivation through Narratives, Check-Ins, Long-Term Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Do: Including in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. Food Monitoring - Long-Term: Use of food logs for duration of treatment. |
| Do, Change, Motivation Through Values, Sessions, Short-Term Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Do: Including in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment. |
| Do, Change, Motivation Through Values, Sessions, No Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Do: Including in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. No Food-Monitoring: No recommendation for food records or logs during treatment. |
| Do, Change, Motivation through Values, Check-Ins, Long-Term Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Do: Including in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. Food Monitoring - Long-Term: Use of food logs for duration of treatment. |
| Do, Change, Motivation Through Narratives, Sessions, Long-term Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Do: Including in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. Food Monitoring - Long-Term: Use of food logs for duration of treatment. |
| Talk, Accept, Motivation through Values, Sessions, Short-Term Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment. |
| Talk, Accept, Motivation through Values, Sessions, No Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. No Food-Monitoring: No recommendation for food records or logs during treatment. |
| Talk, Accept, Motivation through Narratives, Check-Ins, Short-Term Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment. |
| Talk, Accept, Motivation through Narratives, Check-Ins, No Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. No Food-Monitoring: No recommendation for food records or logs during treatment. |
| Talk, Change, Motivation Through Values, Sessions, Long-Term Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. Food Monitoring - Long-Term: Use of food logs for duration of treatment. |
| Talk, Change, Motivation Through Values, Sessions, No Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. No Food-Monitoring: No recommendation for food records or logs during treatment. |
| Talk, Change, Motivation through Values, Check-Ins, Short-Term Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment. |
| Talk, Change, Motivation through Values, Check-Ins, No Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. No Food-Monitoring: No recommendation for food records or logs during treatment. |
| Talk, Change, Motivation through Narratives, Sessions, Short-Term Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment. |
| Talk, Change, Motivation through Narratives, Sessions, No Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. No Food-Monitoring: No recommendation for food records or logs during treatment. |
| Talk, Change, Motivation through Narratives, Check-Ins, Long-Term Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. Food Monitoring - Long-Term: Use of food logs for duration of treatment. |
| Do, Change, Motivation through Narratives, Check-Ins, Short-Term Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Do: Including in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment. |
| Do, Change, Motivation through Narratives, Check-Ins, No Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Do: Including in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. No Food-Monitoring: No recommendation for food records or logs during treatment. |
| Talk, Accept, Motivation through Values, Check-Ins, Long-Term Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. Food Monitoring - Long-Term: Use of food logs for duration of treatment. |
| Talk, Accept, Motivation through Narratives, Sessions, Long-Term Food Logs | Experimental | Behavioral: Relapse Prevention and Changing Habits (REACH+)Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. Food Monitoring - Long-Term: Use of food logs for duration of treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of Anorexia Nervosa at hospital admission
- Medically Stable
- Internet capability with videoconferencing
- Weight restored (BMI > 19 kg/m2) at New York State Psychiatric Institute
Key exclusion criteria (6 listed)
- Current substance use or other comorbid disorder requiring specialized treatment
- Pregnancy
- Imminent risk of suicide
- Serious medical illness
- Daily psychotropic medication other than antidepressants (medications that are known effect weight are exclusionary, i.e. stimulants, olanzapine, mirtazapine)
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 |
|---|---|---|
| Relapse Prevention and Changing Habits (REACH+)Psychotherapy | Behavioural | Do, Accept, Motivation Through Values, Sessions, Long-Term Food Logs,, Do, Accept, Motivation through Narratives, Check-Ins, Long-Term Food Logs, Do, Accept, Motivation through Narratives, Sessions, No Food Logs, Do, Accept, Motivation through Narratives, Sessions, Short-Term Food Logs, Do, Accept, Motivation through Values, Check-Ins, No Food Logs, Do, Accept, Motivation through Values, Check-Ins, Short-Term Food Logs, Do, Accept, Motivation through Values, Sessions, Short-Term Food Logs, Do, Change, Motivation Through Narratives, Sessions, Long-term Food Logs, Do, Change, Motivation Through Values, Sessions, No Food Logs, Do, Change, Motivation Through Values, Sessions, Short-Term Food Logs, Do, Change, Motivation through Narratives, Check-Ins, No Food Logs, Do, Change, Motivation through Narratives, Check-Ins, Short-Term Food Logs, Do, Change, Motivation through Values, Check-Ins, Long-Term Food Logs, Talk, Accept, Motivation through Narratives, Check-Ins, No Food Logs, Talk, Accept, Motivation through Narratives, Check-Ins, Short-Term Food Logs, Talk, Accept, Motivation through Narratives, Sessions, Long-Term Food Logs, Talk, Accept, Motivation through Values, Check-Ins, Long-Term Food Logs, Talk, Accept, Motivation through Values, Sessions, No Food Logs, Talk, Accept, Motivation through Values, Sessions, Short-Term Food Logs, Talk, Change, Motivation Through Values, Sessions, Long-Term Food Logs, Talk, Change, Motivation Through Values, Sessions, No Food Logs, Talk, Change, Motivation through Narratives, Check-Ins, Long-Term Food Logs, Talk, Change, Motivation through Narratives, Sessions, No Food Logs, Talk, Change, Motivation through Narratives, Sessions, Short-Term Food Logs, Talk, Change, Motivation through Values, Check-Ins, No Food Logs, Talk, Change, Motivation through Values, Check-Ins, Short-Term Food Logs |
Primary outcome
Weight maintenance
Time frame: 6-month end of treatment
Measured via rate of weight loss (in lbs) following discharge from inpatient unit
5 secondary outcomes
Habit strength
Time frame: 6-month end of treatment
Weight/shape distortion
Time frame: 6-month end of treatment
Intrinsic motivation
Time frame: 6-month end of treatment
Dietary restriction
Time frame: 6-month end of treatment
Skill consolidation
Time frame: 6-month end of treatment
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 1 Jun 2026.
- Background: PubMed 35488866Steinglass JE, Attia E, Glasofer DR, Wang Y, Ruggiero J, Walsh BT, Thomas JG. Optimizing relapse prevention and changing habits (REACH+) in anorexia nervosa. Int J Eat Disord. 2022 Jun;55(6):851-857. doi: 10.1002/eat.23724. Epub 2022 Apr 30.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relapse Prevention and Changing Habits (REACH+) in people with Anorexia Nervosa, run by New York State Psychiatric Institute 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 1 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?
Contact Joanna Steinglass, MD (646-774-6345, js1124@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight maintenance (time frame: 6-month end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04810624, which also lists 1 linked publication.
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 1 Jun 2026.