Weight LossEMPWRNCT04847843
Eating Mindfully to Prevent Weight Regain
A study testing Mindfulness Orientated Recovery Enhancement in people with Weight Loss and Weight Gain, run by University of Utah at 1 site in United States.
Trial summary
The overall objective of this study is to evaluate the efficacy of a mindfulness-based intervention to prevent weight regain in weight-reduced adults. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Weight Gain, Eating Behavior
- What is being tested?
- Mindfulness Orientated Recovery Enhancement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2021to 22 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65
- Bariatric Surgery patients: 12-18 months post-operation.
- Medical weight loss patients: patients of the bariatric weight loss clinic, weight loss of 7% body mass via intentional weight loss within past 6 months; BMI >25 kg/m2 prior to intentional weight loss; stable for 3 months on medications.
- Lifestyle weight loss: weight loss of 7% body mass via intentional weight loss within past 6 months; BMI >25 kg/m2 prior to intentional weight loss.
Who cannot join
- Uncontrolled cardiovascular, metabolic, renal, or pulmonary disease; cancer treatment in past 5 years; untreated thyroid disease or other medical condition affecting weight or energy metabolism; severe food allergies; women who are pregnant, lactating, or planning pregnancy during participation in the trial; active psychiatric issues
- Additional criteria specific to patients with history of bariatric surgery: <12 months post-op; weight regain of >5% of body mass postoperation; history of admittance to rehabilitation facility; history of post-op complications that require recent inpatient management; patients who were required to stay in the hospital >1 week post-op; revision surgery patients; heart failure patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeting Maladaptive Eating Behaviors With Mindfulness-based Training to Prevent Weight Regain
The overall objective of this study is to evaluate the efficacy of a mindfulness-based intervention to prevent weight regain in weight-reduced adults.
Read the detailed description
Specific Aim 1: Determine the effect of MORE on weight loss maintenance.
Hypothesis:
MORE will result in less weight regain compared to CON after the 8-week intervention, and benefits will be sustained after 6-month of follow-up.
Specific Aim 2:
Determine the effect of MORE on reward-related behavioral processes (e.g., disinhibition, restraint, hedonic hunger).
Hypothesis:
MORE group will demonstrate changes in eating behaviors associated with preventing weight regain compared to CON immediately after MORE and after 6-months of follow-up.
- Conditions
- Weight Loss, Weight Gain, Eating Behavior, Obesity, Bariatric Surgery Candidate
- Being tested
- Mindfulness Orientated Recovery Enhancement, Control Intervention
- Keywords
- Appetite Regulation, Weight regain prevention, Weight loss maintenance, mindfulness, mindfulness orientated recovery enhancement
- Medical subject headings
- Weight Loss, Weight Gain, Feeding Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Orientated Recovery EnhancementBehavioural
Also called MORE
The MORE curriculum has been adapted for this intervention to address food intake behaviors and will provide training in mindfulness techniques to increase awareness of, and self-control over, cravings; reappraisal skills to promote emotion regulation and restructure motivations for highly palatable food intake; and savoring pleasant events and emotions to overcome defects in natural reward processing.
Control InterventionBehavioural
The curriculum will be based on the Diabetes Prevention Program's Prevent T2 for Life program, which is an evidence-based national healthful lifestyle maintenance intervention. This program includes training in healthful eating, meal planning, and recipe modification; time and stress management; adapting lifestyle habits for continued success during holidays, vacations, and other special situations; and relapse prevention.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Orientated Recovery Enhancement (MORE) Intervention | Experimental | 8-week MORE intervention adapted for preventing weight regain Receives: Behavioral: Mindfulness Orientated Recovery Enhancement |
| Control Intervention | Active comparator | 8-week control intervention based on the Diabetes Prevention Program's Prevent T2 for Life program. Receives: Behavioral: Control Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Body Weight
Body weight (kg) measured using a calibrated digital scale at three time points: baseline and 6 month follow up. Outcome measure was calculated by subtracting baseline weight from 6 month weigh. Lower value indicates greater weight loss.
Measured: Baseline and 6 month follow up
Secondary outcomes (5)
Ways of Savoring Checklist (WOSC).
Four questions from Bryant and Veroffs Ways of Savoring Checklist (WOSC) were used to assess momentary sensory-perceptual sharpening (ex 'I tried to intensify the moment by focusing on it') and intensifying positive emotional reactions to positive events as 'amplifying' savoring (ex. 'In the last week, I enjoyed the little things in life more fully'). The instrument uses a 5-point Likert scale (ranging from 0 = Strongly Disagree to 5 = Strongly Agree).
Scale Range: 4-20 Higher scores on the WOSC indicate a stronger perceived ability to savor positive experiences.
Measured: 6-month follow-up
Dietary Restraint
Participants completed the Three-Factor Eating Questionnaire (TFEQ) in a fasted state to measure dietary restraint (conscious restriction of food intake to prevent weight gain or to promote weight loss), disinhibition (tendency to eat opportunistically), and hunger. This questionnaire consists of 20 questions about restraint. Each item is scored either 0 or 1; therefore, the range is 0-20, with higher scores indicating greater levels of dietary restraint.
Measured: 6 month follow up
Dietary Disinhibition
Participants completed the Three-Factor Eating Questionnaire (TFEQ) in a fasted state to measure dietary restraint (conscious restriction of food intake to prevent weight gain or to promote weight loss), disinhibition (tendency to eat opportunistically), and hunger. This questionnaire consists of 16 items about disinhibition. Each item is scored either 0 or 1; therefore, the range is 0-16, with higher levels indicating greater levels of dietary disinhibition.
Measured: 6 month follow-up
Interoceptive Awareness
The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a self-report instrument utilizing a 6-point Likert scale (ranging from 0 = Never to 5 = Always).
Scale Range: 0-55 Higher scores on the MAIA indicate higher ability of interoceptive bodily awareness.
Measured: 6 month follow up
Hedonic Hunger
Participants completed the Three-Factor Eating Questionnaire (TFEQ) in a fasted state to measure dietary restraint (conscious restriction of food intake to prevent weight gain or to promote weight loss), disinhibition (tendency to eat opportunistically), and hunger. This questionnaire consists of 15 items about general levels of hunger. Each item is scored either 0 or 1; therefore, the range is 0-15, with higher scores indicating greater levels of hedonic hunger.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start16 Jun 2021
- Primary completion8 May 2023
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Weight LossStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Tanya Halliday, University of Utah
- Investigators
- Tanya Halliday, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847843
- Sponsor's protocol ID
- 0132961
- Other IDs
- KL2TR002539
- Acronym
- EMPWR
- Status last verified
- Nov 2025
- First submitted
- 13 Apr 2021
- Last updated
- 25 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Maladaptive Eating Behaviors With Mindfulness-based Training to Prevent Weight Regain
- ClinicalTrials.gov ID
- NCT04847843
- Acronym / sponsor ID
- EMPWR / 0132961
- Conditions
- Weight Loss, Weight Gain, Eating Behavior, Obesity, Bariatric Surgery Candidate
- Keywords
- Appetite Regulation, Weight regain prevention, Weight loss maintenance, mindfulness, mindfulness orientated recovery enhancement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Posted 25 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this study is to evaluate the efficacy of a mindfulness-based intervention to prevent weight regain in weight-reduced adults.
Detailed description
Specific Aim 1: Determine the effect of MORE on weight loss maintenance.
Hypothesis:
MORE will result in less weight regain compared to CON after the 8-week intervention, and benefits will be sustained after 6-month of follow-up.
Specific Aim 2:
Determine the effect of MORE on reward-related behavioral processes (e.g., disinhibition, restraint, hedonic hunger).
Hypothesis:
MORE group will demonstrate changes in eating behaviors associated with preventing weight regain compared to CON immediately after MORE and after 6-months of follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Orientated Recovery Enhancement (MORE) Intervention | Experimental | Behavioral: Mindfulness Orientated Recovery Enhancement8-week MORE intervention adapted for preventing weight regain |
| Control Intervention | Active comparator | Behavioral: Control Intervention8-week control intervention based on the Diabetes Prevention Program's Prevent T2 for Life program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65
- Bariatric Surgery patients: 12-18 months post-operation.
- Medical weight loss patients: patients of the bariatric weight loss clinic, weight loss of 7% body mass via intentional weight loss within past 6 months; BMI >25 kg/m2 prior to intentional weight loss; stable for 3 months on medications.
- Lifestyle weight loss: weight loss of 7% body mass via intentional weight loss within past 6 months; BMI >25 kg/m2 prior to intentional weight loss.
Key exclusion criteria (2 listed)
- Uncontrolled cardiovascular, metabolic, renal, or pulmonary disease; cancer treatment in past 5 years; untreated thyroid disease or other medical condition affecting weight or energy metabolism; severe food allergies; women who are pregnant, lactating, or planning pregnancy during participation in the trial; active psychiatric issues
- Additional criteria specific to patients with history of bariatric surgery: <12 months post-op; weight regain of >5% of body mass postoperation; history of admittance to rehabilitation facility; history of post-op complications that require recent inpatient management; patients who were required to stay in the hospital >1 week post-op; revision surgery patients; heart failure patients.
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 |
|---|---|---|
| Mindfulness Orientated Recovery EnhancementAlso: MOREThe MORE curriculum has been adapted for this intervention to address food intake behaviors and will provide training in mindfulness techniques to increase awareness of, and self-control over, cravings; reappraisal skills to promote emotion regulation and restructure motivations for highly palatable food intake; and savoring pleasant events and emotions to overcome defects in natural reward processing. | Behavioural | Mindfulness Orientated Recovery Enhancement (MORE) Intervention |
| Control InterventionThe curriculum will be based on the Diabetes Prevention Program's Prevent T2 for Life program, which is an evidence-based national healthful lifestyle maintenance intervention. This program includes training in healthful eating, meal planning, and recipe modification; time and stress management; adapting lifestyle habits for continued success during holidays, vacations, and other special situations; and relapse prevention. | Behavioural | Control Intervention |
Primary outcome
Changes in Body Weight
Time frame: Baseline and 6 month follow up
Body weight (kg) measured using a calibrated digital scale at three time points: baseline and 6 month follow up. Outcome measure was calculated by subtracting baseline weight from 6 month weigh. Lower value indicates greater weight loss.
5 secondary outcomes
Ways of Savoring Checklist (WOSC).
Time frame: 6-month follow-up
Dietary Restraint
Time frame: 6 month follow up
Dietary Disinhibition
Time frame: 6 month follow-up
Interoceptive Awareness
Time frame: 6 month follow up
Hedonic Hunger
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Tanya Halliday principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Orientated Recovery Enhancement in people with Weight Loss and Weight Gain, run by University of Utah 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 2 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: finished, as of the sponsor's last update on 25 Nov 2025. 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?
Yes. Results are posted in the registry (first posted 25 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Body Weight (time frame: Baseline and 6 month follow up). 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 25 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.