Obesity & OverweightNEW PATHNCT07363616
Pilot Test of Five Weight Neutral Interventions to Improve Health Among Adults of Higher Body Weight
A study testing Mediterranean eating style, Physical activity and Mindful Eating in people with Obesity & Overweight and Cardiometabolic Risk Factors, run by The Miriam Hospital at 1 site in United States.
Trial summary
The purpose of this research study is to pilot test five different, group based and remotely delivered programs designed to support healthy eating and regular physical activity. Each group will contain information and support for healthy eating and physical activity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight, Cardiometabolic Risk Factors
- What is being tested?
- Mediterranean eating style, Physical activity and Mindful Eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2025to 15 Nov 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older
- BMI between 25-40 (if BMI is between 25-30 then additional cardiometabolic risk factor must be present including hypertension, high cholesterol, prediabetes or type 2 diabetes)
Who cannot join
- current participation in a formal weight loss program
- current use of weight loss medication
- history of bariatric surgery
- physical condition that would limit the ability to engage in moderate intensity physical activity
- current pregnancy
- recent weight loss of 5% body weight
- condition that may interfere with ability to complete the study procedures
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
Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
KayLoni Olson, PhD, 401-793-8971, NEW_PATH@Brownhealth.org
About this study
Official title: Optimizing a Weight Neutral Intervention to Improve Health Among Adults of Higher Body Weight: A MOST Preparation Phase Study
The purpose of this research study is to pilot test five different, group based and remotely delivered programs designed to support healthy eating and regular physical activity. Each group will contain information and support for healthy eating and physical activity. Groups may also include support to 1) eat with more awareness of hunger and fullness, 2) improve how people think and feel about their bodies, and/or 3) identify ways to be physically active that are more enjoyable. Each group will include a unique combination of these components and the goal is to assess overall satisfaction and engagement with each of the programs.
Read the detailed description
The goal of study is to conduct a Multiphase Optimization STrategy (MOST) Preparation phase study to combine and pilot test candidate components for a group-based, remotely delivered weight neutral/healthy lifestyle intervention. Potential treatment components will include the following existing, evidence-based interventions; (1) mindfulness-based eating awareness training , (2) body acceptance program , and (3) a tailored intervention to promote enjoyment of physical activity. Weight neutral components will complement a Core intervention of standardized education on healthy diet (emphasizing the Mediterranean diet) and Physical Activity Guidelines for Americans (i.e., aerobic activity, muscle strengthening). This phase of the science is focused on pilot testing to ensure the target sample can be recruited and and that the novel combinations of treatment components can be delivered as intended. To make strategic use of resources, a fractional factorial design will be used to pilot test five conditions: the Core intervention alone and all possible combinations of the Core intervention + two or more of the weight neutral components. Men and women (n=50) with BMI≥25kg/m2 will be recruited and randomized in small groups (n=10) to receive one of the five conditions held online (each 12 weeks in duration).
- Conditions
- Obesity & Overweight, Cardiometabolic Risk Factors
- Being tested
- Mediterranean eating style, Physical activity, Mindful Eating, Body Appreciation, Enjoyable Exercise
- Keywords
- Mediterannean diet, Physical Activity, Weight Neutral, Lifestyle intervention, Mindful eating, Mindfulness-based Eating Awareness Training, Body Image, Obesity, Overweight, Cardiometabolic health, Multiphase Optimization STrategy (MOST), MOST Preparation Phase, Body appreciation
- Medical subject headings
- Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean eating styleBehavioural
The Mediterranean eating style is characterized by high intake of minimally processed, plant-based foods (fruits, vegetables, whole grains, beans and nuts), high intake of olive oil, moderate intake of dairy, low intake of red meat, and wine in moderation. This dietary pattern emphasizes inclusion of health promoting foods rather than focusing on restricting types and quantities of food, weight change is not a goal of this approach, and it is flexible rather than rule based to accommodate tastes/preferences. Daily self monitoring is a key strategy to support adherence to this eating style
Physical activityBehavioural
Based on the Physical Activity Guidelines for Americans (PAG) which provide a evidence-based summary of key recommendations for adults in the United States to achieve the robust health benefits accessible through regular physical activity. Recommendations include 150 minutes of moderate-to-vigorous aerobic exercise per week, muscle strengthening activities 2 times per week, and reducing daily sedentary time. Participants will receive psychoeducation and explore examples of activities that will help achieve the goal. Strategies for monitoring exercise will be reviewed.
Mindful EatingBehavioural
Based on Mindfulness-Based Eating Awareness Training (MB-EAT) which is a multi-session, group-based intervention designed to increase awareness of both internal and external cues to eat and to facilitate the capacity to regulate eating behaviors and food intake in response to these cues. These skills are developed through experiential activities that are completed in the group setting during each meeting including regular mindfulness practice and mindfulness activities specifically applied to the experience of eating. Participants are also given mindfulness activities to practice between group meetings.
Body AppreciationBehavioural
An adapted version of the Body Project, a dissonance-based body appreciation program designed to increase awareness of and actively challenge sociocultural factors that promote negative body image and can disrupt healthy eating and exercise. Participants engage in group discussion and experiential activities to practice resisting sources of pressure to conform to unhealthy body standards. Between-session activities help participants translate knowledge and skills to their daily lives.
Enjoyable ExerciseBehavioural
Participants will be provided with a brief overview and rationale for the importance of finding enjoyable ways to be physically active. Participants will experiment with different, evidence-based strategies to boost affect during exercise to build an activity routine that is enjoyable.
| Study group | Role | What they receive |
|---|---|---|
| Core Component | Experimental | Participants in the Core component condition will receive guidance and support for healthy eating and regular physical activity. Receives: Behavioral: Mediterranean eating style; Behavioral: Physical activity |
| Core Component+Mindful eating+Enjoyable exercise | Experimental | Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive support to eat with more awareness of hunger and fullness signals and to explore/identify ways to enjoy physical activity. Receives: Behavioral: Mediterranean eating style; Behavioral: Physical activity; Behavioral: Mindful Eating; Behavioral: Enjoyable Exercise |
| All component condition | Experimental | Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive support to eat with more awareness of hunger and fullness signals, strategies to improve how they think and feel about their bodies, and to explore/identify ways to enjoy physical activity. Receives: Behavioral: Mediterranean eating style; Behavioral: Physical activity; Behavioral: Mindful Eating; Behavioral: Body Appreciation; Behavioral: Enjoyable Exercise |
| Core Component+Mindful eating+Body Appreciation | Experimental | Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive support to eat with more awareness of hunger and fullness signals and strategies to improve how they think and feel about their bodies. Receives: Behavioral: Mediterranean eating style; Behavioral: Physical activity; Behavioral: Mindful Eating; Behavioral: Body Appreciation |
| Core component+body appreciation+enjoyment of exercise | Experimental | Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive strategies to improve how they think and feel about their bodies, and to explore/identify ways to enjoy physical activity. Receives: Behavioral: Mediterranean eating style; Behavioral: Physical activity; Behavioral: Body Appreciation; Behavioral: Enjoyable Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction Questionnaire
This 8-item self-report measure captures perceived quality and usefulness and overall satisfaction with treatment. Scores range from 8-32 with higher scores reflecting a more positive view of treatment.
Measured: End of treatment, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start31 Dec 2025
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363616
- Sponsor's protocol ID
- R03DK140291
- Other IDs
- R03DK140291
- Acronym
- NEW PATH
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified and scored data used to investigate the study aims will be preserved and shared upon approved request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing a Weight Neutral Intervention to Improve Health Among Adults of Higher Body Weight: A MOST Preparation Phase Study
- ClinicalTrials.gov ID
- NCT07363616
- Acronym / sponsor ID
- NEW PATH / R03DK140291
- Conditions
- Obesity & Overweight, Cardiometabolic Risk Factors
- Keywords
- Mediterannean diet, Physical Activity, Weight Neutral, Lifestyle intervention, Mindful eating, Mindfulness-based Eating Awareness Training, Body Image, Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 31 Dec 2025 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 23 Jan 2026 (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.
The purpose of this research study is to pilot test five different, group based and remotely delivered programs designed to support healthy eating and regular physical activity. Each group will contain information and support for healthy eating and physical activity. Groups may also include support to 1) eat with more awareness of hunger and fullness, 2) improve how people think and feel about their bodies, and/or 3) identify ways to be physically active that are more enjoyable. Each group will include a unique combination of these components and the goal is to assess overall satisfaction and engagement with each of the programs.
Detailed description
The goal of study is to conduct a Multiphase Optimization STrategy (MOST) Preparation phase study to combine and pilot test candidate components for a group-based, remotely delivered weight neutral/healthy lifestyle intervention. Potential treatment components will include the following existing, evidence-based interventions; (1) mindfulness-based eating awareness training , (2) body acceptance program , and (3) a tailored intervention to promote enjoyment of physical activity. Weight neutral components will complement a Core intervention of standardized education on healthy diet (emphasizing the Mediterranean diet) and Physical Activity Guidelines for Americans (i.e., aerobic activity, muscle strengthening). This phase of the science is focused on pilot testing to ensure the target sample can be recruited and and that the novel combinations of treatment components can be delivered as intended. To make strategic use of resources, a fractional factorial design will be used to pilot test five conditions: the Core intervention alone and all possible combinations of the Core intervention + two or more of the weight neutral components. Men and women (n=50) with BMI≥25kg/m2 will be recruited and randomized in small groups (n=10) to receive one of the five conditions held online (each 12 weeks in duration).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Core Component | Experimental | Behavioral: Mediterranean eating style, Behavioral: Physical activityParticipants in the Core component condition will receive guidance and support for healthy eating and regular physical activity. |
| Core Component+Mindful eating+Enjoyable exercise | Experimental | Behavioral: Mediterranean eating style, Behavioral: Physical activity, Behavioral: Mindful Eating, Behavioral: Enjoyable ExerciseParticipants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive support to eat with more awareness of hunger and fullness signals and to explore/identify ways to enjoy physical activity. |
| All component condition | Experimental | Behavioral: Mediterranean eating style, Behavioral: Physical activity, Behavioral: Mindful Eating, Behavioral: Body Appreciation, Behavioral: Enjoyable ExerciseParticipants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive support to eat with more awareness of hunger and fullness signals, strategies to improve how they think and feel about their bodies, and to explore/identify ways to enjoy physical activity. |
| Core Component+Mindful eating+Body Appreciation | Experimental | Behavioral: Mediterranean eating style, Behavioral: Physical activity, Behavioral: Mindful Eating, Behavioral: Body AppreciationParticipants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive support to eat with more awareness of hunger and fullness signals and strategies to improve how they think and feel about their bodies. |
| Core component+body appreciation+enjoyment of exercise | Experimental | Behavioral: Mediterranean eating style, Behavioral: Physical activity, Behavioral: Body Appreciation, Behavioral: Enjoyable ExerciseParticipants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive strategies to improve how they think and feel about their bodies, and to explore/identify ways to enjoy physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years and older
- BMI between 25-40 (if BMI is between 25-30 then additional cardiometabolic risk factor must be present including hypertension, high cholesterol, prediabetes or type 2 diabetes)
Key exclusion criteria (7 listed)
- current participation in a formal weight loss program
- current use of weight loss medication
- history of bariatric surgery
- physical condition that would limit the ability to engage in moderate intensity physical activity
- current pregnancy
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 |
|---|---|---|
| Mediterranean eating styleThe Mediterranean eating style is characterized by high intake of minimally processed, plant-based foods (fruits, vegetables, whole grains, beans and nuts), high intake of olive oil, moderate intake of dairy, low intake of red meat, and wine in moderation. This dietary pattern emphasizes inclusion of health promoting foods rather than focusing on restricting types and quantities of food, weight change is not a goal of this approach, and it is flexible rather than rule based to accommodate tastes/preferences. Daily self monitoring is a key strategy to support adherence to this eating style | Behavioural | All component condition, Core Component, Core Component+Mindful eating+Body Appreciation, Core Component+Mindful eating+Enjoyable exercise, Core component+body appreciation+enjoyment of exercise |
| Physical activityBased on the Physical Activity Guidelines for Americans (PAG) which provide a evidence-based summary of key recommendations for adults in the United States to achieve the robust health benefits accessible through regular physical activity. Recommendations include 150 minutes of moderate-to-vigorous aerobic exercise per week, muscle strengthening activities 2 times per week, and reducing daily sedentary time. Participants will receive psychoeducation and explore examples of activities that will help achieve the goal. Strategies for monitoring exercise will be reviewed. | Behavioural | All component condition, Core Component, Core Component+Mindful eating+Body Appreciation, Core Component+Mindful eating+Enjoyable exercise, Core component+body appreciation+enjoyment of exercise |
| Mindful EatingBased on Mindfulness-Based Eating Awareness Training (MB-EAT) which is a multi-session, group-based intervention designed to increase awareness of both internal and external cues to eat and to facilitate the capacity to regulate eating behaviors and food intake in response to these cues. These skills are developed through experiential activities that are completed in the group setting during each meeting including regular mindfulness practice and mindfulness activities specifically applied to the experience of eating. Participants are also given mindfulness activities to practice between group meetings. | Behavioural | All component condition, Core Component+Mindful eating+Body Appreciation, Core Component+Mindful eating+Enjoyable exercise |
| Body AppreciationAn adapted version of the Body Project, a dissonance-based body appreciation program designed to increase awareness of and actively challenge sociocultural factors that promote negative body image and can disrupt healthy eating and exercise. Participants engage in group discussion and experiential activities to practice resisting sources of pressure to conform to unhealthy body standards. Between-session activities help participants translate knowledge and skills to their daily lives. | Behavioural | All component condition, Core Component+Mindful eating+Body Appreciation, Core component+body appreciation+enjoyment of exercise |
| Enjoyable ExerciseParticipants will be provided with a brief overview and rationale for the importance of finding enjoyable ways to be physically active. Participants will experiment with different, evidence-based strategies to boost affect during exercise to build an activity routine that is enjoyable. | Behavioural | All component condition, Core Component+Mindful eating+Enjoyable exercise, Core component+body appreciation+enjoyment of exercise |
Primary outcome
Client Satisfaction Questionnaire
Time frame: End of treatment, 12 weeks
This 8-item self-report measure captures perceived quality and usefulness and overall satisfaction with treatment. Scores range from 8-32 with higher scores reflecting a more positive view 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 23 Jan 2026.
- Individual participant dataSharing planned: Yes. All de-identified and scored data used to investigate the study aims will be preserved and shared upon approved request.
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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 Mediterranean eating style, Physical activity and Mindful Eating in people with Obesity & Overweight and Cardiometabolic Risk Factors, run by The Miriam Hospital 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 2 inclusion and 7 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 23 Jan 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 KayLoni Olson, PhD (401-793-8971, kayloni.olson@brownhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client Satisfaction Questionnaire (time frame: End of treatment, 12 weeks). 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 23 Jan 2026.