Type 2 DiabetesMEMONCT07828717
Mindful Eating and Mindful Movement for Persons With Type 2 Diabetes Mellitus
A study testing Mindful Eating and Mindful Movement (MEMO) Group in people with Type 2 Diabetes, run by Northeastern University.
Trial summary
The proposed study is the first intervention of its kind and will add to the scientific literature in several important ways: 1. The novel integration of Mindful Eating and Mindful Movement for T2DM: The MEMO trial is the first randomized controlled trial to test the feasibility and acceptability of a combined mindful… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Mindful Eating and Mindful Movement (MEMO) Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2027to 1 Jan 2029
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 years of age at study enrollment T2DM diagnosis for at least 6 months Baseline assessment HgbA1c between 7-12% Baseline assessment BMI ≥ 27 Physician's consent to participate in exercise program, if necessary Ambulatory Absence of health conditions that may be exacerbated by exercise No bariatric surgery within the past 5 years or plans for bariatric surgery within the next 6 months (self-reported) No diagnosis of advanced kidney disease (eGFR < 30, self-reported) No current cancer treatment (surgery/chemotherapy/radiation) (self-reported) Not pregnant, lactating, or plans to become pregnant during the 6-month study period (self-reported) No participation in a structured weight loss or diabetes study in the past 12 months Intention to remain in the Boston metropolitan area over the duration of the study Good or corrected hearing and vision (self-reported) Ability to participate in English Access to Zoom on phone, tablet, or computer No plan of starting a GLP-1 over the next 12 weeks
Who cannot join
- Under 40 years of age Type 1 diabetes, gestational diabetes, or prediabetes diagnosis Baseline assessment HgbA1c < 7% or > 12% Baseline assessment BMI < 27 Non-consent of physician Non-ambulatory (e.g., use of walkers, wheelchairs) Presence of health conditions that may be exacerbated by exercise Bariatric surgery within the past 5 years or plans for bariatric surgery within the next 6 months Diagnosis of advanced kidney disease (eGFR < 30) Current cancer treatment (surgery/chemotherapy/radiation) (self-reported) Pregnant, lactating, or plans to become pregnant during the next 6 months Participation in a structured weight loss or diabetes study in the past 12 months Intent to move or take an extended vacation (> 2 weeks) during the first three months of the study period Problems with hearing or vision Inability to participate in English No access to Zoom on phone, tablet, or computer Started a GLP-1 in the past 3 months
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Mindful Eating and Mindful Movement for Persons With Type 2 Diabetes Mellitus: A Pilot Randomized Controlled Trial
The proposed study is the first intervention of its kind and will add to the scientific literature in several important ways:
- The novel integration of Mindful Eating and Mindful Movement for T2DM: The MEMO trial is the first randomized controlled trial to test the feasibility and acceptability of a combined mindful eating and yoga intervention specifically tailored to adults with T2DM. This study directly addresses the growing prevalence of T2DM and the limitations of current lifestyle recommendations, which often lack strategies that promote sustainable behavior change. By integrating two complementary mindfulness-based components, the MEMO trial aims to holistically address dietary habits, physical activity, and stress management, providing a model for transformative, patient-centered diabetes care.
- Exploring Mindfulness in Diet and Exercise as a Driver of Behavior Change: By incorporating mindfulness into both dietary and physical activity interventions, this study seeks to address the psychological and behavioral barriers that often hinder long-term diabetes management.
- Conditions
- Type 2 Diabetes
- Being tested
- Standard of Care Diet and Exercise Group, Mindful Eating and Mindful Movement (MEMO) Group
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care Diet and Exercise GroupBehavioural
Standard of Care Diet and Exercise Group: Supervised group sessions will be led by a registered dietitian once per week for 60 minutes over 12 weeks, offered in-person or virtually (Zoom) to increase program accessibility. Participants will be encouraged to participate in three 60-minute exercise sessions per week. Two live sessions per week will be led by a trained exercise specialist. Participants will be provided with a prerecorded video session to complete independently at their convenience.
Mindful Eating and Mindful Movement (MEMO) GroupBehavioural
Mindful Eating and Mindful Movement (MEMO) Group: Group mindful eating sessions will be led by a registered dietitian trained in mindful eating strategies. The group will meet once per week for 60 minutes over 12 weeks. Participants will be encouraged to participate in three 60-minute yoga sessions per week (two live sessions and one pre-recorded session to complete at home) over 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Diet and Exercise Group | Experimental | The standard of care diet program will provide participants with evidence-based dietary guidance aligned with current recommendations for T2DM and self-management tools, but no information regarding mindful eating or mindful meditation. Receives: Behavioral: Standard of Care Diet and Exercise Group |
| Mindful Eating and Mindful Movement (MEMO) Group | Experimental | The mindful eating component of the MEMO intervention will receive the same protocol as the standard of care group but will also have mindfulness practices interwoven into the program. Receives: Behavioral: Mindful Eating and Mindful Movement (MEMO) Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a combined mindful eating and yoga intervention
Defined as achieving the target recruitment sample in a 12-month period, 80% retention, 70% attendance rate, and no serious adverse events.
Measured: Primary endpoint: 12-weeks
Acceptability of a combined mindful eating and yoga intervention
Defined as >5/7 on acceptability questionnaire (1 = unacceptable, 7 = very acceptable).
Measured: Primary endpoint: 12-weeks
Secondary outcomes (12)
Mindfulness
The multidimensional construct of mindfulness will be measured using the Five Facet Mindfulness Questionnaire. The minimum value is 1, and the maximum value is 5. A higher score is better and reflects greater mindfulness.
Measured: Primary endpoint: 12-weeks
Physical Activity Using Accelerometry
Changes in physical activity levels will be measured objectively using accelerometers to capture the time (minutes) spent engaging in MVPA per day. The minimum amount of time is 0 minutes, and the maximum amount of time is 1440 minutes. Higher values are better.
Measured: Primary endpoint: 12-weeks
Dietary Habits
Dietary intake will be assessed using the Dutch Eating Behavior Questionnaire. The minimum value is 1, and the maximum value is 5. Higher values indicate greater endorsement of the eating behavior.
Measured: Primary endpoint: 12-weeks
BMI
Height and weight will be measured using a stadiometer and calibrated digital scale, respectively to calculate BMI kg/m^2
Measured: Primary endpoint: 12-weeks
Hemoglobin A1c
Change in Hemoglobin A1c will be used as the biomarker for glycemic control.
Measured: Primary endpoint: 12-weeks
Cortisol
Cortisol sampled from hair will be used as the biomarker for stress levels. The values are determined by the analyzer. Lower scores are better and reflect lower cortisol.
Measured: Primary endpoint: 12-weeks
Medication Adherence
The Adherence to Refills and Medication Scale for Diabetes (ARMS-D) will be used to measure diabetes medication adherence. The minimum value is 1, and the maximum value is 4. Lower scores are better.
Measured: Primary endpoint: 12-weeks
Medical History
Participants will complete a comprehensive medical history questionnaire to document changes in health status, including self-reported hypoglycemia as measured by the Clarke Hypoglycemia Awareness Survey. The minimum value is 0, and the maximum value is 7. A higher value is worse and reflects impaired hypoglycemia awareness.
Measured: Primary endpoint: 12-weeks
Self-Efficacy
The MEMO trial is grounded in Social Cognitive Theory, which highlights self-efficacy as a critical determinant of behavior change. Therefore, we will evaluate the impact of the intervention on participants' self-efficacy and confidence in managing T2DM using the Diabetes Management Self-Efficacy Scale. The minimum value is 1, and the maximum value is 5. Higher scores are better.
Measured: Primary endpoint: 12-weeks
Subjective Physical Activity
Changes in physical activity levels will be measured subjectively using the International Physical Activity Questionnaire. The minimum value is 0 MET-minutes/week, and the maximum value is 80,640 MET-minutes/week. Higher values are better.
Measured: Primary endpoint: 12-weeks
Perceived Stress
The Perceived Stress Scale will be used to capture broader stress levels, offering a reliable measure of participants' perceptions of general stress over the past month. The minimum value is 1, and the maximum value is 5. Lower scores are better.
Measured: Primary endpoint: 12-weeks
Diabetes-Specific Stress
The Diabetes Distress Scale will be used to measure diabetes-specific stressors in participant's lives. The minimum value is 1, and the maximum value is 6. A lower score is better.
Measured: Primary endpoint: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start1 Mar 2027 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neha P Gothe, MA, PhD, Principal investigator, Northeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828717
- Sponsor's protocol ID
- IRB#25-08-43
- Acronym
- MEMO
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Eating and Mindful Movement for Persons With Type 2 Diabetes Mellitus: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07828717
- Acronym / sponsor ID
- MEMO / IRB#25-08-43
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 18 Sep 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 proposed study is the first intervention of its kind and will add to the scientific literature in several important ways:
- The novel integration of Mindful Eating and Mindful Movement for T2DM: The MEMO trial is the first randomized controlled trial to test the feasibility and acceptability of a combined mindful eating and yoga intervention specifically tailored to adults with T2DM. This study directly addresses the growing prevalence of T2DM and the limitations of current lifestyle recommendations, which often lack strategies that promote sustainable behavior change. By integrating two complementary mindfulness-based components, the MEMO trial aims to holistically address dietary habits, physical activity, and stress management, providing a model for transformative, patient-centered diabetes care.
- Exploring Mindfulness in Diet and Exercise as a Driver of Behavior Change: By incorporating mindfulness into both dietary and physical activity interventions, this study seeks to address the psychological and behavioral barriers that often hinder long-term diabetes management.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Diet and Exercise Group | Experimental | Behavioral: Standard of Care Diet and Exercise GroupThe standard of care diet program will provide participants with evidence-based dietary guidance aligned with current recommendations for T2DM and self-management tools, but no information regarding mindful eating or mindful meditation. |
| Mindful Eating and Mindful Movement (MEMO) Group | Experimental | Behavioral: Mindful Eating and Mindful Movement (MEMO) GroupThe mindful eating component of the MEMO intervention will receive the same protocol as the standard of care group but will also have mindfulness practices interwoven into the program. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 40 years of age at study enrollment T2DM diagnosis for at least 6 months Baseline assessment HgbA1c between 7-12% Baseline assessment BMI ≥ 27 Physician's consent to participate in exercise program, if necessary Ambulatory Absence of health conditions that may be exacerbated by exercise No bariatric surgery within the past 5 years or plans for bariatric surgery within the next 6 months (self-reported) No diagnosis of advanced kidney disease (eGFR < 30, self-reported) No current cancer treatment (surgery/chemotherapy/radiation) (self-reported) Not pregnant, lactating, or plans to become pregnant during the 6-month study period (self-reported) No participation in a structured weight loss or diabetes study in the past 12 months Intention to remain in the Boston metropolitan area over the duration of the study Good or corrected hearing and vision (self-reported) Ability to participate in English Access to Zoom on phone, tablet, or computer No plan of starting a GLP-1 over the next 12 weeks
Key exclusion criteria (1 listed)
- Under 40 years of age Type 1 diabetes, gestational diabetes, or prediabetes diagnosis Baseline assessment HgbA1c < 7% or > 12% Baseline assessment BMI < 27 Non-consent of physician Non-ambulatory (e.g., use of walkers, wheelchairs) Presence of health conditions that may be exacerbated by exercise Bariatric surgery within the past 5 years or plans for bariatric surgery within the next 6 months Diagnosis of advanced kidney disease (eGFR < 30) Current cancer treatment (surgery/chemotherapy/radiation) (self-reported) Pregnant, lactating, or plans to become pregnant during the next 6 months Participation in a structured weight loss or diabetes study in the past 12 months Intent to move or take an extended vacation (> 2 weeks) during the first three months of the study period Problems with hearing or vision Inability to participate in English No access to Zoom on phone, tablet, or computer Started a GLP-1 in the past 3 months
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 |
|---|---|---|
| Standard of Care Diet and Exercise GroupStandard of Care Diet and Exercise Group: Supervised group sessions will be led by a registered dietitian once per week for 60 minutes over 12 weeks, offered in-person or virtually (Zoom) to increase program accessibility. Participants will be encouraged to participate in three 60-minute exercise sessions per week. Two live sessions per week will be led by a trained exercise specialist. Participants will be provided with a prerecorded video session to complete independently at their convenience. | Behavioural | Standard of Care Diet and Exercise Group |
| Mindful Eating and Mindful Movement (MEMO) GroupMindful Eating and Mindful Movement (MEMO) Group: Group mindful eating sessions will be led by a registered dietitian trained in mindful eating strategies. The group will meet once per week for 60 minutes over 12 weeks. Participants will be encouraged to participate in three 60-minute yoga sessions per week (two live sessions and one pre-recorded session to complete at home) over 12 weeks. | Behavioural | Mindful Eating and Mindful Movement (MEMO) Group |
Primary outcome
Feasibility of a combined mindful eating and yoga intervention
Time frame: Primary endpoint: 12-weeks
Defined as achieving the target recruitment sample in a 12-month period, 80% retention, 70% attendance rate, and no serious adverse events.
Acceptability of a combined mindful eating and yoga intervention
Time frame: Primary endpoint: 12-weeks
Defined as >5/7 on acceptability questionnaire (1 = unacceptable, 7 = very acceptable).
12 secondary outcomes
Mindfulness
Time frame: Primary endpoint: 12-weeks
Physical Activity Using Accelerometry
Time frame: Primary endpoint: 12-weeks
Dietary Habits
Time frame: Primary endpoint: 12-weeks
BMI
Time frame: Primary endpoint: 12-weeks
Hemoglobin A1c
Time frame: Primary endpoint: 12-weeks
Cortisol
Time frame: Primary endpoint: 12-weeks
Medication Adherence
Time frame: Primary endpoint: 12-weeks
Medical History
Time frame: Primary endpoint: 12-weeks
Self-Efficacy
Time frame: Primary endpoint: 12-weeks
Subjective Physical Activity
Time frame: Primary endpoint: 12-weeks
Perceived Stress
Time frame: Primary endpoint: 12-weeks
Diabetes-Specific Stress
Time frame: Primary endpoint: 12-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neha P Gothe, MA, PhD principal investigator
Northeastern University
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Eating and Mindful Movement (MEMO) Group in people with Type 2 Diabetes, run by Northeastern University.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Neha P Gothe, MA, PhD (617-373-8848, n.gothe@northeastern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a combined mindful eating and yoga intervention (time frame: Primary endpoint: 12-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.