An interventional study of Standard of Care Diet and Exercise Group and Mindful Eating and Mindful Movement (MEMO) Group in Type 2 Diabetes, sponsored by Northeastern University. Not yet recruiting. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Northeastern University · Not applicable, Interventional, and Basic science
The proposed study is the first intervention of its kind and will add to the scientific literature in several important ways:
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Northeastern University is the lead sponsor of 55 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Under 40 years of age Type 1 diabetes, gestational diabetes, or prediabetes diagnosis Baseline assessment HgbA1c \< 7% or > 12% Baseline assessment \< 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 ( \< 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Standard of Care Diet and Exercise Group
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.
Behavioral: Mindful Eating and Mindful Movement (MEMO) Group
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) 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.
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.
Time frame: 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).
Time frame: Primary endpoint: 12-weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Primary endpoint: 12-weeks
Hemoglobin A1c
Change in Hemoglobin A1c will be used as the biomarker for glycemic control.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Primary endpoint: 12-weeks
No study locations are listed for this record.
Start is estimated for Mar 2027; primary completion for Jan 2028, 10 months later.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 10 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Northeastern University