Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07828717

Mindful Eating and Mindful Movement for Persons With Type 2 Diabetes Mellitus

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 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. 2. 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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Standard of Care Diet and Exercise Group

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. Mindfulness

    Time frame: Primary endpoint: 12-weeks

    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.

  2. Physical Activity Using Accelerometry

    Time frame: Primary endpoint: 12-weeks

    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.

  3. Dietary Habits

    Time frame: Primary endpoint: 12-weeks

    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.

  4. BMI

    Time frame: Primary endpoint: 12-weeks

    Height and weight will be measured using a stadiometer and calibrated digital scale, respectively to calculate BMI kg/m^2

  5. Hemoglobin A1c

    Time frame: Primary endpoint: 12-weeks

    Change in Hemoglobin A1c will be used as the biomarker for glycemic control.

  6. Cortisol

    Time frame: Primary endpoint: 12-weeks

    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.

  7. Medication Adherence

    Time frame: Primary endpoint: 12-weeks

    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.

  8. Medical History

    Time frame: Primary endpoint: 12-weeks

    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.

  9. Self-Efficacy

    Time frame: Primary endpoint: 12-weeks

    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.

  10. Subjective Physical Activity

    Time frame: Primary endpoint: 12-weeks

    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.

  11. Perceived Stress

    Time frame: Primary endpoint: 12-weeks

    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.

  12. Diabetes-Specific Stress

    Time frame: Primary endpoint: 12-weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Grace C Crozier, BA

CONTACT

[email protected]

717-449-4603

Neha P Gothe, MA, PhD

CONTACT

[email protected]

617-373-8848

Sponsors and collaborators

Lead sponsor

Northeastern University

Other

Registry information

Official study title

Mindful Eating and Mindful Movement for Persons With Type 2 Diabetes Mellitus: A Pilot Randomized Controlled Trial

Acronym: MEMO

Important dates

Study start
2027
Primary completion
2028
Study completion
2029
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.