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

NCT07828717 | Not Yet Recruiting DMC

• 1 other identifier: IRB#25-08-43
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The proposed study is the first intervention of its kind and will add to the scientific literature in several important ways:

1. 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. 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Primary endpoint: 12-weeks

Secondary Outcomes (12)

• Mindfulness

  Primary endpoint: 12-weeks

• Physical Activity Using Accelerometry

  Primary endpoint: 12-weeks

• Dietary Habits

  Primary endpoint: 12-weeks

• BMI

  Primary endpoint: 12-weeks

• Hemoglobin A1c

  Primary endpoint: 12-weeks

Study Arms (2)

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.

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.

Behavioral: Mindful Eating and Mindful Movement (MEMO) Group

Interventions

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.

Standard of Care Diet and Exercise Group

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.

Mindful Eating and Mindful Movement (MEMO) Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northeastern University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Neha P Gothe, MA, PhD

  Northeastern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neha P Gothe, MA, PhD

CONTACT

617-373-8848; n.gothe@northeastern.edu

Grace C Crozier, BA

CONTACT

717-449-4603; g.crozier@northeastern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: September 18, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 18, 2026

Record last verified: 2026-08