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

N/ANot Yet RecruitingNCT07828717

Northeastern University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Type 2 Diabetes

Interventions

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.