Health TrialsbyHealthPanel

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

ConditionType 2 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorNortheastern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Standard of Care Diet and Exercise GroupExperimental treatment 1 intervention
Group B: Mindful Eating and Mindful Movement (MEMO) GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northeastern University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: