The Mind-Body Project

NCT07139795 | Active Not Recruiting

• 1 other identifier: IRB:25-06-24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot clinical trial is to learn if a combined mindful eating and mindful movement (yoga) program is feasible and acceptable for people with overweight/obesity. The main questions it aims to answer are:

1. 1.What is the feasibility and acceptability of an 8-week mindful eating and yoga intervention for adults with overweight/obesity?
2. 2.Does the program bring about changes in mindfulness, dietary behaviors, and physical activity?
3. 3.Does the program lead to positive changes in body composition, and key biomarkers of blood sugar and lipids assessed via a blood panel using a finger stick procedure (no venous blood draw).

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Feasibility

  Defined as achieving the target recruitment sample in a 12-month period, 80% retention, 70% attendance rate, and no serious adverse events.

  Primary endpoint: 8-weeks

• Acceptability

  Defined as \>5/7 on acceptability questionnaire (1 = unacceptable, 7 = very acceptable)

  Primary endpoint: 8-weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants will engage in group mindful eating sessions 1x/week for 75 minutes. Participants will be encouraged to attend at least 2x/week, 45-minute yoga sessions.

Behavioral: Mindful eating and movement

Waitlist Control

NO INTERVENTION

Participants assigned to the waitlist control group will complete all baseline and follow-up assessments at the same time as the intervention group. They will receive the same 8-week program after the completion of all assessments by all participants.

Interventions

Mindful eating and movement BEHAVIORAL

Group mindful eating sessions will be conducted once per week, one hour per session, for eight weeks. Participants will be encouraged to attend at least two, 45-minute yoga sessions per week.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years of age
• Body Mass Index (BMI) \> 27 kg/m2
• Ambulatory
• Ability to read, write, and understand English
• Intention to remain in the Boston area for the duration of the study
• Good or corrected vision and hearing
• Not currently enrolled in a physical activity or nutrition study
• Affiliated with Northeastern as a student, faculty, staff, or alumni
• No participation in a weight loss study in the past 12 months
• Willingness to participate in all study measurements and activities of their assigned group
• Ability to provide informed consent
• No bariatric surgery in the past five years or plans for bariatric surgery within the study period

You may not qualify if:

• \< 18 years of age
• BMI \< 27 kg/m2
• Non-ambulatory (i.e., use of walkers, wheelchairs)
• Participation in a weight loss study in the past 12 months
• Currently enrolled in a different physical activity or nutrition study
• Significant problems with vision or hearing
• Unwilling to participate in all study measurements and/or activities of their assigned group
• Participation in guided yoga sessions in the past three months
• Adults not affiliated with Northeastern as a student, faculty, staff, or alumni
• Current cancer diagnosis and going through active treatment (chemotherapy, radiation)
• Pregnant, breastfeeding, or plans to become pregnant during the three-month intervention
• Inability to provide informed consent
• Bariatric surgery within the past five years or plans for bariatric surgery within the study period

Sponsors & Collaborators

• Northeastern University: lead

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Movement

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Neha P Gothe, PhD, MA, MS

  Northeastern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 24, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)