The Mind-Body Project

NCT ID: NCT07139795

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-18

Study Completion Date

2026-08-31

Brief Summary

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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. What is the feasibility and acceptability of an 8-week mindful eating and yoga intervention for adults with overweight/obesity?
2. Does the program bring about changes in mindfulness, dietary behaviors, and physical activity?
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).

Researchers will compare the 8-week mindful eating and movement intervention to a waitlist control group.

Participants will:

Be assigned to the 8-week intervention or waitlist group. Participate 2x/week in the mindful eating and movement sessions. Complete assessments of feasibility and acceptability as well as self-report and objective assessments describe above.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention Group

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.

Group Type EXPERIMENTAL

Mindful eating and movement

Intervention Type 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.

Waitlist Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindful eating and movement

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 Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* \>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

Exclusion Criteria

* \< 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northeastern University

OTHER

Sponsor Role lead

Responsible Party

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Neha Gothe

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neha P Gothe, PhD, MA, MS

Role: PRINCIPAL_INVESTIGATOR

Northeastern University

Locations

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Northeastern University

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Neha P Gothe, PhD, MA, MS

Role: CONTACT

617-373-8848

Facility Contacts

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Neha P Gothe, MA, PhD

Role: primary

617-373-8848

Ethan Ouimet

Role: backup

716-475-0766

Other Identifiers

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IRB:25-06-24

Identifier Type: -

Identifier Source: org_study_id

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