Obesity
Conditions
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. 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.
Interventions
BEHAVIORALMindful 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.
Sponsors
Northeastern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | Primary endpoint: 8-weeks | Defined as achieving the target recruitment sample in a 12-month period, 80% retention, 70% attendance rate, and no serious adverse events. |
| Acceptability | Primary endpoint: 8-weeks | Defined as \>5/7 on acceptability questionnaire (1 = unacceptable, 7 = very acceptable) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNeha P Gothe, PhD, MA, MS
Northeastern University
Outcome results
None listed