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Mind-Body Intervention
Faith-based Mind-body Intervention for Psychosocial Health
N/A
Waitlist Available
Led By Scherezade Mama, DRPH
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial tests if a program combining yoga and Christian spirituality can help people exercise more.
Who is the study for?
This trial is for Black or African American adults who are over 18, have a BMI of at least 25, do less than 90 minutes of exercise per week, and sit for more than 6 hours a day. They must be able to consent, read, speak and write in English. Those who are pregnant or planning to move away from the study areas within six months cannot join.Check my eligibility
What is being tested?
The Harmony & Health program is being tested; it's a mix of yoga and Christian spirituality aimed at increasing physical activity among participants. The study will also use Fitbits to monitor activity levels compared with an attention control group.See study design
What are the potential side effects?
Since this intervention involves mind-body exercises like yoga, potential side effects may include muscle soreness or strain. However, these activities are generally considered safe when performed correctly.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fidelity of training and implementation across sites
Trial Design
2Treatment groups
Experimental Treatment
Group I: Harmony & Health Intervention (Group 1)Experimental Treatment2 Interventions
Participants randomized to the Harmony and Health intervention group will attend group-based in-person intervention sessions at FOP or COGIC. on.
Group II: Attention Control (Group 2)Experimental Treatment2 Interventions
Participants randomized to the attention control condition will participate in in-person group-based health education sessions twice a week for 8 weeks with a trained interventionist and will receive 4 monthly newsletters (20 total contacts).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fitbit
2021
N/A
~3560
Attention Control
2014
Completed Phase 2
~6520
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,369 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,750 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
833 Previous Clinical Trials
669,353 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I sit for less than 6 hours a day.I am under 18 years old.I am cleared by a doctor to engage in physical activities.I cannot do physical activities on my own due to health issues like a recent heart attack or bone/joint problems.I am not comfortable participating in English.I sit for 6 or more hours a day.I can understand and sign the consent form by myself.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Attention Control (Group 2)
- Group 2: Harmony & Health Intervention (Group 1)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies left to join this clinical trial?
"Unfortunately, this clinical trial is currently not recruiting patients. The trial was launched on July 31st 2023 and last modified on March 17th 2023; however, there are 1 other studies presently in need of participants."
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