NCT05791981

Brief Summary

To test a program that combines yoga and Christian spirituality (called Harmony \& Health) to learn if it can help participants exercise more.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

March 26, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

November 14, 2025

Status Verified

November 1, 2025

Enrollment Period

1.9 years

First QC Date

March 17, 2023

Last Update Submit

November 12, 2025

Conditions

PsychosocialMind-body

Outcome Measures

Primary Outcomes (1)

  • Fidelity of training and implementation across sites

    Fidelity will be achieved if there is ≥90% adherence to intervention delivery and receipt.

    6 months

Study Arms (2)

Harmony & Health Intervention (Group 1)

EXPERIMENTAL

Participants randomized to the Harmony and Health intervention group will attend group-based in-person intervention sessions at FOP or COGIC. on.

Behavioral: Harmony & Health InterventionDevice: Fitbit

Attention Control (Group 2)

EXPERIMENTAL

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).

Behavioral: Attention ControlDevice: Fitbit

Interventions

Harmony & Health InterventionBEHAVIORAL

Participants will attend group in person sessions 2 times each week for 8 weeks. The sessions will be 45 minutes long. In each session, there will be an introduction, 30 minutes of gentle yoga-based poses and breathing exercises, and then 10 minutes of guided relaxation and scripture meditation. Participants will be instructed to practice the exercises at home 2 times each week during the entire 6-month period. You will be given instructions and a yoga mat, belt, and block. After your Week 9 assessment, you will attend in-person or Zoom sessions 1 time each month over the final 4 months of the study

Harmony & Health Intervention (Group 1)
Attention ControlBEHAVIORAL

Participants will attend group in-person health education sessions 2 times each week for 8 weeks. The sessions will be 45 minutes long and will include discussions of disease prevention and other health and well-being topics. After your Week 9 assessment, you will have the ability to attend additional in-person or Zoom health education sessions 1 time each month over the final 4 months of the study.

Attention Control (Group 2)
FitbitDEVICE

Participants will be given a Fitbit and instructions on how to use it. The Fitbit will record your physical activity and report it to the study staff.

Attention Control (Group 2)Harmony & Health Intervention (Group 1)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women ≥18 years of age
  • Self-identify as Black or African American
  • Able to read, speak, and write in English
  • Self-report doing \<90 minutes/week of physical activity
  • Self-report sitting ≥6 hours/day
  • Body mass index \[BMI\] ≥25.0 kg/m2 based on self-reported height and weight
  • Able to provide informed consent
  • Able to pass the Physical Activity Readiness Questionnaire (PARQ) or provide physician's clearance to participate

You may not qualify if:

  • \<18 years of age
  • Does not identify as Black or African American
  • Unable or uncomfortable participating in English
  • Self-reports doing ≥90 minutes/week of physical activity
  • Self-reports sitting for \<6 hours/day
  • BMI \<25.0 kg/m2
  • Absolute contraindications to unassisted physical activity based on the PARQ (e.g., acute MI, orthopedic and musculoskeletal limitations)
  • Practicing yoga or enrolled in another program targeting physical activity, sitting time, or weight loss
  • Pregnant or planning to become pregnant during the 6 month study period
  • Planning to move from the Houston or Northeast Texas areas during the 6 month study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

Study Officials

  • Scherezade Mama, DRPH

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2023

First Posted

March 30, 2023

Study Start

March 26, 2024

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

November 14, 2025

Record last verified: 2025-11

Locations

US(1)