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NCT Number: NCT05922943

Harmony & Health: A Culturally Adapted Mindbody Intervention to Reduce Sitting Time and Improve Psychosocial Wellbeing in Black Adults

This community-based study will assess the efficacy of a culturally adapted, yoga-based intervention to reduce sitting time, increase physical activity, and improve psychosocial wellbeing among insufficiently active Black adults in the Houston area.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

Primary Objectives:

--The primary aim of the proposed study is to determine the efficacy of HH in reducing sitting time and increasing physical activity in insufficiently active Black adults. Hypothesis: HH participants will spend less time sitting and more time moving at post-intervention (week 9) compared to participants in the attention control group.

Secondary Objectives:

The secondary aims of this proposed study are to:

  • Examine the effects of HH on psychosocial wellbeing and the association of psychosocial wellbeing with behavioral outcomes. Hypothesis: HH participants will report improved psychosocial wellbeing, including reduced stress, depressive symptoms, and negative affect and improved quality of life, which will in turn mediate intervention outcomes at post-intervention (week 9) and follow up (week 24).
  • Evaluate the long-term benefits of the HH intervention. Hypothesis: HH participants will spend less time sitting and more time moving at follow up (week 24) compared to participants in the attention control group.

An exploratory aim of the proposed study is to identify implementation facilitators and barriers using a mixed-methods approach. Implementation of HH will be evaluated using the Consolidated Framework for Implementation Research (CFIR) and the RE-AIM Framework. In-depth interviews with key informants combined with administrative and questionnaire data will be used to identify critical facilitators and barriers for implementing HH and to evaluate reach, implementation, adoption, and maintenance.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults ≥18 years old
  • Self-identify as Black or African American
  • Self-reports MVPA <150 minutes/week
  • Self-reports sedentary time ≥6 hours/ day
  • Body mass index [BMI] ≥25.0 kg/m2 based on self-reported height and weight (and verified at baseline)
  • Able to pass the modified Physical Activity Readiness Questionnaire (PAR-Q) or provide physician's clearance to participate
  • Willing to be randomized to intervention or control
  • Comfortable participating in group-based physical activity
  • Able to read, speak, and write in English
  • Able to provide written informed consent without assistance

Exclusion criteria

  • < 18 years old
  • Self-reports MVPA .150 minutes/week
  • Self-reports sedentary time <6 hours/day
  • Not classified as overweight or obese (BMI <25.0 kg/m2)
  • Absolute contraindications to unassisted physical activity (e.g. acute MI, orthopedic and musculoskeletal limitations)
  • Practicing yoga or enrolled in another program targeting physical activity, sedentary behavior, or weight loss in the last 6 months
  • Previously participated in Harmony & Health
  • Pregnant or planning to become pregnant in the next 6 months
  • Planning to move from the Houston area within the next 6 months

Treatment and study plan

Harmony & Health program

Behavioral

Harmony & Health program may help improve psychosocial wellbeing in participants and if improvements in physical activity and wellbeing can last after the program ends. Yoga combines gentle movements, breathing exercises, relaxation techniques, and meditation all tailored to the participant's needs.

Primary outcomes

  1. Quality of life questionnaires

    Time frame: through study completion; an average of 6 months

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • American Cancer Society (ACS)

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Jun 28, 2023
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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