RECRUITING

Investigating the Effects of the "GameDay Ready" Behavioral Weight Management Program for Black Men Living in the Rural South

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This pilot study investigates the effects of a newly developed 12-week weight management program called "GameDay Ready" (compared to a walking and general health education program) for decreasing body weight among Black men who live in the rural South. The researchers expect to see evidence of greater weight loss among participants randomized to receive the "GameDay Ready" program.

Official Title

Developing a Lifestyle Intervention to Reduce Body Weight for Obese African American Men Living in the Rural South

Quick Facts

Study Start:2023-08-04

Study Completion:2025-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05970042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 65 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Self-identified African American or Black American male * 25-65 years of age * BMI 27kg/m2 to ≤50kg/m2 (those with a BMI \>45 will need documented approval by a healthcare provider to participate in the study) * Live in a rural area of South Carolina and have lived in a rural area for at least 1 year * Able to speak and understand English * Willing to be randomized to the intervention or comparison program	* Positive response to any question on the Physical Activity Readiness Questionnaire (PAR-Q) (Participant may be included if approval is provided and documented by a healthcare provider) * Currently participating in another weight loss trial or program or have participated in a trial or program within 6 months prior to starting the intervention * Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg), diabetes, or asthma (Participant may be included if approval is provided and documented by a healthcare provider) * Pulmonary disease requiring supplemental oxygen or daily use of short-acting bronchodilators * Any musculoskeletal condition that would preclude meeting recommended levels of moderate-to- vigorous physical activity * Within 30 days prior to participating in the study, have taken prescription or nonprescription medications, herbals, or supplements for weight loss * On special diet for a serious health condition (does not include general dietary advice from a healthcare provider for common risk factors such as hypertension, diabetes, or hyperlipidemia). * Major surgery in the past 6 months * Have undergone weight loss surgery or considering weight loss surgery within the next 6 months * Have been treated for cancer in the past 12 months (other than non-melanoma skin cancer) * Weight loss ≥5% during the past 6 months * Plans to move to another county in the next 6 months * Any other perceived physical or mental health-related condition that would preclude participating in a behavioral program designed to promote weight loss

Inclusion Criteria

Exclusion Criteria

* Self-identified African American or Black American male
* 25-65 years of age
* BMI 27kg/m2 to ≤50kg/m2 (those with a BMI \>45 will need documented approval by a healthcare provider to participate in the study)
* Live in a rural area of South Carolina and have lived in a rural area for at least 1 year
* Able to speak and understand English
* Willing to be randomized to the intervention or comparison program

* Positive response to any question on the Physical Activity Readiness Questionnaire (PAR-Q) (Participant may be included if approval is provided and documented by a healthcare provider)
* Currently participating in another weight loss trial or program or have participated in a trial or program within 6 months prior to starting the intervention
* Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg), diabetes, or asthma (Participant may be included if approval is provided and documented by a healthcare provider)
* Pulmonary disease requiring supplemental oxygen or daily use of short-acting bronchodilators
* Any musculoskeletal condition that would preclude meeting recommended levels of moderate-to- vigorous physical activity
* Within 30 days prior to participating in the study, have taken prescription or nonprescription medications, herbals, or supplements for weight loss
* On special diet for a serious health condition (does not include general dietary advice from a healthcare provider for common risk factors such as hypertension, diabetes, or hyperlipidemia).
* Major surgery in the past 6 months
* Have undergone weight loss surgery or considering weight loss surgery within the next 6 months
* Have been treated for cancer in the past 12 months (other than non-melanoma skin cancer)
* Weight loss ≥5% during the past 6 months
* Plans to move to another county in the next 6 months
* Any other perceived physical or mental health-related condition that would preclude participating in a behavioral program designed to promote weight loss

Contacts and Locations

Study Contact

Demetrius A Abshire, PhD

CONTACT

803-576-6262

abshired@mailbox.sc.edu

Study Locations (Sites)

University of South Carolina

Columbia, South Carolina, 29208

United States

Collaborators and Investigators

Sponsor: University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-04

Study Completion Date2025-01

Study Record Updates

Study Start Date2023-08-04

Study Completion Date2025-01

Terms related to this study

Additional Relevant MeSH Terms

Obesity