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| ID | Type | Description | Link |
|---|---|---|---|
| K23MD013899 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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The primary objective of this study is to test the feasibility and acceptability of a 12-week behavioral weight management intervention adapted for Black men living in the rural South. The intervention is guided by Self-Determination Theory of Motivation, Social Cognitive Theory, and Ecological Systems Theory. Key aspects of the intervention include a football-themed curriculum, facilitator and peer concordance to the extent possible (ie., similarly aged Black men), an emphasis on male-specific health concerns, group-based competition at multiple levels of the intervention (e.g., during in-person physical activity sessions and for achieving behavioral goals), a limited educational component, and physical activity being a substantial component of meeting sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GameDay Ready Program | Experimental | The GameDay Ready Program is a 12-week, football-themed, behavioral weight management intervention that promotes gradual increases in physical activity, reductions in sedentary time, and improvements in dietary habits through education, self-monitoring of physical activity and diet, personalized goal setting, group-based competition, social support, identifying and overcoming barriers, and including physical activity as a substantial component of meeting sessions. The program is sensitive to unique cultural influences surrounding gender, race, and rurality; and issues related to motivation are threaded throughout the program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GameDay Ready Program | Behavioral | GameDay Ready is a 12-week, group-based behavioral weight management program in which participants will meet in-person once per week at a publicly accessible walking track. Each weekly session will be led by a trained facilitator and will include a brief educational component, participant updates on progress, group discussions about overcoming barriers, supervised competitive physical activities, and goal setting for the upcoming week. Educational content will be reinforced and social support will be provided during warmup and cool down walks. Participants will be asked to set behavioral goals toward increasing physical activity and improving dietary habits and will be provided resources to self-monitor their activity, dietary intake, and weight. |
| Measure | Description | Time Frame |
|---|---|---|
| Study Interest | Number of people expressing interest in the study | Up to week 1 |
| Eligibility | Number of men who express interest in the study and are eligible. | Up to week 1 |
| Time to Enroll | Length of time needed to enroll the desired sample size (length of time reflects when recruitment was initiated until study launch) | Up to week 1 |
| Attendance | Number and proportion of enrolled men who attend each intervention session and total number of sessions. Percentage of sessions attended calculated as the total number of sessions attended divided by total number of sessions offered. | Baseline to 3 months |
| Attrition | Number and percentage of enrolled men who withdraw from the study | Baseline to 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | Participant body weight measured using a portable, professional-grade scale | Change from baseline to 3 and 6 months |
| Change in Body Mass Index | Weight in kilograms divided by height in meters squared |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Demetrius A Abshire, PhD | University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Carolina | Columbia | South Carolina | 29208 | United States |
Data can be shared upon reasonable request.
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| ID | Title | Description |
|---|---|---|
| FG000 | GameDay Ready Intervention | The GameDay Ready Program is a 12-week, football-themed, behavioral weight management intervention that promotes gradual increases in physical activity, reductions in sedentary time, and improvements in dietary habits through education, self-monitoring of physical activity and diet, personalized goal setting, group-based competition, social support, identifying and overcoming barriers, and including physical activity as a substantial component of meeting sessions. The program is sensitive to unique cultural influences surrounding gender, race, and rurality; and issues related to motivation are threaded throughout the program. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GameDay Ready Intervention | The GameDay Ready Program is a 12-week, football-themed, behavioral weight management intervention that promotes gradual increases in physical activity, reductions in sedentary time, and improvements in dietary habits through education, self-monitoring of physical activity and diet, personalized goal setting, group-based competition, social support, identifying and overcoming barriers, and including physical activity as a substantial component of meeting sessions. The program is sensitive to unique cultural influences surrounding gender, race, and rurality; and issues related to motivation are threaded throughout the program. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Study Interest | Number of people expressing interest in the study | Overall number of participants analyzed represents number of participants screened for study interest prior to enrollment. | Posted | Number | Number of people | Up to week 1 |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GameDay Ready Intervention | The GameDay Ready Program is a 12-week, football-themed, behavioral weight management intervention that promotes gradual increases in physical activity, reductions in sedentary time, and improvements in dietary habits through education, self-monitoring of physical activity and diet, personalized goal setting, group-based competition, social support, identifying and overcoming barriers, and including physical activity as a substantial component of meeting sessions. The program is sensitive to unique cultural influences surrounding gender, race, and rurality; and issues related to motivation are threaded throughout the program. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Demetrius Abshire | University of South Carolina College of Nursing | 803-576-6262 | abshired@mailbox.sc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 19, 2023 | Dec 19, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 19, 2023 | Dec 19, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Change from baseline to 3 and 6 months |
| Change in Waist Circumference | Measured using an anthropometric measuring tape | Change from baseline to 3 and 6 months |
| Change in Blood Pressure | Systolic and diastolic blood pressure measured using an a portable automatic monitor | Change from baseline to 3 and 6 months |
| Change in Moderate-to-vigorous Physical Activity | Average minutes of moderate-to-vigorous physical activity measured over 7 consecutive days using an accelerometer | Change from baseline to 3 and 6 months |
| Dietary Intake | Caloric intake, saturated fat intake, fruit and vegetable intake measured using 3-day 24 hour dietary recalls | Change from baseline to 3 and 6 months |
| Social Support for Diet and Physical Activity | Measured using validated scales developed by Sallis et al. | Change from baseline to 3 and 6 months |
| Environmental Support for Physical Activity | Measured using the 33-item Rural Active Living Perceived Environmental Support Scale | Change from baseline to 3 and 6 months |
| Motivation for Weight Loss | Measured using an 8-item Weight Control Motivation Scale | Change from baseline to 3 and 6 months |
| Motivation for Healthy Eating | Measured using a 15-item scale of the Treatment Self-Regulation Questionnaire | Change from baseline to 3 and 6 months |
| Motivation for Physical Activity | Measured using the 24-item Motivation for Exercise Scale | Change from baseline to 3 and 6 months |
| Self-efficacy for Exercise | Measured using a 16-item Self-Efficacy for Exercise Scale | Change from baseline to 3 and 6 months |
| Neighborhood Surroundings | Measured using the neighborhood surroundings subscale of the Neighborhood Environment Walkability Scale | Change from baseline to 3 and 6 months |
| Neighborhood Safety | Measured using the neighborhood safety subscale of the Neighborhood Environment Walkability Scale | Change from baseline to 3 and 6 months |
| Relatedness to Others in Physical Activity | Measured using a 6-item scale developed by Wilson & Bengoechea | Change from baseline to 3 and 6 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Eligibility | Number of men who express interest in the study and are eligible. | Posted | Number | number of people | Up to week 1 |
|
|
|
| Primary | Time to Enroll | Length of time needed to enroll the desired sample size (length of time reflects when recruitment was initiated until study launch) | Overall number of participants analyzed reflects the number of participants who enrolled in the study. | Posted | Number | months | Up to week 1 |
|
|
|
| Primary | Attendance | Number and proportion of enrolled men who attend each intervention session and total number of sessions. Percentage of sessions attended calculated as the total number of sessions attended divided by total number of sessions offered. | Of the 7 participants who were enrolled in the study, one did not attend any session. One enrolled participant only attended the first session. | Posted | Number | percentage of sessions attended | Baseline to 3 months | Sessions | Sessions |
|
|
|
| Primary | Attrition | Number and percentage of enrolled men who withdraw from the study | Posted | Count of Participants | Participants | Baseline to 3 and 6 months |
|
|
|
| Secondary | Change in Weight | Participant body weight measured using a portable, professional-grade scale | Not Posted | Change from baseline to 3 and 6 months | Participants |
| Secondary | Change in Body Mass Index | Weight in kilograms divided by height in meters squared | Not Posted | Change from baseline to 3 and 6 months | Participants |
| Secondary | Change in Waist Circumference | Measured using an anthropometric measuring tape | Not Posted | Change from baseline to 3 and 6 months | Participants |
| Secondary | Change in Blood Pressure | Systolic and diastolic blood pressure measured using an a portable automatic monitor | Not Posted | Change from baseline to 3 and 6 months | Participants |
| Secondary | Change in Moderate-to-vigorous Physical Activity | Average minutes of moderate-to-vigorous physical activity measured over 7 consecutive days using an accelerometer | Not Posted | Change from baseline to 3 and 6 months | Participants |
| Secondary | Dietary Intake | Caloric intake, saturated fat intake, fruit and vegetable intake measured using 3-day 24 hour dietary recalls | Not Posted | Change from baseline to 3 and 6 months | Participants |
| Secondary | Social Support for Diet and Physical Activity | Measured using validated scales developed by Sallis et al. | Not Posted | Change from baseline to 3 and 6 months | Participants |
| Secondary | Environmental Support for Physical Activity | Measured using the 33-item Rural Active Living Perceived Environmental Support Scale | Not Posted | Change from baseline to 3 and 6 months | Participants |
| Secondary | Motivation for Weight Loss | Measured using an 8-item Weight Control Motivation Scale | Not Posted | Change from baseline to 3 and 6 months | Participants |
| Secondary | Motivation for Healthy Eating | Measured using a 15-item scale of the Treatment Self-Regulation Questionnaire | Not Posted | Change from baseline to 3 and 6 months | Participants |
| Secondary | Motivation for Physical Activity | Measured using the 24-item Motivation for Exercise Scale | Not Posted | Change from baseline to 3 and 6 months | Participants |
| Secondary | Self-efficacy for Exercise | Measured using a 16-item Self-Efficacy for Exercise Scale | Not Posted | Change from baseline to 3 and 6 months | Participants |
| Secondary | Neighborhood Surroundings | Measured using the neighborhood surroundings subscale of the Neighborhood Environment Walkability Scale | Not Posted | Change from baseline to 3 and 6 months | Participants |
| Secondary | Neighborhood Safety | Measured using the neighborhood safety subscale of the Neighborhood Environment Walkability Scale | Not Posted | Change from baseline to 3 and 6 months | Participants |
| Secondary | Relatedness to Others in Physical Activity | Measured using a 6-item scale developed by Wilson & Bengoechea | Not Posted | Change from baseline to 3 and 6 months | Participants |
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| Percentage of sessions attended excluding one participant who attended 0 sessions. |
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| Percentage of sessions attended excluding participants who attended 0 or just 1 session. |
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