Trial Outcomes & Findings for "GameDay Ready": Evaluating a Behavioral Weight Management Program for Black Men Living in the Rural South (NCT NCT05530980)
NCT ID: NCT05530980
Last Updated: 2024-02-02
Results Overview
Number of people expressing interest in the study
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
Up to week 1
Results posted on
2024-02-02
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
"GameDay Ready": Evaluating a Behavioral Weight Management Program for Black Men Living in the Rural South
Baseline characteristics by cohort
| Measure |
GameDay Ready Intervention
n=7 Participants
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.
|
|---|---|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to week 1Population: Overall number of participants analyzed represents number of participants screened for study interest prior to enrollment.
Number of people expressing interest in the study
Outcome measures
| Measure |
GameDay Ready Program
n=91 Participants
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.
GameDay Ready Program: 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.
|
|---|---|
|
Study Interest
|
91 Number of people
|
PRIMARY outcome
Timeframe: Up to week 1Number of men who express interest in the study and are eligible.
Outcome measures
| Measure |
GameDay Ready Program
n=91 Participants
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.
GameDay Ready Program: 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.
|
|---|---|
|
Eligibility
|
14 number of people
|
PRIMARY outcome
Timeframe: Up to week 1Population: Overall number of participants analyzed reflects the number of participants who enrolled in the study.
Length of time needed to enroll the desired sample size (length of time reflects when recruitment was initiated until study launch)
Outcome measures
| Measure |
GameDay Ready Program
n=7 Participants
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.
GameDay Ready Program: 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.
|
|---|---|
|
Time to Enroll
|
5 months
|
PRIMARY outcome
Timeframe: Baseline to 3 monthsPopulation: Of the 7 participants who were enrolled in the study, one did not attend any session. One enrolled participant only attended the first session.
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.
Outcome measures
| Measure |
GameDay Ready Program
n=12 Sessions
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.
GameDay Ready Program: 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.
|
|---|---|
|
Attendance
Percentage of sessions attended based on 7 enrolled participants.
|
49 percentage of sessions attended
|
|
Attendance
Percentage of sessions attended excluding one participant who attended 0 sessions.
|
57 percentage of sessions attended
|
|
Attendance
Percentage of sessions attended excluding participants who attended 0 or just 1 session.
|
67 percentage of sessions attended
|
PRIMARY outcome
Timeframe: Baseline to 3 and 6 monthsNumber and percentage of enrolled men who withdraw from the study
Outcome measures
| Measure |
GameDay Ready Program
n=7 Participants
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.
GameDay Ready Program: 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.
|
|---|---|
|
Attrition
Number of enrolled participants remaining in study at 3 months.
|
5 Participants
|
|
Attrition
Number of enrolled participants remaining in study at 6 months.
|
4 Participants
|
SECONDARY outcome
Timeframe: Change from baseline to 3 and 6 monthsParticipant body weight measured using a portable, professional-grade scale
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 3 and 6 monthsWeight in kilograms divided by height in meters squared
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 3 and 6 monthsMeasured using an anthropometric measuring tape
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 3 and 6 monthsSystolic and diastolic blood pressure measured using an a portable automatic monitor
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 3 and 6 monthsAverage minutes of moderate-to-vigorous physical activity measured over 7 consecutive days using an accelerometer
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 3 and 6 monthsCaloric intake, saturated fat intake, fruit and vegetable intake measured using 3-day 24 hour dietary recalls
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 3 and 6 monthsMeasured using validated scales developed by Sallis et al.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 3 and 6 monthsMeasured using the 33-item Rural Active Living Perceived Environmental Support Scale
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 3 and 6 monthsMeasured using an 8-item Weight Control Motivation Scale
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 3 and 6 monthsMeasured using a 15-item scale of the Treatment Self-Regulation Questionnaire
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 3 and 6 monthsMeasured using the 24-item Motivation for Exercise Scale
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 3 and 6 monthsMeasured using a 16-item Self-Efficacy for Exercise Scale
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 3 and 6 monthsMeasured using the neighborhood surroundings subscale of the Neighborhood Environment Walkability Scale
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 3 and 6 monthsMeasured using the neighborhood safety subscale of the Neighborhood Environment Walkability Scale
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 3 and 6 monthsMeasured using a 6-item scale developed by Wilson \& Bengoechea
Outcome measures
Outcome data not reported
Adverse Events
GameDay Ready Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Demetrius Abshire
University of South Carolina College of Nursing
Phone: 803-576-6262
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place