Diet, Healthy, Obesity, Physical Inactivity
Conditions
Brief summary
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.
Interventions
BEHAVIORALGameDay 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.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
25 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Self-identified African American or Black American male * BMI 27kg/m\^2 to 50kg/m\^2 (healthcare provider approval required for those with a BMI \>45) * Able to speak and understand English
Exclusion criteria
* 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 intervention, 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 surgery * Have been treated for cancer in the past 12 months (other than non-melanoma skin cancer) * Weight loss ≥5% during the past 6 months * Any other perceived physical or mental health-related condition that would preclude participating in a behavioral program designed to promote weight loss * Intending to move within 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Interest | Up to week 1 | Number of people expressing interest in the study |
| Eligibility | Up to week 1 | Number of men who express interest in the study and are eligible. |
| Time to Enroll | Up to week 1 | Length of time needed to enroll the desired sample size (length of time reflects when recruitment was initiated until study launch) |
| Attendance | Baseline to 3 months | 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. |
| Attrition | Baseline to 3 and 6 months | Number and percentage of enrolled men who withdraw from the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Blood Pressure | Change from baseline to 3 and 6 months | Systolic and diastolic blood pressure measured using an a portable automatic monitor |
| Change in Moderate-to-vigorous Physical Activity | Change from baseline to 3 and 6 months | Average minutes of moderate-to-vigorous physical activity measured over 7 consecutive days using an accelerometer |
| Dietary Intake | Change from baseline to 3 and 6 months | Caloric intake, saturated fat intake, fruit and vegetable intake measured using 3-day 24 hour dietary recalls |
| Motivation for Weight Loss | Change from baseline to 3 and 6 months | Measured using an 8-item Weight Control Motivation Scale |
| Motivation for Healthy Eating | Change from baseline to 3 and 6 months | Measured using a 15-item scale of the Treatment Self-Regulation Questionnaire |
| Social Support for Diet and Physical Activity | Change from baseline to 3 and 6 months | Measured using validated scales developed by Sallis et al. |
| Self-efficacy for Exercise | Change from baseline to 3 and 6 months | Measured using a 16-item Self-Efficacy for Exercise Scale |
| Neighborhood Surroundings | Change from baseline to 3 and 6 months | Measured using the neighborhood surroundings subscale of the Neighborhood Environment Walkability Scale |
| Neighborhood Safety | Change from baseline to 3 and 6 months | Measured using the neighborhood safety subscale of the Neighborhood Environment Walkability Scale |
| Relatedness to Others in Physical Activity | Change from baseline to 3 and 6 months | Measured using a 6-item scale developed by Wilson & Bengoechea |
| Motivation for Physical Activity | Change from baseline to 3 and 6 months | Measured using the 24-item Motivation for Exercise Scale |
| Environmental Support for Physical Activity | Change from baseline to 3 and 6 months | Measured using the 33-item Rural Active Living Perceived Environmental Support Scale |
| Change in Weight | Change from baseline to 3 and 6 months | Participant body weight measured using a portable, professional-grade scale |
| Change in Body Mass Index | Change from baseline to 3 and 6 months | Weight in kilograms divided by height in meters squared |
| Change in Waist Circumference | Change from baseline to 3 and 6 months | Measured using an anthropometric measuring tape |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | GameDay Ready Intervention |
|---|---|
| Age, Continuous | 36 years STANDARD_DEVIATION 8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
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.
Time frame: Baseline to 3 months
Population: Of the 7 participants who were enrolled in the study, one did not attend any session. One enrolled participant only attended the first session.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GameDay Ready Program | Attendance | Percentage of sessions attended based on 7 enrolled participants. | 49 percentage of sessions attended |
| GameDay Ready Program | Attendance | Percentage of sessions attended excluding one participant who attended 0 sessions. | 57 percentage of sessions attended |
| GameDay Ready Program | Attendance | Percentage of sessions attended excluding participants who attended 0 or just 1 session. | 67 percentage of sessions attended |
Primary
Attrition
Number and percentage of enrolled men who withdraw from the study
Time frame: Baseline to 3 and 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GameDay Ready Program | Attrition | Number of enrolled participants remaining in study at 3 months. | 5 Participants |
| GameDay Ready Program | Attrition | Number of enrolled participants remaining in study at 6 months. | 4 Participants |
Primary
Eligibility
Number of men who express interest in the study and are eligible.
Time frame: Up to week 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GameDay Ready Program | Eligibility | 14 number of people |
Primary
Study Interest
Number of people expressing interest in the study
Time frame: Up to week 1
Population: Overall number of participants analyzed represents number of participants screened for study interest prior to enrollment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GameDay Ready Program | Study Interest | 91 Number of people |
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)
Time frame: Up to week 1
Population: Overall number of participants analyzed reflects the number of participants who enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GameDay Ready Program | Time to Enroll | 5 months |
Secondary
Change in Blood Pressure
Systolic and diastolic blood pressure measured using an a portable automatic monitor
Time frame: Change from baseline to 3 and 6 months
Secondary
Change in Body Mass Index
Weight in kilograms divided by height in meters squared
Time frame: Change from baseline to 3 and 6 months
Secondary
Change in Moderate-to-vigorous Physical Activity
Average minutes of moderate-to-vigorous physical activity measured over 7 consecutive days using an accelerometer
Time frame: Change from baseline to 3 and 6 months
Secondary
Change in Waist Circumference
Measured using an anthropometric measuring tape
Time frame: Change from baseline to 3 and 6 months
Secondary
Change in Weight
Participant body weight measured using a portable, professional-grade scale
Time frame: Change from baseline to 3 and 6 months
Secondary
Dietary Intake
Caloric intake, saturated fat intake, fruit and vegetable intake measured using 3-day 24 hour dietary recalls
Time frame: Change from baseline to 3 and 6 months
Secondary
Environmental Support for Physical Activity
Measured using the 33-item Rural Active Living Perceived Environmental Support Scale
Time frame: Change from baseline to 3 and 6 months
Secondary
Motivation for Healthy Eating
Measured using a 15-item scale of the Treatment Self-Regulation Questionnaire
Time frame: Change from baseline to 3 and 6 months
Secondary
Motivation for Physical Activity
Measured using the 24-item Motivation for Exercise Scale
Time frame: Change from baseline to 3 and 6 months
Secondary
Motivation for Weight Loss
Measured using an 8-item Weight Control Motivation Scale
Time frame: Change from baseline to 3 and 6 months
Secondary
Neighborhood Safety
Measured using the neighborhood safety subscale of the Neighborhood Environment Walkability Scale
Time frame: Change from baseline to 3 and 6 months
Secondary
Neighborhood Surroundings
Measured using the neighborhood surroundings subscale of the Neighborhood Environment Walkability Scale
Time frame: Change from baseline to 3 and 6 months
Secondary
Relatedness to Others in Physical Activity
Measured using a 6-item scale developed by Wilson & Bengoechea
Time frame: Change from baseline to 3 and 6 months
Secondary
Self-efficacy for Exercise
Measured using a 16-item Self-Efficacy for Exercise Scale
Time frame: Change from baseline to 3 and 6 months
Secondary
Social Support for Diet and Physical Activity
Measured using validated scales developed by Sallis et al.
Time frame: Change from baseline to 3 and 6 months