Developing a Lifestyle Intervention to Reduce Body Weight for Obese African American Men Living in the Rural South
Phase: NA
Conditions: Obesity, Physical Inactivity, Diet, Healthy
Sponsor: University of South Carolina

Oﬃcial Title: Developing a Lifestyle Interven3on to Reduce Body Weight for Obese African 
American Men Living in the Rural South 
NCT #: NCT05530980 
Date:  12/19/2023 
 
 
 

Protocol 
 
The primary objec3ve of this study to test the feasibility and acceptability of a theore3cally-
based 12-week behavioral weight management interven3on tailored to Black men living in the 
rural South. A total of 15 Black men living in Orangeburg County South Carolina or neighboring 
rural coun3es will be recruited. Primary outcomes of interest for this single group pretest-
posRest feasibility study include the number of Black men who express interest in the study, the 
number who are eligible/ineligible, the length of 3me needed to enroll the desired sample size, 
aRendance, and aRri3on. Change in weight and weight-related behaviors (physical ac3vity and 
dietary behaviors) will be secondary outcomes and will be measured at baseline and upon 
comple3ng the interven3on. Par3cipants who complete the interven3on will be invited to 
complete a post-interven3on focus group interview to provide feedback on the interven3on 
(e.g., mo3va3on for par3cipa3ng, program eﬀec3veness and enjoyment, facilitators and 
barriers to par3cipa3on, recommended improvements). This interview may be held virtually or 
in-person based on par3cipant preferences. The interview will be audio-recorded and 
transcribed by a professional transcrip3onist.  
 
Many par3cipants in the qualita3ve study that informed the development of the interven3on 
noted that safety and convenience were two important considera3ons in program planning. In 
addi3on, men noted a preference for programs that incorporated physical ac3vity during 
mee3ng sessions. Based on these considera3ons and the status of the COVID-19 pandemic at 
the 3me the interven3on was developed, publicly available walking track/outdoor areas were 
deemed to be a feasible and acceptable loca3on for interven3on delivery. In the event of 
inclement weather, mee3ng sessions will be held at a local YMCA.  
 
The table below shows a general overview for each of the core 12-week sessions. In brief, 
par3cipants will be taught core principles of weight loss and behavior change. Par3cipants will 
be provided with Fitbits and will be asked to self-monitor their physical ac3vity throughout the 
program. In addi3on, they will be asked to create Fitbit accounts and to support and compete 
with other men in the program. Par3cipants will also be asked to track their dietary intake using 
either paper-based tracking forms or a method of their choice (e.g., food tracking app such as 
MyFitnessPal). A simple kitchen scale will be provided to those needing one to facilitate 
accurate dietary tracking. Par3cipants will also be highly encouraged to monitor their weight 
throughout the program using a bathroom scale. A bathroom scale will be provided to those 
needing one. YMCA memberships will also be oﬀered for the dura3on of the study or ﬁnancial 
support to cover YMCA memberships will be provided to help par3cipants reach physical 
ac3vity goals. 
 
 
 
 
 
 
 

Sample Mee7ng Session 
Ac7vity 
Descrip7on 
Dura7on 
Welcome & educa3onal session 
Content addressed by facilitator; 
facilitated discussion of content 
10 minutes 
Progress reports & social support 
Par3cipants provide update on weekly 
progress (e.g., PA, diet, weight) 
10 minutes 
Warmup walk with socializa3on 
Timed walk around track, ﬁeld, or other 
PA des3na3on; opportunity for 
socializa3on with peers and facilitator 
10 minutes 
Compe33ve ac3vity 
Group-based compe33ve ac3vity 
(speciﬁc ac3vi3es to be planned with 
par3cipants but may include receiver 
drills, 40-yard dash, 2-hand touch 
football, pushups, etc.) 
15 minutes 
Cooldown walk with socializa3on 
Timed walk around track, ﬁeld, or other 
PA des3na3on; opportunity for 
socializa3on with peers and facilitator 
5 minutes 
Wrap-up and future planning 
Q/A session about content; next week 
goal secng 
10 minutes 
 
 
Surveys/Instruments 
 
Anthropometric measures (weight, body mass index, and waist circumference) will be measured 
during in-person visits at baseline, approximately 1 week ader comple3ng the interven3on, and 
approximately 3 months ader comple3ng the interven3on. Weight and height will be measured 
using a portable digital scale and stadiometer, and waist circumference will be measured using 
anthropometric measuring tape. Blood pressure will be measured in duplicate using a portable 
automa3c monitor. Moderate-vigorous physical ac3vity (MVPA) will be assessed using Ac3graph 
accelerometers worn on the wrist. Dietary intake will be assessed at each 3me point using three 
24-hour dietary recalls performed by the PI or research assistant using the Nutri3on Data 
System for Research sodware. Several psychosocial factors will be assessed. Social support for 
exercise will be assessed using a 13-item scale developed by Sallis and colleagues, and self-
eﬃcacy for exercise using a 16-item Self-Eﬃcacy for Exercise Ques3onnaire adapted from Garcia 
and King. Mo3va3on for healthy ea3ng will be assessed using 15 items of the Treatment Self-
Regula3on Ques3onnaire (TSRQ), and mo3va3on for physical ac3vity will be assessed using the 
24-item Mo3va3on for Exercise Scale. Mo3va3on for weight loss will be assessed using an 8-
item weight control mo3va3on scale developed by Stotland and colleagues. Environmental 
support for PA will be assessed using the 33-item Rural Ac3ve Living Perceived Environmental 
Support Scale (RALPESS). Subscales of the Neighborhood Environment Walkability Scale (NEWS) 
will be used to assess neighborhood surroundings and neighborhood safety. Relatedness to 
others in physical ac3vity will be assessed using a 6-item scale developed by Wilson & 
Bengoechea. A standard sociodemographic ques3onnaire will be used to assess various 
variables of interest including par3cipants’ age, living arrangements, educa3on, income, and 

insurance status. A generic medical history ques3onnaire will be used to assess various acute 
and/or chronic condi3ons that par3cipants may have.  
 
Upon comple3on of the 12-week program, an acceptability survey will be administered to 
par3cipants along with the other post-interven3on measures. A focus group interview will be 
held soon ader program comple3on for par3cipants to provide feedback on the interven3on 
(e.g., mo3va3on for par3cipa3ng, program eﬀec3veness and enjoyment, facilitators and 
barriers to par3cipa3on, recommended improvements).