A Hybrid Effectiveness-Implementation Study on Weight Gain Prevention Among 2-1-1 Callers
Phase: NA
Conditions: Weight Change, Body
Sponsor: Emory University

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A Hybrid Effectiveness-Implementation Study on Weight Gain Prevention among 2-1-1 Callers  
NCT04373434 
1.24.2024  
 

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A Hybrid Effectiveness-Implementation Study on Weight Gain Prevention among 2-1-1 Callers. 
 
 
Short Title: Core Research: HH/HF in 2-1-1 systems 
 
Principal Investigator: Michelle C. Kegler, MPH, DrPH 
 
Co-Investigators: Cam Escoffery, PhD, Regine Haardoerfer, PhD, David Howard, PhD, Terry Hartman, PhD, 
Alexandra Morshed, PhD. 
 
Sponsor: Centers for Disease Control and Prevention 
 
 
 
BACKGROUND & SIGNIFICANCE 
 
Importance of Weight Gain Prevention and Diet Quality in Cancer Prevention.  
It is now well-established that obesity and excess weight increase the risk of cancer (i.e., colorectal and post-
menopausal breast cancer), as well as other chronic diseases including diabetes, stroke, coronary heart 
disease, and arthritis.1-6 The World Cancer Research Fund and the American Institute for Cancer Research 
state “maintenance of a healthy weight throughout life may be one of the most important ways to protect 
against cancer” (p.8).7 Unfortunately, adults generally gain weight as they age.8-11 A prospective study of 
weight gain in over 120,000 adults reported an average increase of .8 pounds per year.12  
 
Weight gain prevention centers on balancing calories consumed with calories expended.13 Portion control and 
reduced consumption of sugar-sweetened beverages and fast food are integral to healthy eating patterns, as is 
increased consumption of fruits and vegetables.13 Estimates of the energy gap responsible for the current 
obesity problem range from 100 to 400 excess calories per day.13 Thus, relatively modest changes in daily 
caloric intake could help ameliorate the obesity epidemic. Despite this, a review of weight gain prevention 
interventions documents a dearth of rigorous community-based trials (most studies emphasize weight loss) 
and concludes there is an urgent need for such research.10  
 
Food choices that align with the US Dietary Guidelines for Americans are associated with better diet quality 
and can facilitate weight control. The Healthy Eating Index, (HEI) is a scoring metric that can be used to 
assess overall diet quality in relation to adherence with the Dietary Guidelines.14 We previously reported that 
better diet quality as measured by the HEI was associated with lower weight in a racially diverse (39% African 
American) population of community-dwelling adults.15 In other research, in a phone and mail-based 
intervention, diet quality was associated with modest weight loss at one year of follow-up (~ -1 unit BMI). 
Importantly, intervention-associated improvements in diet quality contributed to sustained weight management 
over two years. Compared to baseline, after two years of follow-up HEI diet quality scores continued to be 
significantly improved (+6.6) and contributed to sustained improvements in BMI.16     
 
Rationale for Intervening through Home Food Environments.  
Ecologic models of healthy eating and weight gain prevention acknowledge that influences at multiple levels 
(e.g., individual, interpersonal, organizational, community and policy) synergistically shape behavior.17-19  
These models highlight behavioral settings, such as homes and worksites.20-22 We believe the home is an 
especially important setting given that 68.4% of calories still come from foods prepared at home.23 Research 
shows that food availability in the home is associated with dietary quality and/or weight;24-32 as are food 
shopping and food preparation, family meals, serving of non-home food sources (e.g., fast food) and eating 
while watching TV.27,33-39 Social aspects of the home food environment are also influential. Family support can 
increase healthy eating, but family food preferences can do the opposite.31,40,41 Despite its important role in 
weight-related behaviors, few interventions have focused on the home environment and the Emory Prevention 
Research Center (EPRC) has developed one of the only home environment interventions to focus on weight 
gain prevention in adults.42,43 An intervention focused on the more proximal environment of the home, if 

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scalable, has the potential to be impactful as a stand-alone intervention, but also as one component of a multi-
level approach to combatting the obesity epidemic. 
  
Relevant Prior Work: Healthy Homes/Healthy Families Intervention (HH/HF)  
After a series of qualitative and quantitative studies to understand how home, faith and work settings 
influenced healthy eating, physical activity and tobacco use conducted from 2004 to 2010,32,44-50 the EPRC 
Community Advisory Board (CAB) prioritized obesity prevention through home environments as the focus of 
our intervention research.  Using Community Based Participatory Research (CBPR) in collaboration with our 
CAB in SW GA, we developed and tested the HH/HF intervention, which was originally delivered through home 
visits and telephone calls. The intervention involves a tailored home environment profile and a health coach 
working with participants 
to select and implement a 
series of healthy actions 
to create a home 
environment more 
supportive of healthy 
eating and physical 
activity (see Table 1).  
Healthy actions were 
selected based on an 
extensive review of the literature to identify features of the home associated with dietary behavior and/or 
weight-related outcomes. 
 
Feasibility/Acceptability Study. We collaboratively designed an intervention and pilot tested it in three 
counties in SW GA.51  The intervention was delivered by local staff, managed by Horizons Community 
Solutions.  The study was quasi-experimental in design with 90 households completing data collection at 
baseline, two and four months.  Participants in two counties were in the intervention group and participants in a 
third county were in the comparison group.  The intervention was six weeks, with two home visits and two 
phone calls.  The intervention resulted in numerous changes to the home environment among intervention 
group participants relative to comparison group participants.  Those in the intervention group improved their 
home food inventory, purchased fruits and vegetables more often, improved meal preparation methods, 
decreased meals with the TV on, and increased family support for healthy eating. Although not powered to 
detect dietary outcomes, we observed a significant decrease in percent energy intake from fat, and positive 
trends for fruit and vegetable consumption and weight.  While we saw changes in the home activity 
environment, there were no changes in level of moderate/vigorous physical activity. Focus groups with 
participants after the intervention suggested they would like a longer intervention; participants commented they 
were just starting to make changes when the intervention ended. 
 
Efficacy Trial. Given positive results in changing the home environment and promising trends for the weight-
related behaviors, we modified the intervention through a series of CAB work group meetings to refine and 
expand the list of healthy actions, and then conducted a RCT in collaboration with our CAB and three Federally 
Qualified Health Centers (FQHC) in SW GA.  As in the pilot, baseline data were used to generate a tailored 
home environment profile showing areas in need of improvement (e.g., too many high fat/salty snacks) and 
positive aspects of the home environment (e.g., family never eats in front of the TV). Coaches, again hired and 
supervised by Horizons, used the home environment profile to guide participants in choosing six healthy 
actions over the course of the intervention (three related to the food environment and three focused on the 
activity environment). The chosen healthy actions were recorded on a family contract which was signed by the 
participant and coach. Based on the healthy actions chosen, participants received supportive materials via mail 
(e.g., portion size plate) and tips for implementation and overcoming challenges from the coach. The 
intervention was delivered through three home visits and four coaching calls over 16 weeks. Control 
participants received three mailings of educational material at six week intervals. The intervention was 
delivered by health coaches who resided in SW GA and had at least a high school education, and experience 
in social or customer service. 
 
 
 
Table 1.  Sample of Healthy Actions for HH/HF intervention 
Healthy Eating Actions 
Always have a low calorie beverage available instead of sugar soda and/or sweet tea. 
Identify one unhealthy food or drink and do not allow it in the home. 
Bring home fresh vegetables and fruits at least once a week and make them easy to see and grab. 
Establish rules that limit eating while watching TV. 
Healthy Physical Activity Actions 
Keep at least one piece of exercise equipment or aid in a visible location and commit to using it 
once a week. 
Identify and commit to walking to a place in your neighborhood at least once a week. 
Establish a rule for screen free hours/days and use the time for exercise. 

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Providers from three FQHCs referred overweight and obese female patients to the study. Eligible participants 
were women, ages 35 to 65, lived with at least one other person, and lived no further than thirty miles from the 
referring clinic to facilitate home visits. Data collection was fairly extensive; study participants were asked to 
complete three baseline and two six and 12 month follow-up telephone interviews each, and wear an 
accelerometer at baseline and at six months follow-up. Of the 349 randomized into intervention or control, 
82.5% completed six month data collection and 76.8% completed 12 month data collection. At baseline, six 
months and 12 months, participants completed two 24 hour dietary recalls (one weekday and one  
weekend day).52 Dietary data were collected and analyzed using Nutrition Data System for Research (NDSR) 
software version 2010.53-55 Physical activity was measured using the 7-day Physical Activity Recall (PAR)56 and 
through accelerometers worn for seven days (ActiGraph 3X+) at baseline and six months post-baseline.  
 
 
In terms of primary outcomes, we documented sustained reductions in caloric intake among intervention 
participants relative to control participants over a 12-month period, as well as sustained improvements in 
dietary quality as measured by the HEI and numerous positive changes to the home food environment.  Daily 
energy intake decreased significantly more for the intervention than control group at six months (-274 Kcal 
versus -69 Kcal) and twelve months (-195 Kcal versus -76 Kcal), and was significant in longitudinal intent to 
treat analyses (p=.03). In terms 
of diet quality, the HEI score 
increased significantly more for 
participants in the intervention 
group compared to those in the 
control group at six months and 
was significantly different in 
longitudinal intent to treat 
analyses (p = .02). Although 
assessed through self-report 
with a relatively short timeframe 
for weight gain prevention, at 12 
months post-baseline, 82.6% of 
intervention participants had not 
gained weight compared to 
71.4% of control participants (p = .03). No change was observed for either objective or self-reported physical 
activity, although we again documented some changes to the home activity environment. Table 2 shows 
significant home food environment outcomes that correspond to the healthy actions promoted by HH/HF. The 
outcome results were published in the American Journal of Public Health.42  
 
Adaptation for 2-1-1 Delivery and Feasibility/Acceptability Study (IRB #86129 & #92840). With scalability 
in mind, we next obtained funding from NCI to adapt the intervention for telephone delivery with 2-1-1 callers.  
Given successful history with 2-1-1 in our smoke-free home research which involved telephone delivery and 
mailed materials, we partnered with United Way of Greater Atlanta 2-1-1 for this adaptation pilot study from 
2016 to 2018.  We formed a Steering Committee to help adapt the intervention for urban households living in 
disadvantaged neighborhoods within the metro area.   
 
In this recently completed one-arm study, we learned that telephone delivery is feasible, with comparable 
results in terms of changes in the home food environment and changes in the expected direction for eating and 
weight-related outcomes.  Atlanta 2-1-1 introduced the study to callers and conducted a brief eligibility 
screener.  If callers were interested in learning more, 2-1-1 line agents took their contact information and 
provided names and contact information to the EPRC via a secure website.  Over a 3 month period, they 
provided 265 names.  EPRC staff then screened, consented, enrolled, and collected baseline data on 101 of 
the 2-1-1 callers.  Eligibility criteria were broad to make it easy for 2-1-1 to identify interested callers and 
because of the focus on healthy eating and weight gain prevention which applies to almost everyone.  Core 
components of the HH/HF intervention remained the same as in the larger trial, but delivery took place over 
three months instead of five, and was reduced to six phone calls (no home visits) delivered at two week 
intervals over three months, with text messages tailored to barriers mentioned on the calls delivered on the off-
Table 2. HH/HF RCT Results for Home Food Environment Outcomes 
 
Home Food Environment Outcome 
Change from 
BL to Six 
Month F-UP 
Intent to treat 
analyses (Baseline 
to 12 Month F-UP)+ 
Unhealthy drinks in the home 
X 
X 
Unhealthy snacks in the home 
X 
X 
Frequency of fruit shopping 
- 
X 
Frequency of vegetable shopping 
- 
X 
Family eating in front of TV 
X 
X 
Healthy food preparation 
X 
X 
Healthy food serving practices 
X 
X 
Family meals from non-home sources 
X 
X 
Family support for healthy eating 
X 
- 
Telling others your weight 
- 
- 
x-SIGNIFICANT CHANGE IN DESIRED DIRECTION at p<.05. p-values for change between two time 
points results from independent t-tests and regression analyses; p-values for the ITT analysis are from growth 
modeling and refer to the significance of the interaction term of group and time 

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weeks.  We did not include the physical activity actions given null results in both the earlier pilot and the main 
trial. 
 
The majority of participants were African American (82%) and female (74%), with more men participating than 
expected.  Close to half of the participants were unemployed (48%), and just 14% were college graduates with 
10% not finishing high school.  All participants reported annual household incomes < $25,000.  Typical 
household size was 2.8 members, and less than half had children in the household (45%).  The mean age was 
44, and 44% received SNAP benefits. Of the 101 completing baseline data collection, 75% completed the first 
coaching call, and 51% completed at least four of the six calls.  Sixty percent were reached for follow-up one 
month post-intervention.  Outcome measures consisted of the home environment survey used in our prior 
studies and two 24 hour dietary recalls at baseline and four months.   Although not powered to detect change, 
we observed a significant increase in HEI scores14,57 (from 54.5 to 58.9), decreases in Kcal of 203 per day from 
pre to post, and decreases in self-reported weight of 4 pounds.  Consistent with one or both prior evaluations 
of the HH/HF intervention, we documented significant changes in household food inventories, food shopping 
behavior, food preparation, family meals from non-home sources (e.g., not eating out or getting take out), and 
less eating with the TV on.  Moderator analyses did not justify targeting the intervention to a specific 
subpopulation of callers. These results, which documented the feasibility of partnering with 2-1-1 to identify 
low-income individuals interested in a healthy eating/weight gain prevention intervention, combined with the 
potential reach of 2-1-1, position us for the current research project. 
 
Potential Reach of Regional 2-1-1 Infrastructure. In Georgia, the 2-1-1 infrastructure consists of nine United 
Way agencies.  United Way of Greater Atlanta 2-1-1 is the largest by far and is the first 2-1-1 in the U.S. and is 
today one of the busiest in the country. In 2017, they received close to 500 contacts per day (167,434 total).  
They cover the Atlanta metro area and also have contractual arrangements with several other 2-1-1s in the 
state to take their calls as the Atlanta 2-1-1 is staffed 24/7.  United Way of Central Georgia and United Way of 
the Chattahoochee Valley 2-1-1s cover much of the west central region of GA and have arrangements with 
Atlanta 2-1-1 for call coverage.  Macon 2-1-1 had 5,137 contacts in 2017 and Columbus 2-1-1 had 10,330.  
United Way of Albany 2-1-1 is a stand-alone 2-1-1 and takes calls from 12 counties in SW GA.  They received 
2,285 contacts in 2017.  All four of these 2-1-1s will participate in the effectiveness-implementation study 
with United Way of Greater Atlanta 2-1-1 (UWGA 2-1-1) serving as the main recruitment site. 
 
GOALS/AIMS 
 
We plan to conduct a hybrid-implementation effectiveness trial to evaluate a weight gain prevention 
intervention for delivery through 2-1-1s. Our specific aims for the research project are: 
 
Aim 1. Conduct a hybrid effectiveness implementation trial to assess the impact of a telephone-based 
home food environment intervention on weight-related dietary behaviors among 2-1-1 callers. 
Aim 2. Assess implementation and scale-up feasibility of an intervention delivery model to reach low 
income populations through a regional 2-1-1 system. 
Aim 3. Conduct a cost-effectiveness analysis of delivering a weight gain prevention intervention to 2-1-
1 callers through a regional 2-1-1 infrastructure. 
 
This IRB protocol focuses on Aim 1 – the hybrid effectiveness implementation trial, Aim 2 – assessing 
implementation and scale up feasibility of an intervention; and Aim 3, cost-effectiveness analysis of 
delivering the intervention. 
 
STUDY DESIGN 
 
EPRC Research Team  
The research team will be led by Dr. Michelle Kegler. Co-investigators include: Drs. Cam Escoffery, Regine 
Haardörfer, David Howard, Terry Hartman, and Alexandra Morshed. Day-to-day oversight of the project and 
data collection will be managed by Lucja Bundy. Shade Owolabi will serve as the intervention coordinator to 
supervise intervention delivery on the project.  
 

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Primary Organizational Partners  
Horizons Community Solutions, based in Albany, GA, will be a primary partner in the proposed research.  In 
addition, we will partner with four United Way 2-1-1 organizations (United Way of Greater Atlanta 2-1-1 (UWGA 
2-1-1), United Way of Central Georgia 2-1-1, Chattahoochee Valley 2-1-1 in Columbus, and United Way of 
Southwest Georgia (SWGA)). This research is funded by the Centers for Disease Control and Prevention. A 
subcontract with Horizons Community Solutions and two fee-for-service agreements with UWGA 2-1-1 and 
United Way of SWGA have been established. 
 
Setting and Location 
Study procedures, including informed consent and data collection, will be done over the telephone from the 
offices of the Rollins School of Public Health, Emory University, or home offices (due to COVID-19, CITI 
certified staff have been approved to carry out research activities at home). Recruitment and preliminary 
screening will occur at UWGA 2-1-1 and United Way of SWGA. Day-to-day operations of the project and 
oversight of data collection will be conducted by a Sr. Associate Director of Research Programs with support 
from staff and graduate research assistants. The intervention will be delivered jointly by Emory and Horizons 
staff. Process evaluation interviews with 2-1-1 leaders and staff and intervention arm participants will be 
conducted by Horizons staff and Emory staff and students. 
Population 
The study population will consist of 2-1-1 clients/callers. To be eligible for participation in the hybrid-
effectiveness implementation trial (aim 1), participants must be: 18 to 70 years of age, able to speak 
English, and self-report BMI of 20 and above. Pregnant women will be excluded and only one member per 
household will be enrolled.  
 
For the assessment of implementation study (aim 2), we will recruit up to 18 2-1-1 and Horizons 
leaders/staff selected for a one-time semi-structured interview. Interviews assessing implementation, costs, 
and potential scalability will be conducted with Horizons staff; interviews with 2-1-1- staff will focus on the 
organizations as study referral agencies. We will also conduct interviews with intervention participants via a 
one-time semi-structured interview. We will use two different interview guides (with different participants) to 
ensure coverage of all of our process evaluation questions. The first interview guide will be used for up to 45 
participants with the goal of five participants per healthy action; The second interview guide will be used with a 
total of 35 participants with equal representation by food secure and food insecure participants who chose one 
of the following healthy actions: bring home fresh FV at least once a week and make them easy to see and 
grab; identify one unhealthy food or drink and do not allow it in the house; always have a low-calorie beverage 
available instead of sugar soda or sweet tea. 
 
Community participation 
The EPRC has a long history of engagement with its diverse and active CAB. The CAB was established in 
2004, building on board membership of the SW Georgia Cancer Coalition, renamed Horizons Community 
Solutions three years ago, that represented a group of concerned citizens and community leaders who had 
organized around cancer prevention and control. Our community partners advise on all phases of the research 
including study design, implementation, translation, and dissemination activities. 
 
Recruitment for the Hybrid-effectiveness implementation trial (Aim 1). 
Recruitment will occur either by phone, web, text messaging, or via flyer distribution. Flyers (or IRB approved 
flyer content) may be distributed by any of the four United Way 2-1-1 organizations (United Way of Greater 
Atlanta 2-1-1, United Way of Central Georgia 2-1-1, Chattahoochee Valley 2-1-1 in Columbus, United Way of 
SWGA). Flyers will contain the Atlanta 2-1-1 and United Way of SWGA contact information for those interested 
in the study. The flyer content is included for review prior to production of flyers. In addition, 2-1-1 
organizations may use social media and work with local media, such as TV and radio stations, in promoting the 
study.  Content shared with the media will be consistent with that included in the approved flier and interested 
individuals will contact their local 2-1-1 as outlined below. 
 

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Phone/Text method: Line agents, called Community Connections Specialists at the Atlanta 2-1-1 and United 
Way of SWGA will answer incoming calls and texts at random, which will reduce systematic selection bias. 
After fulfilling service requests for those being recruited via text, a line agent will text participants a canned 
statement and the link to the screener for them to complete on their own (canned statement is included for 
review). After fulfilling service requests for those being recruited over the phone, a line agent will screen and 
invite callers to obtain more information on the study. A quick screening question at the beginning of our 2-1-1 
version of the recruitment script will facilitate efficiency in recruitment (i.e., only those who report interest in 
participating in a study on making homes more supportive of healthy eating of 5 or more (on a scale of 0-10) 
will continue to full eligibility screener). Eligible and interested callers will provide their contact information 
(name and telephone number) and be referred to Emory research staff for further screening and enrollment. 
Atlanta 2-1-1 line agents also answer calls for the Macon and Columbus 2-1-1s.  We anticipate recruiting a 
large proportion of the sample from these two 2-1-1 regions (approx. 40%), 20% from United Way of SWGA, 
and 40% from metro-Atlanta 2-1-1. 
Flyer/Web method: Participating 2-1-1 agencies will have the option of creating a study information flyer for 
distribution (in-person or on their website).  Content of this flyer includes information on study involvement, 
length, compensation, eligibility criteria, and study PI.  Callers will have several different options (phone, text, 
or web link) to be connected to their local agency for preliminary screening.  
 
We expect that 80% of callers will be eligible and based on our feasibility study, 50% will be reachable and 
interested in the research. We anticipate approximately 1700 callers will be referred to enroll 800 participants. 
Emory research staff will contact callers to describe the research activities in more detail, confirm eligibility, 
obtain verbal consent, and enroll them in the study. Participants will provide contact information for themselves 
and a person who can always locate them to aid in retention, and complete the baseline survey on the call.  
Following the completion of the baseline survey, we will call them two more times, to complete two dietary 
recalls. That will conclude their requirements for enrollment into the study. Both 2-1-1 and Emory versions of 
the eligibility screeners are included for review. 
 
Recruitment for the assessment of implementation study (aim 2). 
2-1-1 and Horizons leaders and staff and intervention arm participants will be selected for semi-structured 
interviews.  
 
The following protocol will be used to recruit 2-1-1 and Horizons leaders and staff: 
1. An introductory email notification and up to five reminders will be sent to selected 2-1-1 and Horizons 
leaders/staff inviting them to participate in interviews. Potential participants will be identified by the 
Directors overseeing the centers and/or have a study-related role. The email invitation will include a 
description of the study, study procedures, compensation for completing the semi-structured interview, 
etc. An opt-out option with instructions will be provided in the email notification and no further contact 
will be made with those who remove themselves from further participation. 
2. Those who are interested in participating will be fully informed about the study procedures and 
consented to participate via telephone. The IRB-approved consent statement will describe the purpose 
of the study, risks and benefits, and selection criteria. Participants will be informed that they have a 
right to withdraw from the study at any time.  Information collected prior to withdrawal will remain in the 
study.  All correspondence will contain the PI’s email address and phone number for invited participants 
to use if they have questions.  
3. Research staff will then conduct the semi-structured interview by telephone with consented participants.  
4. Participants will receive $40 for completing the interview. 
 
The following protocol will be used to recruit participants for the process evaluation among intervention arm 
participants: 
1. An introductory letter will be sent to eligible participants from the HH/HF hybrid-effectiveness 
implementation trial inviting them to participate in interviews. Eligible participants include study 
participants (from Aim 1) who have expressed interest in being contacted for a follow-up interview 
during their last study survey. The letter will include a description of the study, study procedures, 
compensation for completing the semi-structured interview, contact information for study staff, etc. 
2. Ten days after mailing the letter, identified participants from the HH/HF hybrid-effectiveness 
implementation trial will then be contacted via telephone and will be told about the study, study 

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procedures, compensation for completing the semi-structured interview, etc.  
3. Those who are interested in participating will be fully informed about the study procedures and 
consented to participate via telephone. The IRB-approved consent statement will describe the purpose 
of the study, risks and benefits, and selection criteria. Participants will be informed that they have a 
right to withdraw from the study at any time.  Information collected prior to withdrawal will remain in the 
study.  All correspondence will contain the PI’s and study coordinator’s email address and phone 
number for invited participants to use if they have questions.  
4. Study staff and students will then conduct the semi-structured interview by telephone with consented 
participants.  
5. Participants will receive $40 for completing the interview. 
 
Field Methods for hybrid-effectiveness implementation trial 
To answer our effectiveness and implementation research questions, we will conduct an RCT with follow-up at 
four months and nine months post-baseline. The four-month post-baseline follow-up will document short-term 
outcomes and process data such as acceptability of the intervention. The nine-month post-baseline follow-up 
will assess maintenance of home food environment and dietary changes. Participants will be recruited by 
United Way of Greater Atlanta 2-1-1 and United Way of SWGA.  EPRC staff will obtain informed consent and 
enroll participants and collect data at baseline and follow-up.  Horizons Community Solutions staff will deliver 
the intervention to participants recruited from outside the Atlanta area and EPRC staff will deliver the 
intervention to callers from the Atlanta area. 
Data Collection Procedures. The telephone interviews will be conducted by trained Emory research staff and 
graduate research assistants.  All data collectors will be blind to group assignment and have no interactions 
with any intervention delivery related tasks, including mailings. At follow-up, if data collectors are unable to 
reach participants with the established telephone-based collection protocol, data collectors will text and email 
participants a unique survey link designed using REDCap for them to complete their home environment 
survey. A final attempt to collect data will be made via mail. Participants will receive a paper copy of the home 
environment survey asking them to complete it and mail it back.  
 
Data collectors will be responsible for confirming eligibility of all interested participants referred by 2-1-1 and 
conducting informed consent to participate in the study.  Once verbal informed consent has been documented, 
the baseline interview will be conducted. Two unscheduled dietary recalls will follow to ensure completion of a 
weekend and weekday recall for each participant. Similar procedures will be executed for follow-up data 
collection #1 and #2. Please see table below for data collection and payment schedules.  
 
 
Recruitment 
& Screening 
Informed 
consent 
Interview 1 
Home 
Environment 
Survey  
Interview 2 
Dietary Recall 1 
Interview 3 
Dietary Recall 2 
Baseline 
X 
X 
$40 
X 
X 
X 
Follow-up 1 (4-months 
post-baseline) 
 
 
$20 
$20 
X 
X 
X 
Follow-up 2 (9-months 
post-baseline) 
 
 
$20 
$20 
X 
X 
X 
 
Dietary recalls will be administered using NCI’s web-based application, ASA24. Although this user-friendly 
application is intended for self-administration, we have also established protocols to aid in researcher-guided 
telephone-based collection. Additionally, data collectors will be trained on proper probing techniques to ensure 
all foods, drinks, supplements, and home-made food item ingredients are included. If data collectors are 
unable to reach participants with the established telephone-based collection protocol at follow-up, data 
collectors will share the ASA24 study link, username, and password via a text message or an email for 
participants to complete their 24-hour dietary recalls on their own. All participants will receive a copy of their 
home environment profile and a list of healthy actions at the end of the study. 
 
 
Baseline and Follow-up Outcome Measures 

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Version #7 
 
Version Date: 1/24/24 
key aspects of motivational interviewing, such as reflective listening and rolling with resistance.64,65 
Immediately after a participant completes baseline data collection, we will generate the home environment 
profile via a secure web-based application and send it along with the other intervention materials (i.e., family 
contract, healthy action checklist and stickers). The home environment profile presents tailored baseline data 
in a user-friendly format that helps participants identify aspects of their home environment that facilitate or 
hinder eating healthy. Tailoring is based on the household food inventory, frequency of grocery shopping for 
fruits and vegetables, frequency of purchasing fast food/restaurant food for family meals, food preparation and 
serving practices, eating in front of the TV, and weight monitoring.  
 
The intervention will be delivered over 12 weeks with weekly contact alternating between phone and text/e-mail 
contact (see Table 3). The Coach will contact the participant one week after baseline data collection to review 
the home environment profile and select 
the first healthy action. On the first call, 
the Coach will review the profile, then 
present a list of low-cost “healthy 
actions” that target possible 
environmental changes to make in the 
home. Using a series of open-ended 
questions, the coach guides the 
participant to select a healthy action to 
work on. This will be followed at weekly 
intervals by text/e-mail check-ins to 
reinforce progress and problem-solve 
challenges. Additional healthy actions 
are added in future calls, for a total of 
three healthy actions across three 
months. The participant will document 
the selected healthy actions on a family 
contract with stickers and their 
signature. The coaching calls, text 
messages and intervention materials 
are designed to increase behavioral 
capability, self-efficacy and behavioral 
intention to improve the home food 
environment for healthy eating and 
weight gain prevention. Participants will 
receive three seasonings, one portion 
size plate, and a magnetic grocery list 
pad after completing their 3rd coaching 
call.  
Control Condition.  Participants in the 
control condition will receive two 
mailings on healthy eating, the first from 
the Dietary Guidelines For Americans 
2015-2020- Eight Edition and the second from Choose MyPlate.66,67  Additionally, both mailings will include a 
food diary from the Centers for Diesease Control and Prevnetion.68 Mailings will be sent to participants one and 
six-weeks post-baseline.  These materials focus on the same dietary outcomes we are targeting, but without 
the home environment emphasis. We will also send control group participants their home environment profile 
with a list of healthy actions upon completion of the study.   
 
 
 
 
 
 

Version #7 
 
Version Date: 1/24/24 
 
 
Field Methods for the assessment of implementation (aim 2) 
Participant surveys, completed one month after the intervention will include a number of process evaluation 
questions. We will ask about receipt of mailed materials, usefulness and relevance of materials, and 
satisfaction with the coaching calls.  Coaches will also complete coaching logs to document goals set and 
barriers faced or anticipated.  Semi-structured interviews will be conducted with four staff at each 2-1-1 (e.g., 
United Way Director, 2-1-1 director, line agent/resource manager and line agent/community connections 
specialist) (n=16) and with the Horizons coach and supervisory staff (n=2) via telephone or Zoom. Semi-
structured interviews will also be conducted with intervention arm participants based on each of the eight 
healthy actions (n=45) and based on participants’ food security status (n=35) via telephone or Zoom for a total 
of 80 interviews. Semi-structured interview guides for 2-1-1 and Horizons leaders and staff will cover topics to 
adoption, adaptation, acceptability, relevance, and maintenance. Semi-structured interview guides with 
intervention arm participants will cover topics related to barriers and facilitators to healthy action progress and 
maintenance, barriers and facilitators to healthy food access and healthy eating, and suggestions for program 
changes or improvements. Interviews will be recorded and transcribed verbatim. All interviews will be 
conducted by personnel not directly involved in other aspects of the study, to minimize social desirability bias. 
All study procedures, including the interviews, will occur by telephone. 2-1-1 and Horizons leaders and staff 
who complete the semi-structured interview will receive a $40 gift card in appreciation of their time. Intervention 
arm participants who complete the semi-structured interview will also receive a $40 e-gift card and/or mailed 
gift card. 
 
Field Methods for cost-effectiveness study (aim 3) 
We will collect program delivery tracking logs, partners’ estimated time and costs as part of the cost-
effectiveness analysis. We will also include data on call attempts for recruitment, program delivery, frequency 
and outcome of call contacts, etc.  Participant surveys, completed one-month post intervention implementation, 
will include a number of process evaluation questions that will be used to assess implementation (from aim 1). 
These data sources will be used for the purposes of program document review to answer evaluation questions.  
INFORMED CONSENT PROCESS 
We will use an IRB approved informed consent prior to conducting any study procedures. Since all of the study 
procedures are telephone-based and we will not have any physical contact with participants, the informed 
consent process will also occur by telephone. Personnel working remotely from home, will document the date 
and time of consent and provide their signature using the REDCap electronic-consent feature that implements 
consent forms through an online survey. This will allow us to keep confidential participant data paper-less and 
securely saved on Emory’s servers. A waiver of written consent document that will be constructed in REDCap 
has been uploaded for approval. 
During the informed consent process, we will describe the purpose of the study, procedures, risks and benefits 
to participating, compensation, and how confidentiality will be maintained. Since contact information for study 
PI and Project Coordinator will be provided, a hard copy of the consent form will be mailed to all participants 
who request it.     
 
 
POTENTIAL RISKS/DISCOMFORTS TO STUDY PARTICIPANTS AND MEASURES TO PREVENT 
OCCURRENCE 
 
We will not be discussing any sensitive topics and we do not expect any of the telephone calls, survey 
questions, or print materials to cause any harm or distress. The primary risk in this study is a loss of privacy or 
breach of confidentiality. We will take standard measures to protect all participants’ confidentiality, as 
described in the Confidentiality section below. The proposed protocol contains minimal risk so no adverse 
events are expected. However, should any adverse event occur, the study staff would immediately alert the 
Principal Investigator (PI), who will have the responsibility of informing Emory IRB.  
 
There are two potential risks for participants in the assessment of implementation study (aim 2), though it is 
important to stress that the overall risk is judged to be very low. First, study participants may experience risks 

Version #7 
 
Version Date: 1/24/24 
related to loss of privacy or breach of confidentiality. Additionally, when participating in the semi-structured 
interview, they may be hesitant or uncomfortable responding to questions regarding intervention 
implementation, relevance, barriers experienced, etc. They will be interviewed by staff not directly involved with 
intervention delivery. We will provide the maximum possible protections so that all participant information is 
protected and participants understand their rights, data purpose, use, and storage.  We will ensure that 
participants are aware their responses are optional and that they have the right to withdraw from the study at 
any time without penalty or loss of benefits. Participation will not be disclosed to their organization or anyone 
outside the research team. All responses will remain confidential and not be shared with anyone except the 
project staff.   
BENEFITS 
 
Participants may benefit from improving their home food environment and/or eating healthier as a result of our 
intervention materials and contact with health coaches. With participants’ help, future 2-1-1 clients and their 
families may benefit from an intervention that is designed to help them improve their home food environment.  
 
COMPENSATION 
Participants will receive a $40 reloadable gift card (ClinCard) as compensation for completing their baseline 
data collection (home environment survey and two dietary recalls). An additional $40 will be loaded to the 
participant’s reloadable gift card after the completion of follow-up 1 and follow-up 2 (HES with 2 dietary recalls 
at 4-months and 9-months post-baseline). We will also load $5 to their reloadable gift card if they respond to a 
text message confirming their contact information at 6-months post-baseline, as a retention strategy. If unable 
to reach them via text we will mail them a postcard that they will have to initial, confirming their contact 
information is the same (postcard is included for review). Once we receive the postcard we will load $5 to their 
reloadable gift card. The total amount that participants are eligible to receive is $125, if they complete all parts 
of this study.  
2-1-1 and Horizons leaders and staff in the assessment of implementation study will receive a $40 Amazon e-
card as compensation for taking part in the interview, and intervention arm participants will receive a $40 
Amazon e-gift card or other gift card (e.g., Walmart) as compensation for taking part in the interview (aim 2).  
DATA MANAGEMENT AND MONITORING 
 
All study staff, including the PI, will participate in the monitoring of participant data. The proposed protocol 
contains minimal risk so no adverse events are expected. However, should any adverse event occur, the study 
staff member who discovered the adverse event would immediately alert the Principal Investigator, who will 
have the responsibility of informing the Emory IRB. The PI will meet regularly with study staff to ensure that 
data security is maintained and data analysis is handled as outlined above. Each study participant will be 
assigned an ID number and surveys will be identifiable via assigned IDs only.  A separate Excel database will 
link identification codes with participants’ names.  Coaches will upload and store all electronic files, including 
audio-recordings, on a secure, password protected network drive that is backed up by the RSPH Office of 
Information Technology.  
 
Data for intervention delivery will be collected via the HHHF Application, a secure electronic intervention 
delivery application which is hosted on Amazon Web Services (AWS). AWS is a secure cloud services 
platform, offering database storage, content delivery, and is a more cost-efficient but equally secure platform to 
host such web-based applications. We have first-hand experience working with AWS and are hosting another 
web-based application there currently. All other data sources will include hard-copy interview guides with 
responses, audio files, and tracking logs. All of the electronic files (including data from REDCap) will be stored 
on the secure network drive and hard-copy files will be locked in a filing cabinet in a locked office only 
accessible to approved research staff and faculty.  While working from home, we are implementing paper-less 
methods of data collection and tracking.   
 
 
DATA ANALYSIS 
 

Version #7 
 
Version Date: 1/24/24 
Data Analysis Plan for the hybrid-effectiveness implementation trial  
All dietary recalls will be collected, processed, and analyzed using the most recent version of ASA24 that 
prompts for food description details and automatically codes and calculates nutrient intakes using the USDA 
Food and Nutrient Database for Dietary Studies.69 The ASA24 provides values for total energy, nutrients and 
nutrient ratios, foods and food groups, and can be used to calculate the HEI to assess diet quality. The ASA24 
program provides a daily total for energy intake and other nutrients (e.g., total fat) and food groups (e.g., fruits 
and vegetables). We will use the average of one weekday and one weekend day to estimate usual short-term 
diet at each time point.   
 
We will assess continuous outcomes for normality and transform them if assumptions are not met. We will 
assess missingness of data by conducting logistic regression analyses with reached/not reached for follow-up 
as the outcome to see if those who were not reached were statistically significantly different from those who 
were not reached.70 Predictor variables will include demographics and other baseline variables such as BMI. 
For all outcome variables, we will also investigate any outliers and will decide on exclusion if they are unusually 
high (beyond 3 SD) or impossible values. However, we will make strong efforts to reduce outliers through 
rigorous data quality control. 
 
To assess the effectiveness of the HH/HF in the 2-1-1 population we will conduct traditional RCT analyses, 
using both complete case and intent-to-treat data (all participants). We will first assess statistical significance of 
change between baseline and each follow-up points with appropriate bivariate tests (e.g., independent t-tests, 
Wilcoxon-Mann-Whitney tests, chi-square tests of independence). We will use growth modeling as the intent-
to-treat analysis as it allows for modeling of all available data without the need for multiple imputations based 
on the assumption of data missing at random.71,72 Hence, we will include any variables identified as being 
related to missingness into these models as covariate. We will utilize multiple imputation if there are issues 
with missing data for individual covariates.73 In general, growth models will include time (calculated as time 
elapsed between the measurement point and baseline date) and an interaction effect between time and group 
assignment. We will assess the intraclass correlation (ICC) due to clustering in 2-1-1 call centers, but based on 
our previous research, ICCs are expected to be very small (< 1%) and we therefore do not anticipate the need 
to adjust for clustering. However, if the need arises, we will adjust for clustering using three-level modeling with 
Bayesian estimators due to the small number of clusters. 
 
Furthermore, we will test differences in intervention effectiveness, i.e., conduct moderator analyses, for 
demographics/household characteristics, and baseline BMI using growth modeling with interaction effects 
between group assignment and the moderators of interest. Finally, we will use Structural Equation Modeling to 
assess changes to the home food environment as mediators as indicated in Figure 4. Data cleaning and 
analyses will be conducted using SAS 9.4 and Mplus 8. 
 
We will also use the addresses of HH/HF study participants to investigate the relationship between food desert 
residence and primary and secondary outcome variables such as diet quality and household food inventories. 
To do so, participants’ addresses will be geocoded using ArcGIS 10.8.2 and assigned to 2010 census tract 
data. These data will then be joined with USDA’s Food Access Research Atlas dataset, which includes census 
tract-level information on food access. Using participant’s census tract as an objective indicator of food access 
de-identifies participants’ home locations.  
 
Data Analysis Plan for the assessment of implementation study (aim 2)  
Descriptive analyses will be run on survey and coaching log/web analytic data to characterize the process 
measures and program implementation. Regarding data from 2-1-1 and Horizons leaders and staff, we will 
conduct analyses pooled across sites and by individual sites (i.e., the four 2-1-1s and Horizons versus EPRC) 
to understand variations in promotion, recruitment, and implementation. We will also develop a codebook 
based on evaluation questions and emergent themes from the transcripts. Two analysts will double code each 
transcript and resolve discrepancies through discussion. NVivo will be used for qualitative data analysis and 
management. We will then generate code reports using NVivo to facilitate identification of themes and develop 
matrices to aid in identifying themes and patterns across key categories such as type of 2-1-1 organization 
(e.g., Atlanta versus Macon/Columbus versus Albany), which differ in terms of staffing structure and 
organizational and community context. A similar approach will be taken for the analysis of qualitative data from 
intervention arm participants. The process evaluation data from program participants will be triangulated with 
the staff interviews to assess multiple stakeholders’ perspectives. 

Version #7 
 
Version Date: 1/24/24 
 
Data Analysis Plan for the cost-effectiveness analysis (aim 3) 
We will conduct a cost analysis and a cost-effectiveness analysis of the intervention, focusing on effects 
associated with improvements in diet (i.e., fruit and vegetable consumption, fewer empty calories) and 
avoidance of weight gain (relative to controls). The analysis will be conducted from the societal perspective 
and assume a lifetime horizon. We will use estimates of effectiveness of the intervention based on the analysis 
described above. In the baseline analysis, we will assume that behaviors persist for participants remaining 
lifetime. We will test the sensitivity of results to reasonable assumptions about effect durability, but most 
studies linking dietary behaviors to health outcomes in the literature focus on binary classifications of behaviors 
rather than exposure time. We will build a model that tracks participants from the beginning of the intervention 
to death. The analysis will conform to Panel on Cost-Effectiveness in Health and Medicine standards for 
conducting cost-effectiveness analyses.68    
 
Direct intervention costs. We will estimate the costs of program delivery in the intervention group. We will not 
consider costs associated with the evaluation of the intervention. Project staff will be asked to keep time logs to 
document time spent on developing and delivering the intervention. We will value staff time based on their 
wages, which are included in the grant budget. For staff who are hired on a full-time basis, we will make a 
reasonable assumption about the share of time they spend on intervention delivery versus research and value 
it accordingly. Indirect costs. We will record the length of time participants spend on the phone with their 
Coach and value time using the median US wage. Use of a wage to value time costs is appropriate even for 
individuals who are not employed because it reflects the opportunity cost of forgone leisure time. Cost-offsets. 
We will focus on the impact of the intervention on fruit and vegetable consumption and obesity. We will follow 
the methods of Rahkovsky and Gregory to estimate cost-offsets from changes in fruit and vegetable 
consumption.69 They estimate the relationships between food prices and non-high density lipid cholesterol and 
use their results to predict the impact of interventions to change the consumption of various types of food 
groups (e.g., vegetables, whole grain products) on cardiovascular disease-related spending. We will use 
estimates from the nutritional epidemiology literature and estimates of disease-attributable costs, some of 
which we have estimated,70 to predict the impact of dietary changes on cancer- and diabetes-specific costs. 
We will use a similar approach to estimating cost-offsets from reductions in obesity that occur independently of 
dietary improvements. 
 
Cost-effectiveness. In the event cost-offsets are lower than the direct costs of the intervention (i.e., it is not 
cost-saving), we will calculate the incremental cost-effectiveness ratio associated with improvements in health 
status due to the intervention. The numerator of the ratio is the change in per participant costs between the two 
groups, including the direct costs of the intervention, indirect costs, and cost offsets. The denominator is the 
change in quality-adjusted life years.  
 
 
TRAINING OF THE STUDY TEAM 
 
Intervention staff at both the EPRC and Horizons will include staff who participated in conducting our prior 
studies on HH/HF.  They and newly hired coaches will undergo a two-day in-person training with built-in 
practice sessions with original program developers and intervention staff. Post-training practice sessions will 
continue until interventionists are well-versed in interpreting the home environment profile, delivering coaching 
calls with appropriate tips and goals, and providing effective reinforcement contacts (via text and phone) to 
reinforce healthy actions and problem-solve challenges.  All participant interactions will be audio-recorded until 
five consecutive coaching sessions and reinforcement calls are delivered successfully. Tailored written and 
verbal feedback will be provided on all recorded sessions for improvement and audio-recordings will continue 
for 10% of subsequent calls throughout the duration of the study. Monthly/quarterly group booster training 
sessions will be held via telephone with all intervention staff to review feedback.  Similar processes will be 
used to train data collection staff with intensive in-person training to be provided by our seasoned study 
coordinator. Training topics will include item-by-item review of baseline and follow-up surveys, data collection 
techniques, multiple call attempt tips, and accurate data documentation will be emphasized.   Baseline and 
follow-up survey data will be documented on hard copy and entered into the HH/HF web-based application to 
generate the home environment profiles.  All hard copy survey data will be reviewed for completion (against an 

Version #7 
 
Version Date: 1/24/24 
audio recording, if available), and feedback will be provided to data collectors as needed. All hard copy data 
will be double-entered into an SPSS database to ensure accurate data entry.  ASA24 data downloads will also 
be reviewed regularly and responses requiring revisions will be reviewed by Dr. Hartman and study faculty. All 
data collection interactions will be audio-recorded until 5 successful surveys and dietary recalls have been 
documented with 10% of recalls being recorded thereafter. Ongoing quality control of dietary recall recordings 
will continue throughout the duration of the study with provision of individual and general group feedback by 
the study coordinator as needed. All study team members have completed (or will complete once identified) 
the necessary CITI certifications to maintain human subject protections. 
 
PLANS FOR MONITORING THE STUDY FOR SAFETY 
Only authorized study staff will have access to surveys, audio files, transcripts, datasets, information that links 
identifiers to subjects, and any other information provided. As previously mentioned, all data will be transmitted 
and saved on a secured research network server of RSPH that can only be accessed by study staff.  
All study staff, including the PI, will participate in the monitoring of participant data. The proposed protocol 
contains minimal risk so no adverse events are expected. However, should any adverse event occur, the study 
staff member who discovered the adverse event would immediately alert the PI, who will have the 
responsibility of informing the Emory IRB. The PI will meet regularly with study staff to ensure that data security 
is maintained and data analysis is handled as described. 
CONFIDENTIALITY 
 
Confidentiality of participant data will be protected at all times. The following procedures will take place: 
a) All study personnel will be thoroughly trained on how to maintain confidentiality.   
b) Each participant will be assigned a unique ID number.   We will use each participant’s ID number 
instead of his/her name whenever we can, including the surveys and during data analysis.  Once the 
data is exported from the HH/HF Application, we will ensure that all personally identifying 
information, such as names, will not be stored in the same electronic data file as other study data.  
c) Contact information obtained from participants will be kept on a secure network server. No hard 
copies of data will be stored. 
d) All data collected will be backed-up on a secure “Research” drive and will only be accessible to CITI 
certified study staff. 
e) Participant names and other facts that might identify a specific participant will not appear when we 
present this study or publish its results.   
f)  We will use digital recorders and files will be stored electronically on a secure and password 
protected “Research” drive. Audio files will be deleted once the study procedures and data analyses 
are complete, or three years after transcription (whichever comes first). 
 
REFERENCES 
 
 
1. 
Key TJ, Allen NE, Spencer EA, Travis RC. The effect of diet on risk of cancer. Lancet. 
2002;360(9336):861-868. 
2. 
Pischon T, Nothlings U, Boeing H. Obesity and cancer. Proc Nutr Soc. 2008;67(2):128-145. 
3. 
Wiseman M. The second World Cancer Research Fund/American Institute for Cancer Research expert 
report. Food, nutrition, physical activity, and the prevention of cancer: a global perspective. Proc Nutr 
Soc. 2008;67(3):253-256. 
4. 
Anand P, Kunnumakkara AB, Sundaram C, et al. Cancer is a preventable disease that requires major 
lifestyle changes. Pharm Res. 2008;25(9):2097-2116. 
5. 
U.S. Department of Health and Human Services. The Surgeon General's call to action to prevent and 
decrease overweight and obesity. U.S. Department of Health and Human Services, Public Health 
Service, Office of the Surgeon General. http://www.surgeongeneral.gov/topics/obesity/. Published 
2001. Accessed September 1, 2008  
6. 
Bray GA, Bellanger T. Epidemiology, trends, and morbidities of obesity and the metabolic syndrome. 
Endocrine. 2006;29(1):109-117. 

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7. 
World Cancer Research Fund, American Institute for Cancer Research. Food, Nutrition, Physical 
Activity and the Prevention of Cancer: A Global Perspective. Washington, DC: American Institute for 
Cancer Research;2007. 
8. 
Colditz GA, Willett WC, Stampfer MJ, London SJ, Segal MR, Speizer FE. Patterns of weight change 
and their relation to diet in a cohort of healthy women. Am J Clin Nutr. 1990;51(6):1100-1105. 
9. 
He XXZ, Baker DW. Changes in weight among a nationally representative cohort of adults aged 51 to 
61, 1992 to 2000. Am J Prev Med. 2004;27(1):8-15. 
10. 
Lombard CB, Deeks AA, Teede HJ. A systematic review of interventions aimed at the prevention of 
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