Assessing Home Food Environment and Diabetes Self-management Among Adult Type 2 Diabetes Patients
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Sponsor: University of Nebraska Lincoln

Assessing Home Food Environment and Diabetes Self-management Among Adult Type 2 
Diabetes Patients 
 
ClinicalTrials.gov identifier: NCT03039569 
 
 
Date: June 1, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol  
The current research project was approved by the University of Nebraska in Lincoln, 
Nebraska and the Methodist Health System in Omaha, Nebraska. Study participants were 
recruited from the Methodist Health System Center for Diabetes and Nutritional Health in 
Omaha, Nebraska. The center is an ambulatory outpatient clinic for treatment of patients with 
diabetes. Inclusion criteria were adults aged ≥ 30 years with Type 2 diabetes; self-reported 
hemoglobin A1C >6.5%, having a cellular phone with the ability to receive text messages and 
English speaking.  
 A quasi experimental design was used in this pilot study due to timeframe restraints. 
Eligible participants who came into the clinic for outpatient diabetes management care were 
identified and approached  A survey regarding participants’ demographics and, relevant risk 
factors for Type 2 diabetes was completed by all the participants (intervention and control group) 
at baseline.. The intervention group started approximately two months earlier than the control 
group.  Participants in both the intervention and control groups received the usual care for Type 
2 diabetes including an initial visit  from either a Registered Dietitian or Certified Diabetes 
Educator and follow-up visits.  The intervention group received three messages weekly (on 
Mondays, Wednesdays and Fridays) for 12 weeks based on topics regarding nutrition education 
and diabetes self-care information and skills.  The messages were different each week during the 
first six weeks (Weeks 1 to 6) and repeated during the remaining weeks (Weeks 7 to 12). The 
messages consisted of strategiesto increase fruits and vegetables and reduce high-fat and sugary 
foods intakes and  to improve diabetes self-care skills, increasing physical activity, and increase 
awareness of  CVD rick perception and knowledge (Table X). The text messages were derived 
from the topics and guidelines provided by the American Association of Diabetes Educator 

(AADE) including “Reducing Risks”, “Monitoring”, “Healthy Coping”, “Problem Solving”, 
“Taking Medication”, “Healthy Eating”, and “Exercise”.  Each text message included the novel 
approach of including a link to a specific AADE7 topic and handout that allowed participants to 
open and retrieve the specific AADE7 information. Unidirectional text messages were sent by 
the project investigators to the participants in the intervention group via a computer-based text 
messaging program through a password protected computer which was only accessed by the 
investigators. Participants’ phone numbers used for text message intervention was kept private, 
and they were advised not to reply to the text message. If a participant had a medical concern 
about his/her diabetes, he/she was advised to contact his/her physician or call 911. The control 
group (usual care group) did not receive text messages. Participants in both the intervention (text 
messaging + usual care) and control group completed surveys regarding their awareness of CVD 
risk, diabetes self-care activities, dietary intake, and physical activity at baseline and at 12-week  
follow-up (conclusion of the intervention).   Further, the participants in the intervention group 
completed a survey to evaluate their satisfaction with receiving text messaging for managing 
diabetes after the text messaging intervention was concluded. A $25 gift card were offered to 
participants in both intervention and control groups.  
Statistical Analysis  
Primary analyses were based on participants in the intervention group or control group at 
the time of the initiation of the intervention (baseline) regardless of adherence status (intent-to 
treat analysis).  Baseline characteristics were calculated using descriptive statistics and compared 
between groups using t test for continuous variables and Chi-square analyses for categorical 
variables. Treatment effects were evaluated by assessing the differences in the outcome variables 
from baseline to the 12-week follow-up between participants in the intervention group and the 

control group using Proc Glimmix procedure.  The model included the intercept, time effect 
(baseline and follow-up), and interactions between treatment groups (intervention and control 
groups) and the time effect (the absolute treatment effect).  Least squares means were calculated 
for each time and treatment combination and the differences were calculated between treatments 
within each time point. Estimates of the absolute treatment/intervention effect were determined 
as follow: [(intervention group follow-up) – (intervention group baseline)] – [(control group 
follow-up) – (control group baseline)]. To provide perspective on the magnitude of the 
treatment/intervention effects, we also calculated proportional treatment/intervention effects, 
defined as (absolute treatment/intervention effect/intervention group baseline) × 100% (e.g., a 
proportional effect of 55% would mean a 55% increase in the intervention  group relative to the 
control group). The analyses were repeated after the adjustment for unbalanced baseline 
characteristics (race/ethnicity, education) and the results did not change materially.  SAS 
software (SAS Institute, Cary, NC) was used for analyses. All tests were 2-sided, and P < 0.05 
was considered statistically significant.