SPECIFIC AIMS

Xiaolu Hou

There is a pressing need for primary prevention of type 2 diabetes mellitus (T2DM) in the United States
and around the world. It is estimated that 285 million adults worldwide and 25.8 million Americans of all ages
had diabetes in 2010 and 2011, respectively [1, 2]. These numbers continue to grow at an alarming rate, with
the worldwide prevalence of diabetes projected to reach 7.7% (439 million adults) by 2030 [1]. Multiple
randomized controlled trials (RCTs) have shown that lifestyle modification interventions which target diet and
physical activity can delay and even prevent the onset of T2DM [3, 4]. Unfortunately, widespread
incorporation of such interventions into clinical care remains impractical due to the high cost and intensity of
delivery required. Many researchers have begun to explore the efficacy of healthcare interventions delivered
via mobile phones in light of the increasing pervasiveness and decreasing cost of mobile technology. Mobile
healthcare seems particularly well-suited for developed countries such as the U.S. where the number of
mobile phone subscriptions actually exceeds the population [5]. Mobile text messaging heath interventions
have already demonstrated efficacy in increasing adherence to antiretroviral drugs and smoking cessation [6,
7]. Investigations into its use for diabetes have thus far focused on management rather than prevention, but
these studies have yielded some promising effects on such measures as A1C, self-efficacy, eating behaviors,
and diabetes self-care/knowledge [8, 9]. The first randomized controlled trial assessing the efficacy of mobile
text messaging in preventing T2DM was recently conducted on 537 working men (aged 35-55 years) with
impaired glucose tolerance in urban India [10]. This trial reported a significant 9% reduction in the onset of
T2DM in the text messaging intervention versus standard care group [10]. However, additional evidence is
needed to support the effectiveness of this type of intervention in populations that are more diverse for age,
sex, ethnicity, and socioeconomic/employment status. Further research should also elucidate the mechanism
behind the interventions beneficial effect, its cost-effectiveness, and potential dose-dependency.
The general goal of the proposed study is to determine the effectiveness of a mobile phone text
messaging intervention in delaying or preventing the onset of type 2 diabetes among Americans with
prediabetes. We will conduct a 12-month pragmatic clinical trial that employs a randomized controlled design
to evaluate whether a lifestyle modification intervention consisting of computer-generated mobile phone text
messages encouraging and providing guidelines for healthful eating behaviors and physical activity will
reduce body weight and BMI and increase physical activity and healthful eating when compared to a standard
care control. Patients with prediabetes will be randomly assigned to a standard care control, low frequency
text message intervention, or high frequency text intervention group (n=132 for each group). The text
message content will be modeled after that of the 2013 Ramachandran trial [10] based on the transtheoretical
model with tailoring of content to reflect American culture as needed. The low frequency condition will receive
2 messages per week, while the high frequency condition will receive 7 messages per week (daily). The
standard care condition includes referral to a 2-hour course which is currently the standard practice in
regional clinics for addressing diabetes prevention. We will use reach, effectiveness, maintenance, and costeffectiveness analyses to assess the individual impact of these interventions [11].
Primary specific aims of this project will be to determine:
1. The effectiveness of a mobile phone text messaging-based diabetes prevention intervention in
significantly increasing physical activity and healthful eating and reducing body weight and BMI over
12 months among adults with prediabetes (IFG or IGT) when compared to a standard-care group.
Secondary specific aims of this project will be to determine:
2. The effectiveness of a mobile phone text messaging-based diabetes prevention intervention in
enhancing longer term (18 months) maintenance of increases in physical activity and healthful eating
as well as weight/BMI reduction when compared to a standard-care control group.
3. Changes in blood glucose levels, waist circumference, serum lipid levels, blood pressure, and quality
of life at 6, 12, and 18 months.
4. The cost and cost-effectiveness of each intervention arm.
5. The extent to which beneficial effects of the mobile text messaging intervention are dose-dependent.
Finally, the potential impact of this study is that a successful intervention will provide an inexpensive, less
burdensome, and easily scalable alternative for delivering lifestyle modification interventions for the
prevention of type 2 diabetes that can be used in similar settings. This will also be the first trial to determine
the effectiveness of a text messaging-based diabetes prevention intervention in a U.S. population and on
both women and men.

Approach
Table 1. Overview of Research Design
Sample

Participants
396 individuals determined to
have prediabetes through
clinical screening.
Inclusion criteria:
1. Prediabetes
(Fasting Plasma Glucose
level between 100-125
mg/dL or Oral Glucose
Tolerance Test 2-hour
values between 140-199
mg/dL)
2. BMI 25
3. Age 18
4. Ownership of a mobile
phone
5. Pre-action stage of change
Exclusion criteria:
1. Diabetes
2. Major illness (such as cancer
or chronic liver disease) or
other contraindication to
physical activity
3. Severe food allergies or
anything that severely
restricts dietary choice
4. Disorders with cognitive
impairment, severe
depression, or mental
instability
5. Unable to read or speak
English
6. Recruitment in another trial

Study Design

3-Group
Randomized
Controlled Trial
132 participants
assigned to each
of:
1. Low frequency
mobile text
messaging
intervention arm.
2. High frequency
mobile text
messaging
intervention arm.
3. Standard care
(SC) control arm.
Assessments of
primary &
secondary
outcomes at
baseline, 6, 12, &
18 months.

Intervention

Low Frequency Mobile

Text Messaging (LF-MTM)
Intervention Arm
Targets increased exercise
& healthy eating through
computer-generated mobile
phone text messages per
week encouraging &
providing guidelines for
healthful eating behaviors &
physical activity based on
the transtheoretical model.
Text messages will be
delivered 2 times per week
for 12 months.
High Frequency Mobile
Text Messaging (HFMTM) Intervention Arm
Same as the low frequency
intervention arm described
above except that mobile
text messages will be
delivered 7 times per week
(once per day) for 12
months.
Standard Care Control
Arm
Consists of a 2-hour
educational course which is
currently the standard
practice in regional clinics
for addressing diabetes
prevention.

Outcomes,
Mediators,
Moderators

Measures

Primary Outcomes:
1. Physical Activity
2. Dietary Intake
3. Body Weight / BMI

Primary Outcomes:
1. Physical Activity. Accelerometer
2. Dietary Intake. Multiple-pass 24-hour recalls
3. Body Weight / BMI. Scale & stadiometer

Proposed Mediators:
1. Stage of change
[Transtheoretical
Model]
2. Nutrition Knowledge
3. Self-efficacy

Proposed Mediators:
1. Stage of change. Stages of Change
Questionnaire
2. Nutrition Knowledge. Validated nutrition
knowledge questionnaire for Swiss
consumers modified for Americans.
3. Self-efficacy. Eating Habits Confidence
Questionnaire and the Exercise Confidence
Questionnaire

Proposed Moderators:
1. Mobile Technology
Literacy
2. Age
3. Sex
4. Race/Ethnicity
5. Income
6. Employment
7. Education
Secondary Outcomes
1. Blood Glucose
2. Waist Circumference
3. Serum Lipid Levels
(total cholesterol,
HDL cholesterol, &
triglycerides)
4. Blood Pressure
(systolic & diastolic)
5. Quality of Life
6. Cost/
Cost-effectiveness
7. Dose-dependency of
Intervention Effects

Proposed Moderators:
1. Mobile Technology Literacy. Self-reported
frequency of & comfort with using mobile
technology
2. Age / Sex / Race / Ethnicity / Income /
Employment / Education. Self-report
Secondary outcomes:
1. Blood Glucose. FGT, 2 hour OGTT, & A1C
2. Waist Circumference. Measuring tape
3. Serum Lipid Levels. Blood sample
4. Blood Pressure. Seated systolic and
diastolic blood pressure taken 2 times using
the auscultatory method with a calibrated
aneroid sphygmomanometer
5. Quality of Life. 15D tool
6. Cost/Cost-effectiveness. Cost ($) of delivery
by condition and per participant.
7. Dose-dependency of Intervention Effects.
Comparison of LF-MTM & HF-MTM effects

Overview of Our Approach

Previous randomized controlled trials (RCTs) have shown that lifestyle modification interventions targeting
increased physical activity and healthy eating can delay or prevent the progression of prediabetes to T2DM [3,
4], but widespread implementation remains too costly and intensive to be practical. Based on the
pervasiveness of mobile phones in the U.S. and current literature supporting the efficacy of mobile text
messaging health interventions [5-10], we conclude there is a need to assess the effectiveness, cost, and
potential dose-dependency of a mobile text messaging diabetes prevention program delivered to a diverse
U.S. population in a realistic setting. Accordingly, the proposed trial will test the efficacy and costs of a low
frequency mobile text messaging (LF-MTM) program, high frequency mobile text messaging (HF-MTM)
program, and a standard care 2-hour single session diabetes prevention course (SC) in a sample with
prediabetes, as defined by IFG (FPG between 100-125 mg/dL) or IGT (OGTT 2-hour between 140-199 mg/dL)
[12]. We propose to implement this text messaging intervention at two frequency levels to allow us to
determine the minimum level required to produce a significant effect in our primary outcomes as well as to
gauge whether the effectiveness of the intervention varies by dose. Table 1 outlines our RCT design.
Participants
Participant Eligibility. Inclusion and exclusion criteria are detailed in Table 1. These were chosen to
maximize the representativeness of our sample for prediabetes patients in the U.S. and thus to strengthen the
external validity of our results. Ownership of a mobile phone was chosen as an inclusion criterion to prevent
the possibility that total unfamiliarity with mobile technology could confound our results. Mobile phones are
known to be widely prevalent in the U.S. (number of subscriptions exceeds the population) [5], so this criterion
is unlikely to weaken the representativeness of our sample. Finally, since we based the mobile text messaging
intervention on the transtheoretical model [10, 13-14] and propose progression to the Action and Maintenance
stages of change as a key mediator of its beneficial effects, participants must be in a pre-action stage
(precontemplation or contemplation) at baseline to be eligible.
Participant Recruitment and Baseline Assessment Procedures. We will work with health clinics in the
greater Roanoke Metropolitan areaincluding 12 Carilion Clinic sites that currently serve over 150,000
peopleto identify patients with prediabetes (IFG or IGT) on a bimonthly basis. Qualifying patients will receive
a letter explaining the RCT and a pre-paid postcard for them to decline. Those who do not opt out will receive a
recruitment call to discuss concerns, assess remaining eligibility criteria, obtain a participation decision, and if
yes, schedule a baseline appointment. At least 10 days before the appointment, patients will receive by mail
informed consent documents as well as accelerometers with instructions and a baseline survey to fill out and
bring to the first meeting. They will also be directed to wear their accelerometers for 1 week and fast for 12
hours before the baseline appointment. Any baseline measures not already assessed will be taken during this
visit (fasting and 2-hour glucose, A1C, accelerometer data, body weight, height for BMI, waist circumference,
serum lipid levels, and blood pressure).
Sample Size Calculation. We used Greens formula to calculate that a sample size of 105 participants per
group is needed to achieve 0.05 significance level and 80% study power to detect medium-sized effects on our
primary outcomes [14]. Our recruitment goal is to have 132 participants per group to allow for up to 20%
attrition without negative impact to power. We will also provide small financial incentives at each assessment
point and obtain full contact information for each participant as well as contact information for at least one
friend or relative of each participant in order to minimize attrition.
Interventions
After baseline assessments have been completed, participants in the Standard Care Control (SCC) must
schedule a diabetes prevention educational course to attend at a regional clinic within 1 month of baseline.
Participants in the LF-MTM and HF-MTM interventions will be provided with mobile phones for the duration of
the study at no cost to them and informed of the basic format for the messages they will receive as part of the
intervention. They will be sent one test text message toward the end of their baseline visit to ensure that
phones are functioning properly and that they understand how to open and read the message.
Standard Care. All participants randomized to the standard care control group will participate in a singlesession 2-hour educational course which is currently the standard practice in regional clinics for addressing
diabetes prevention. The course will encourage participants to set personal goals for weight loss of 7% of body
weight and increasing physical activity to at least 175 minutes per week in accordance with the principles of the

Diabetes Prevention Program (DPP). We will provide no additional lifestyle modification information or
encouragement to SC participants after this course for the duration of the study. Any remaining contact will be
related to the biannual follow-up assessments.
Low Frequency Mobile Text Messaging (LF-MTM). This intervention was developed to help participants
decrease their risk for diabetes through behavioral changes of increased physical activity and healthful eating.
Text messages to be sent to participants are based on those used in the 2013 Ramachandran trial [10], a
similar text messaging intervention that achieved a 9% reduction in diabetes onset [10]. Since that trial
targeted a U.K. population, modification of the message content was necessary for use with U.S. participants.
Based on the transtheoretical model of behavioral change, messages were designed to move participants from
pre-action to action stages of change through consciousness raising, self and environmental reevaluation,
counter conditioning, and goal-setting [13, 15-16]. One hundred twenty messages have been prepared (evenly
divided between physical activity and healthy eating), each fewer than 160 characters (the limit for a standard
mobile text message). We will partner with commercial service provider Verizon Wireless to create a website to
manage automated delivery of these messages and to send messages cyclically so no message is repeated
within 4 months for either intervention group. LF-MTM participants will receive 2 text messages per week on
the days and at the time of day they prefer, as assessed during the biannual visits. They will continue receiving
these messages for 12 continuous months with assessment visits every 6 months, including a final follow-up
visit at 18 months to assess maintenance of any changes.
High Frequency Mobile Text Messaging (HF-MTM). The 2013 Ramachandran trial on which our program is
modeled sent 2 to 4 text messages per week to its participants [10]. We propose two frequency levels in our
study to investigate (1) the minimum dose to still produce significant benefits, (2) the possibility of greater
benefits from higher message frequency, and (3) the cost-effectiveness of these dosage levels. We based the
low frequency level of 2 messages per week on the bottom limit of the range used successfully in the
Ramachandran study [10]. We decided on 7 messages per week for the high frequency level to test a greater
dose than previously studied but not so high as to irritate participants. Delivery and content of the HF-MTM
intervention will be identical to LF-MTM other than higher frequency of messages.
Measurement and Data Collection
Table 1 illustrates the primary and secondary outcome as well as proposed mediator and moderator
measures. Our key time points for data collection are also contained in the table.
Physical Activity. Physical activity is a primary outcome for this intervention as well as a proposed mediator
of any potential improvement in blood glucose levels. PA will be measured directly using ActiGraph monitors
worn by participants around the hip or lower back for 7 days prior to each assessment visit (baseline, 6, 12,
and 18 months) [17]. The reliability and validity of ActiGraph accelerometers is well-documented in both lab
and field settings, although it may slightly underestimate activity in the latter [18-21]. Aside from objectivity, the
ActiGraph also offers advantages of small size, ease of operation, and large data storage capacity to the
benefit of both participants and researchers.
Dietary Intake. Since half of the intervention text messages promote healthy eating habits, dietary intake is
another primary outcome and proposed mediator for any improvement in prediabetes indices that may result.
DI will be assessed with the USDA Automated Multiple-Pass Method (AMPM) for 24-hour recall used for
NHANES. This method has been shown to reduce bias in the collection of energy intake data though it is still
susceptible to underreporting [22]. However, since this trial focuses more on detecting changes in intake than
on absolute intake, we feel it has demonstrated sufficient reliability and validity for use in our study. We will
also request contact information for a significant other, close friend, or relative who will be able to validate each
participants eating patterns. We will not actually use contact these people for assessment purposes (only to
minimize attrition), but it should serve as a bogus pipeline to increase the validity of the recall data.
Body Weight / BMI. Body weight and BMI are primary outcomes of this study. Body weight will be
measured using digital scales of the same brand and model, and scales will be calibrated for accuracy before
every assessment period. Height will be measured directly with a stadiometer. BMI will be calculated using
weight and height measurements using the standard formula of kg/m2.
Blood Glucose. A large body of research shows that lifestyle modification interventions targeting diet and
physical activity can delay and even prevent the onset of type 2 diabetes [3, 4]. We have thus chosen
improvements to fasting glucose, glucose tolerance, and/or A1C as secondary outcomes of this intervention.
Fasting glucose and glucose tolerance will also be measured at baseline to confirm participant eligibility based

on IFG and IGT as defined by the most recent American Diabetics Association (ADA) Standards of Medical
Care [12]. To assess Fasting Plasma Glucose for each participant, we will draw a venous whole blood sample
at every assessment visit after the participant has fasted for 12 hours. We will then perform an Oral Glucose
Tolerance Test (OGTT) in accordance to World Health Organization (WHO) guidelines, using a 150-ml
beverage containing 75 g of anhydrous glucose dissolved in water [12]. A second venous whole blood sample
will be taken 2 hours after the participant drinks the beverage to assess glucose tolerance. We also plan to
assess A1C since it is ADA-approved for diagnosing diabetes/prediabetes and previous diabetes mobile text
interventions have shown promising improvements in A1C [8, 9]. Research evidence suggests that A1C also
offers the advantages of being a better index of overall glycemic exposure and risk for long-term complications,
exhibiting greater preanalytical stability, and having fewer daily fluctuations (including during times of stress or
illness) than FPG or 2-hour OGTT [23]. According to the 2013 ADA standards, hemoglobin A1C levels will be
tested using a method certified by the National Glycohemoglobin Standardization Program and standardized to
the Diabetes Control and Complications Trial reference assay [12]. Assessing multiple measures will ensure
that no beneficial effect of the intervention on blood glucose is missed. For all blood draws, samples for each
participant will be obtained at the same time of day (within a 30-minute range) at each assessment visit.
Similarly, samples will be taken between 6:00-9:00 am for all participants in this study.
Waist Circumference, Serum Lipids, and Blood Pressure. Overweight, obesity, abnormal lipid metabolism,
and hypertension are widely recognized to be risk factors for the development of T2DM [12]. As such,
improvements to these are secondary outcomes and potential mediators of intervention effects on prediabetic
indices in this study. Waist circumference provides an indicator of visceral fat, which is not adequately reflected
in total weight or BMI values. Research supports large waist circumference as a strong risk factor for T2DM
especially at low BMI levels [24]. We will assess waist circumference directly using measuring tape. Serum
lipid levels (total cholesterol, HDL-C, LDL-C, and triglycerides) will be measured from blood samples drawn at
each assessment visit. Lastly, seated systolic and diastolic blood pressure will be measured twice using the
auscultatory method with a calibrated aneroid sphygmomanometer and an appropriately-sized cuff based on
National Heart, Lung, and Blood Institute guidelines for maximum accuracy [25-26]. Appropriate precautions
including staff training and instrument calibration will be taken to ensure the accuracy and consistency of the
tools and raters used for all measurements.
Quality of Life. Quality of life (QOL) is a secondary outcome of this study since the intervention may benefit
a participants QOL even if other measures have not been affected to a significant level. Assessment of QOL
can also help identify unanticipated negative effects outside of the biological and psychological measures we
have identified. We will use the 15D tool, a comprehensive self-administered measure of health-related QOL
demonstrated to be highly reliable, sensitive to change, and especially valid for deriving quality-adjusted life
years (QALYs) that can be used to analyze cost-effectiveness of programs [27].
Cost/Cost-effectiveness. Cost and cost-effectiveness are secondary outcomes of this study. We will
estimate total costs for each treatment, cost per participant, and cost per pound of body weight lost and per 30
minute increase in weekly physical activity. All research staff will diligently record intervention-related activities
performed, time spent performing them, and material resources used on a daily basis. Specific care will be
taken to isolate research-specific costs that would not apply to real-world implementation of the intervention.
Resources used as part of the intervention will be valued at competitive market rates. We will include all costs
required for each treatment, including that of identifying and recruiting participants and of developing then
delivering the text messages. Additionally, we will use the QALY framework which is widely accepted as the
reference standard [28], to calculate and compare cost-effectiveness between treatment groups. Participant
QOL data will be used to derive QALY values for use in these analyses.
Dose-dependency of effects. Effects of the LF-MTM and HF-MTM interventions on individual-level outcome
measures will be compared to determine whether a higher treatment dosage (i.e., receiving more text
messages per week) produces greater health benefits and, if so, the magnitude of additional benefit.
Stage of Change. Our text messaging intervention is based on the transtheoretical model. A central
concept of this model is that individuals use stages of change (SOC) to progress through an intended behavior
change and must progress through each stage in a specific order to successfully change a behavior [10, 1314]. Since our intervention was designed to move participants from pre-action to action SOC in physical activity
and eating behaviors, we plan to assess the current stage of change of each participant as both an inclusion
criteria and a proposed mediator for the interventions effects at baseline, 6, 12, and 18 months. We will use a
brief SOC questionnaire to assess SOC for increasing physical activity and healthy eating intentions and

activities [29-30]. No gold standard currently exists for categorizing SOC [30], but this method has been
reported to be reliable across varying problem behaviors [30-32].
Nutrition Knowledge. Nutrition knowledge has the potential to be a mediator, moderator, and confounding
factor in this study and will be assessed prior to randomization to ensure even distribution between treatment
groups as well as during biannual assessment visits. We will assess nutrition knowledge using a validated
questionnaire for Swiss consumers which we have adapted for American participants [33].
Self-efficacy. Self-efficacy is an important construct of the transtheoretical model and acts as a mediator,
moderator, and/or confounding factor in this study. We plan to assess self-efficacy prior to random assignment
and at biannual assessments with the Eating Habits Confidence Questionnaire and the Exercise Confidence
Questionnaire used in a recent RCT of lifestyle interventions on blood pressure [34].
Proposed Moderators. Mobile technology literacy, age, sex, race/ethnicity, income, employment, and
education level all have the potential to moderate and/or confound the results of this trial. Consequently, we
plan to assess these prior to random assignment. Income, employment, education level, and mobile
technology literacy will continue to be assessed at each biannual visit. Age, sex, race/ethnicity, income,
employment, and education level will be self-reported through a written survey. We could find no existing
validated tool to measure the specific mobile technology literacy relevant to this study. Since technology
literacy is not the primary focus of this study, we feel that self-reported frequency of and comfort with mobile
technology use will be a suitable measure for this intervention.
Data Management and Analysis
Data Management. Research staff at Virginia Tech will be trained and certified in data collection and
management methods and monitored throughout the study for quality control. All participant data will be
assigned numerical codes and will be kept separate from any identifying information. Charts linking numerical
codes with participant names and other identifying information will be stored separately in a secure location. All
paper as well as electronic data containing participant information will also be stored in a secure location within
our research facility. We will back up all electronic data at least once per day.
Data Analysis. Appropriate statistical methods will be used to compare qualitative and quantitative
variables among the treatment groups at baseline. If differences are found, we will use demographic traits as
covariates in our models. We will also compare primary and secondary outcomes, proposed mediators, and
selected proposed moderators at baseline, 6, 12, and 18 months to identify outliers, abnormal values, and
missing data. Intention to Treat analysis will be used to include all participants that start the study, whether
they finish the trial or not, in comparisons and treatment effects analysis. Appropriate models will be chosen to
analyze effectiveness on individual and treatment group levels for outcome, proposed mediator, and proposed
moderator measures. Reach of the intervention will be analyzed taking several dimensions into account. First,
we will calculate participation rate, i.e. the number of eligible individuals who received our initial letter versus
the number who ultimately participated. We will also evaluate the representativeness of our participant sample
by comparing the basic demographic characteristics of our sample to Virginia state and national level U.S.
Census statistics. In addition to our biological and psychological outcome measures, we will examine overall
QOL as it may highlight broader positive or negative effects outside of the designated outcome measures.
QOL as well as primary outcome and costs of intervention data will also be used in a detailed economic
analysis to determine the overall and per participant costs of each intervention arm. If the HF-MTM intervention
is found to produce greater effects than the LF-MTM intervention, we will also examine whether per participant
costs and cost-effectiveness vary significantly by frequency level. Lastly, we will compare data from the 18
month (6 months after intervention text messages stop) and 12 month assessment points to evaluate
maintenance of intervention effects on the individual level.
Potential Challenges and Limitations and Our Planned Approach to Them
There is the potential for challenges and limitations to any study, and the same is true of our proposed trial.
One issue could be the recruitment of the 396 participants required to give this study appropriate power within
a reasonable amount of time. We have made this task more manageable by working with regional clinics using
existing electronic record systems to screen for eligible participants. We are hopeful that proactive recruitment
calls, biannual financial incentives, and the low intrusiveness of all 3 treatments in our study will increase the
participation rate and reduce the amount of time and resources needed to reach our recruitment goal. Another
potential issue is that the mobile service provider could suffer outages that prevent some of the intervention

text messages from being delivered or participants may be in a no-service zone when the message delivery
attempt is made. To minimize the impact of service issues, the website we developed to manage delivery of
these messages will document delivery of each message and retry sending any failed messages every 15
minutes until they are successfully delivered. If there is a known outage of the Verizon network in the region,
sending of messages will be delayed until the outage has been resolved. Data regarding failed and delayed
messages will be analyzed at the end of the study to determine whether service disruptions may be frequent
enough to impact the effectiveness of the intervention though we do not anticipate this to be the case.

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