Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05666323 |
| Other study ID # |
HCI139694 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 23, 2022 |
| Est. completion date |
February 8, 2023 |
Study information
| Verified date |
May 2024 |
| Source |
University of Utah |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The objective of this project is to evaluate strategies to increase patient engagement in
evidence-based interventions (EBIs) for obesity. The scientific premise of the proposed
project is based on: 1) substantial evidence that EBIs for obesity are effective but grossly
underutilized, 2) promising results indicating that technology-based approaches such as text
messaging may increase the reach of EBIs among underserved populations, 3) data demonstrating
that repeated offers of treatment can substantially increase enrollment even among patients
who are initially unmotivated, and 4) prior research highlighting the effectiveness of
Motivation And Problem Solving (MAPS), a proactive coaching approach used to address barriers
to improve patient enrollment in EBIs.
Thus, the proposed project will develop, implement, and evaluate two strategies for
increasing the assessment and enrollment of University of Utah Medicaid patients in online
EBIs for obesity: 1) Repeated offers of EBIs for obesity using text messaging and state of
the science health communication strategies, 2) MAPS navigation/counseling among patients who
do not enroll in EBIs in response to text messaging. The proposed project will provide
critical data regarding the implementation of pragmatic and scalable interventions that are
designed to increase the reach of existing EBIs for obesity among underserved populations.
Most importantly, the project results lay the foundation for the widespread dissemination of
strategies to increase use of EBIs for obesity across Utah, the Mountain West region, and the
nation.
Project deliverables include 1) a text messaging intervention for facilitating connection to
EBIs for obesity; 2) MAPS intervention for facilitating connection to EBIs for obesity; 3)
implementation, adaptation, and optimization of these interventions for University of Utah
Medicaid patients, 4) preliminary evidence for the efficacy of these two interventions in
improving the reach of EBIs for obesity, and 5) creation of a plan for further dissemination.
Description:
This study will use a Sequential Multiple Assignment Randomized Trial (SMART) Design, which
will allow participants to address questions like those of traditional factorial design and
assess dynamic treatment regimens to inform the development of adaptive interventions. An
adaptive intervention contains a sequence of individually tailored decision rules that
specify the intensity or type of intervention at critical points in the delivery of care.
Modifying intensity or type of intervention over time can improve outcomes if an individual
is not responding, or may reduce costs and patient burden if more resource intensive
treatment is not necessary. As such, the proposed SMART design informs the development of
adaptive and stepped care interventions, and the reduction in patient burden is particularly
important to ensure that the interventions are as patient centered as possible.
The first randomization is a patient-level randomization to text messaging (single) versus
text messaging (multiple) among eligible patients. The second randomization is a
patient-level randomization to Motivation And Problem Solving (MAPS) coaching vs. no MAPS
among the remaining patients in the text message conditions who do not enroll in the EBI. The
primary outcome for this study is enrollment in an online EBI for obesity. IncentaHEALTH
provides EBIs for obesity to the University of Utah Health system, either the Diabetes
Prevention Program or Lifestyle Change Program. Their online Diabetes Prevention Program
(DPP) is fully recognized by CDC.
Study Design:
To identify the cohort for the intervention, patient data will be extracted from the
University of Utah EHR. Data fields will include variables such as age, gender, body mass
index, pregnancy status, medical codes (e.g., ICD-10 for Type 1 and Type 2 diabetes), patient
demographics (e.g., zip code, insurance status, preferred language, race/ethnicity); as well
as contact information for text messaging and patient navigation. Patients who fit within the
inclusion/exclusion criteria will be randomly selected and assigned to the conditions
described below.
This study will take place in two Stages spanning a 6-12 month period. In Stage 1 (0 - 12
weeks), participants will be randomized to one of two conditions: Text Messaging 1 (Single
text; hereafter referred to as TM1), or Text Messaging Plus (Multiple texts; hereafter
referred to as TM+). The study team will use a 1:1 randomization ratio (TM1: TM+).
Prior to being contacted via text message, participants in the TM1 and TM+ conditions will
receive an e-mail informing participants that they will be receiving communications from The
University of Utah Health about the availability of a healthy lifestyle program. The e-mail
will provide patients with information about how they can opt-out if they do not wish to
receive these communications. Patients who do not have a valid e-mail address on file will be
contacted via mail with instructions regarding how to opt-out.
Patients in the TM1 condition will receive one HIPAA-compliant bidirectional text message
with the option to reply "yes" or opt out. The text will include a brief motivational message
including information about DPP eligibility and the opportunity to enroll. Patients who reply
"yes" will be contacted by IncentaHEALTH to enroll in the DPP or a similar lifestyle change
program, depending on patient eligibility. Patients who enroll or opt out of receiving text
messages will not be contacted again.
Patients in the TM+ condition will receive a HIPAA-compliant bidirectional text message
weekly for the first 2 weeks and then every three weeks through week 12. Patients will
receive text messages until they opt-out or reply "yes" to enroll. The text will include a
brief motivational message including information about DPP eligibility and opportunity to
enroll. Patients who reply "yes" will be contacted by IncentaHEALTH to enroll in the DPP or a
similar lifestyle change program, depending on patient eligibility. Patients who enroll or
opt out of receiving text messages will not be contacted again.
In Stage 2 of the study (weeks 13-24), patients will be randomized as follows:
Patients randomized to the TM1 condition in Stage 1 who did not respond to the single text
message by 12 weeks (i.e., enroll in the EBI or opt out) will either be randomized to receive
Motivational And Problem Solving (MAPS) counseling (TM1 & MAPS), or will not be contacted
again (TM1 cont'd). Participants randomized to TM1 & MAPS will receive two MAPS calls during
Stage 2.
Patients randomized to the TM+ condition in Stage 1 who did not respond to the text messages
by 12 weeks (i.e., enroll in the EBI or opt out) will be randomized either to receive
continued (monthly) text messages and MAPS counseling (TM+ & MAPS) or continued (monthly)
text messages only (TM+ cont'd). Participants randomized to TM+ & MAPS will receive two MAPS
calls during Stage 2.
Prior to being contacted by the MAPS counselors, participants randomized to the MAPS
conditions in Stage 2 will receive one text message informing the participants that a MAPS
counselor will call the participant about enrolling in a lifestyle change program. This text
message will also provide participants with an opportunity to opt out from having a MAPS
counselor call the participants.
Text Messaging Intervention
The study team will send bidirectional texts to patients. Text messages have been designed by
the research team in consultation with the current research literature. All text messages
will be sent using U Health's HIPAA compliant text messaging service, which has previously
been utilized by our team. The text messaging service will retrieve the patient cohort from
the study database to send the TMs to the patients. Every text message will include the
option to opt out to cease receiving text messages at any time. Patients are routinely
contacted by clinics via phone calls, emails, and text messages; therefore the text messages
are not beyond the scope of routine care and correspondence.
Text messages will include a motivational message, the Diabetes Prevention Program phone
number, and a simple two-touch response that directly connects interested patients to the
Diabetes Prevention Program. Patients in the TM+ condition will be randomized to one of three
types of motivational messages: 1) autonomy supportive motivational messaging; 2) directive
motivational messaging; and 3) a combination of autonomy supportive and motivational
messaging. Patients in the TM1 condition will be randomized to receive either an autonomy
supportive message, or a directive motivational message. The two types of messages do not
fundamentally alter the intervention and this will support exploratory analyses only.
Motivation And Problem Solving (MAPS) Intervention
MAPS is an empirically validated proactive coaching approach used to address barriers and
motivate participants to engage in EBIs. Trained MAPS counselors will directly contact
patients via secure telephone line to assess their motivation and provide counseling related
to enrolling in the EBI. As with the text messages, patients can opt out of MAPS counseling
at any time. University of Utah Health currently employs patient navigators and community
health workers to perform patient navigation for various reasons (e.g., coordination of care,
resource referral); therefore, patient navigation is not beyond the standard of care for
patients.
IncentaHEALTH EBIs for obesity
IncentaHEALTH will triage interested patients into either online DPP or lifestyle change
using a CDC risk assessment tool. Their lifestyle change program uses the same general
components as the DPP. Both programs are designed to increase intake of fruits, vegetables,
lean protein, and complex carbohydrates while monitoring portion size. Physical activity
recommendations include cardiovascular and strength training, with a goal of approximately 30
minutes 5-6 days/week. Both are offered in English and Spanish, based on social cognitive
theory, and provide personalized health coaching. Both include a website, Bluetooth wireless
scale for weight monitoring, daily email/text message support, video exercise plans,
customized meal plans, grocery lists, and incorporate skill building, social accountability,
and reinforcement. Participants have unlimited online access to Health Coaches, who have at
least a Bachelor's degree and certifications in personal training, nutrition, or wellness.
