Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03650088 |
| Other study ID # |
18-1078 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 20, 2019 |
| Est. completion date |
February 26, 2021 |
Study information
| Verified date |
December 2021 |
| Source |
University of North Carolina, Chapel Hill |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to 1) adapt a weight loss app that the Tate team has previously
developed to promote PA and diet and adapt them to the needs and perspectives of those with
Type 2 Diabetes (T2DM), integrate daily monitoring of BG using continuous monitoring (CGM)
and self-monitoring of diet using the simplified system, and develop appropriate displays of
data to facilitate comprehension and decision making, 2) develop the modified intervention
and, 3) conduct a pilot and feasibility study on short-term impacts of the intervention in
overweight adult patients with T2DM not treated with medications in preparation for an R01
submission.
Description:
Over 30 million Americans (nearly 10%) have diabetes, with the majority diagnosed with type 2
diabetes (T2D). The burden of T2D is costly with reduced quality of life, and increased
morbidity, mortality, and health care expenditures. The majority of those with T2D are
overweight, yet weight loss has been shown to be effective in the prevention and treatment of
T2D.
In a 2017 Consensus Statement by the American Association of Clinical Endocrinologists and
the American College of Endocrinology, the authors recommend weight loss of 5-10% for those
with T2D whose BMI is > 25 kg/m^2 through comprehensive lifestyle intervention. Comprehensive
lifestyle interventions are the gold standard in the behavioral treatment of obesity and
diabetes. These evidence-based interventions include diet and physical activity prescriptions
to reduce energy intake and increase expenditure; employ a variety of behavioral techniques
to support these changes; and include in-person support from a multi-disciplinary team of
interventionists. Changes in diet and activity as well as weight loss are essential for
glycemic control in T2D. Lack of glycemic control leads to cardio- and micro-vascular
complications that can significantly contribute to morbidity and mortality.
Self-regulation of behavior is an intervention approach to manage weight and to control blood
glucose. Self-regulation involves having a goal, having access to information about whether
the goal is being achieved, and if not, taking steps to restore equilibrium.
The intervention will be delivered through weekly in-person individual sessions and utilize a
mobile phone app that integrates the diet, weight, physical activity and blood glucose data
to support self-regulatory behaviors. In the first weekly session, participants will be
oriented to the intervention and provided with their self-monitoring tools. They will be
encouraged to weigh and track physical activity, Red foods and blood glucose (BG) daily and
taught to use self-regulatory techniques for weight management and glycemic control. Similar
to blood glucose self-regulation, participants are taught to compare the number on the scale
each day to a standard or goal (weight loss goal) and, depending upon the comparison, make
changes to their diet (i.e., Green foods or Red foods) or physical activity (i.e., moderate
to vigorous physical activity (MVPA) or sedentary behavior(SB)) as needed. All participants
will be given an initial weight loss goal of 5%.
Dietary Intervention
The specific recommendations for diet composition for T2D are consistent with the Traffic
Light Diet concept and the investigators hypothesize that it can be used as a tool to
encourage diet changes that will result in weight loss but will not be as burdensome as
traditional calorie or carbohydrate monitoring methods. Rather than tracking calories as in
traditional behavioral interventions, dietary goals and monitoring will be food-based. In the
Traffic Light Diet, foods are categorized into Green, Yellow and Red categories. Users are
encouraged to increase Green foods, moderate Yellow foods, and limit Red foods. Foods in the
Green category include fruits, vegetables and certain very lean proteins, are low in
calories, fat and sugar and rich in nutrients. The high volume, water content and fiber in
fruits and vegetables and the protein from the lean meats and egg whites in this category
help promote satiety while consuming fewer calories. The Yellow category includes moderately
lean proteins, legumes, low fat dairy, whole grains, starchy vegetables, and low fat
dressings. These foods are higher in calories than green food but are still a good source of
nutrients. Red foods are high in calories, fat, and/or sugar and are not a good source of
nutrients. The goal in the Traffic Light Diet is to increase Green foods and to limit Red
foods. This emphasis on increasing healthful eating has been hypothesized to reduce feelings
of deprivation and hunger. Participants in this study will be allowed unlimited Green foods.
Each participant will be given a personalized Red foods goal which will take into account
baseline consumption of Red foods as well as baseline weight. During the formative
evaluation, the investigators will be modifying the Red foods lists and goal recommendations
based on patient and provider feedback. The underlying basis for the goal should result in a
decrease in calories of 500-1000 per day which is consistent with standard behavioral
treatment. Participants will only monitor Red foods to start. During individual counseling,
interventionists will have the option to set a goal for Green foods and have the participant
monitor those in the app if weight loss is not progressing as desired. Lesson content will
model building healthy meals around green foods and participants will be provided with meal
plans and recipes.
Physical Activity Intervention
The ultimate goal for the study will be to progress the participant to 150-200 minutes of
moderate to vigorous physical activity. An initial goal will be based on baseline levels of
PA as established during the first week of the study. Progression will occur each week based
on individual progress of the participant. The participant will additionally focus on
reductions in sedentary behavior with a study goal of exploring the feasibility of this
alternative.
Study App
During the first individual session, the interventionist will work with the participant to
download the app onto the participants' smartphone, familiarize them with the app, and set
personal goals for weight, diet and physical activity, and BG monitoring.
Weight Goal and Monitoring--Participants will be provided a cell-enabled digital scale and
instructed on setup and procedures for daily weighing.
Dietary Goal and Monitoring--Interventionists instruct on the Red foods list and monitoring
of Red foods in the app. They will be instructed on portion size estimation and
self-monitoring best practices (timing proximal to consumption). During the first week,
participants will be advised to follow their normal diet in order to establish a baseline
intake of Red foods. In the second session, the interventionist will work with the
participant to set an initial Red foods goal.
Physical Activity Goal and Monitoring--Participants will be provided with a digital activity
tracker and will set up the device and the app to allow for data transfer. Based on baseline
physical activity from the first week of monitoring, the interventionist will work with the
participant to set a goal for weekly physical activity minutes. Participants will also be
advised on using the activity tracker to monitor sedentary time and to target sedentary
behavior throughout the day.
BG Goals and Monitoring--Participants will be provided with an a Continuous Glucose
Monitoring (CGM) unit. Recent advances in technology have made CGM much less invasive and
simplified, thereby allowing for a better picture of glucose control given the number of data
points available without the burden that previous CGM units presented. The interventionist
will work with the participant to set goals for monitoring and ensure comprehension of CGM
procedures.
Feedback: The app will provide text and graphic feedback comparing goals to behaviors and
encourages adherence to the goals of daily weighing, monitoring and meeting Red foods and
physical activity goals, and feedback on BG. For the purposes of this study, more rigorous
intervention feedback will be delivered by the interventionist at weekly sessions.
Behavioral Lessons
A standard behavioral intervention based on the Diabetes Prevention Program (DPP) will be
adapted for this protocol. Behavioral weight control approaches are founded on teaching
skills and providing the support necessary to enable participants to adhere to the diet and
physical activity prescription in their intervention. For the dietary intervention, materials
will be adapted to reflect the Traffic Light Diet focus and modules for decreasing sedentary
behavior will be added to those for increasing MVPA. Materials will be adapted with a focus
on T2D. Lessons will be presented within the app and also available on paper at the
individual counseling session. Brief review of the content will be done to assess
comprehension and to explore personal applications.
Coaching Support
Individual counseling sessions will be semi-structured and led by Master's level or higher
interventionists trained in behavioral weight control. Sessions typically last 30-45 minutes.
Interventionists will review food, weight and activity progress through an administrative
portal prior to individual sessions. During the weekly session, the interventionist will
review self-monitoring records with the participant, set weekly goals, review behavioral
lesson content introduced in the app, facilitate problem solving of any barriers the
participant is having, and adapt treatment recommendations based on the needs of the
participant. During the pilot phase, interventionists will record notes on the session to
collect process data that will inform the continuing adaptation of the app and intervention
protocols. This process data will also help to inform algorithms which will be developed in
future studies to standardize counseling protocols for remote delivery and also to automate
feedback in the app with the goal of broader dissemination.
