Efficiency of a blended care version of an effective diabetes diet

Type 2 diabetes (T2D) affects 422 million adults worldwide, of whom
approximately 85% are overweight or obese. In the Netherlands, over 1 million
people already have T2D, and it has been estimated that 1 out of every 3 Dutch
adults will develop T2D in his or her life (1, 2). When a person with T2D is
also obese, he or she will have more complications, more cardiovascular disease
and even die 7 years earlier (3). Weight loss alleviates this problem, inducing
various beneficial effects in these persons, such as improved glycemic control,
lipid profile and blood pressure (4). However, sustainable weight loss is
difficult to achieve without professional help. Previously, we showed in our
POWER trial that a diet program based on a very low-calorie diet led to long
term (2 year) weight loss, improved quality of life, less depression and a
lower need of insulin. The addition of a cognitive behavioral therapy did not
improve this effect (5). In an evaluation of the program, we found that 95% of
the participants would recommend the program to others.
With the growing rates of T2D and obesity, the pressure on our health care
system increases in terms of morbidity and costs (6).
In order to be successful, lifestyle intervention programs need to be of high
intensity (with frequent contacts) and multidisciplinary, making them costly
and limited to available human resources (7, 8). E-health, using innovative
technologies, is a promising tool to provide obesity care at a lower cost than
face-to-face interventions, especially when extended follow-up is needed.
Moreover, e-health applications may increase access, improve convenience,
increase participant engagement and have the potential to reach more people
(9-11). The effectiveness of e-health interventions has been shown to improve
when adding interactive components (like self-monitoring and goalsetting),
making use of video material and text-messaging. However, e-health
interventions are still less effective in producing weight loss than
face-to-face *in-person* treatment (12-14).
Hypothetically, the combination of in-person treatment with e-health solutions
(*blended care*) is the most (cost)effective (10). The (cost)effectiveness of a
blended care very low-calorie weight loss intervention in people with type 2
diabetes has not been studied to date.

Primary Objective:
1. What is the efficiency of a blended care version of the POWER diet (Blended
POWER), compared to the POWER diet used in usual care (usual care POWER
program): is Blended POWER equally effective in reducing weight after 1 year in
people with T2D and obesity, while lower in costs?

Secondary Objective(s):
1. What is the effectiveness of the Blended POWER intervention with regard to
cardiovascular risk factors and quality of life, compared to the usual care
POWER program?
2. What is the effectiveness of the Blended POWER intervention with regard to
patient satisfaction and attrition/compliance, compared to the usual care POWER
program?
3. Is there a difference in effectivity and patient satisfaction of the Blended
POWER intervention between males and females?
4. Is there a difference in effectivity and patient satisfaction of the Blended
POWER intervention between participants of Dutch or other origin?

We aim to answer our research questions by conducting a randomized, controlled,
non-inferiority trial during 1 year in the outpatient diabetes clinics of
secondary and tertiary hospitals. Moreover, we aim to prospectively collect
data on patient satisfaction and compliance with the intervention.

After signing informed consent, participants will be randomly assigned to
either the control or intervention group.
Both groups will receive the POWER diet program, which is based on a very
low-calorie diet (VLCD) with meal replacements, plus a stepped care approach to
reintroduce a healthy and sustainable long term diet according to national
guidelines. The POWER diet program has been shown effective in producing long
term (2 year) weight loss of 5%, improved quality of life, less depression and
a lower need of insulin, and has been implemented in usual care. Participants
in the control group will follow the usual care POWER diet program and will
receive 1 individual intake meeting, 5 group meetings and 4 planned contact
moments by mail or phone (more whenever it*s necessary for the glucose
regulation).

In the intervention group, the face-to-face contact will be partly replaced by
an e-health application ('blended POWER diet intervention').
In-person contact will be limited to 1 individual intake meeting and 3 group
meetings. The e-health application will consist of a diet-app, with
complementary website. In this app, the steps of the diet-intervention will be
explained via text, short videos and infographics, including Turkish and Arabic
voice-over, for our non-native Dutch patients. Participants will receive
recipes and tips useful for the phase of the diet the participant is in.
Exercise is monitored and encouraged with personal goal setting (using the
National guidelines of the *Kenniscentrum Sport*) and if possible with activity
trackers. We incorporated behavioral change techniques to enhance long-term
behavioral change: challenging dysfunctional cognitions on lifestyle, weight
and body perception, improving self-efficacy and motivation. Personal
goalsetting with respect to diet, exercise, weight, body composition, glucose
levels, medication use, physical complaints and quality of life will be used
and monitored within the app. Moreover, participants will receive motivational
messages to keep them on-track. To make the app more interactive, the
participants can use a chat-function with the dietitian, at specific times. The
app will be end-to-end encrypted, according to the national privacy rules.

The burden and risk associated with participation is considered to be low. The
addition of an e-health application to a diet intervention that is considered
standard care, will not provoke extra risk or burden to the participants,
besides the burden of being aware of one*s disease more often. Participants are
asked to come for four extra visits at the outpatient clinic for study
measurements (same for control and intervention group), give a blood sample
three times (combined with routine lab) and fill out questionnaires on patient
characteristics, quality of life, depression, treatment costs and satisfaction
and attitude towards e-health at three time points.