1. To determine the robustness of an e-supported lifestyle coaching program within the first line health care setting of the Leiden region and to explore factors that influence successful integration of the coaching program in the usual care in the…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective 1: implementation and integration in first line health care
setting
* Lessons learned from GP and PA experiences: regarding their preferences and
user needs.
* Lessons learned for future implementation in general practice: fit within
diabetes *ketenzorg* processes, number of patients approached and number of
patients entering the program and number of and reasons for patients leaving
the program.
* Lessons regarding user needs and design requirements (infrastructure,
architecture, security) for future digital reporting to participating GP*s
(General Practitioners) and their PA*s (Physician Assistants) about effects of
the intervention and progress achieved, to be used in regular care in order to
reach sustainability of behavioral change.
The research team will conduct brief telephone interviews with GP and PA after
two weeks (together with the telephone based briefing of patient progress)
regarding user needs and design requirements for future digital reporting and
regarding implementation barriers and facilitations for implementation of the
intervention in regular care.
Secondary outcome
Secondary objective 2: effect of the intervention
* Impacts on healthy lifestyle behaviors, measured with BRAVO [standardized
survey], on Health Related Quality of Life [RAND SF-8 survey] and exercise
capability (aerobic & resistance/strength tests). Progress reports of outcomes
of the intervention on behaviors and effects will be provided to GP and PA
after 2 weeks and at the 10-week out-take coach session.
* Fasting plasma glucose, HbA1C, total cholesterol, HDL cholesterol and
triglyceride levels, blood pressure, BMI [as monitored within standard first
line diabetes-2 care]
* Medication requirements (insulin, metformin, statins, antihypertensives)
Background summary
Our Western lifestyle plays a large role in the onset and progression of
diabetes mellitus type 2 (Lim 2011). Insulin resistance has an important role
in creating a vicious circle, where medication needs generally increase over
time. Moreover, increasing blood glucose and insulin levels speed up the
processes of weight gain, insulin resistance, inflammation, aging and
comorbidity (like CVD, kidney failure , cancers, neuropathy and dementia)
(Hotamisligil 2010). Hence, reducing insulin dependence and insulin resistance
can be seen as an important therapeutic goal. This can be achieved with healthy
lifestyle improvements.
Several lifestyle interventions have yielded improved outcomes in type 2
diabetes patients on insulin therapy, most notably: lower blood sugar and lower
medication needs (Jenkins 2008; Esposito 2009). However, these are often highly
controlled interventions. Moreover, the long-term sustainability of behaviors
is limited. The question is: can we do this on a more *Do-It-Yourself* and
e-Supported basis? This would have two advantages. First, since behavior
improvements are implemented within patients* lives, it improves the chance of
sustained health behavior (Simons 2013). Second, it is cheaper. Since 2010 the
Health Coach Program has been used to improve lifestyle and metabolic outcomes
(including reduced insulin needs for diabetes-2 patients), via eSupport,
improved self-management and rapidly improved health behaviors (Simons 2010,
Simons 2012). The intervention combines improving health literacy with active
behavior change support.
Study objective
1. To determine the robustness of an e-supported lifestyle coaching program
within the first line health care setting of the Leiden region and to explore
factors that influence successful integration of the coaching program in the
usual care in the general practice.
2. To assess the effects of lifestyle support in patients with insulin
dependent type 2 diabetes mellitus after 10 weeks and after 20 weeks additional
follow up on:
* Health behaviours, Health-Related Quality of life, and exercise capability.
* Fasting glucose levels, and medication needs (insulin, metformin) [as
monitored by patients].
Study design
Non-randomized, one arm lifestyle intervention pilot project, 10 weeks, plus 20
weeks additional follow up.
Intervention
eSupported Lifestyle Intervention
An extensive eSupported lifestyle program is offered, which combines coach
sessions with electronic dashboarding and self-management, plus electronic
health tips and a digital health quiz game. Intensive coaching is offered for 5
weeks with the purpose of generating self-propelling behaviors and
capabilities. The support in weeks 6-10 is increasingly aimed at fostering
self-management, and includes group sessions at the end of weeks 7 and 10,
weekly electronic tips and a digital health game. For the next 20 weeks a light
weight support program is offered, with monthly group sessions, plus monitoring
of physical activity patterns.
The lifestyle advice follows the guidelines of the Harvard Epidemiology and
Nutrition Group for nutrition and physical activity, with specific
modifications for diabetics. The guidelines are to increase intake of
vegetables and low sugar fruits (each 2,5 servings/day or more), to choose
whole grains instead of refined grains, to limit sugar and other high glycemic
load foods, to have one daily serving of nuts and/or legumes, to limit intake
of red meat and processed meat, to limit intake of trans and animal fats, and
to have no more than 2 (male) or 1 (female) alcoholic beverages/day. Physical
exercise guidelines are: at least 60 min/day moderate intensity activity (like
walking or gardening) and at least 3x30 min/week intensive activity (Borg level
12-14).
Study burden and risks
Patients will potentially benefit in terms of reduction of metabolic risk
factors for cardiovascular disease and cancer, reduction of medication use,
improved quality of life (more energy, better self esteem). Potential harms are
cardiovascular complaints during physical exercise.
Zernikedreef 11
Leiden 2333CK
NL
Zernikedreef 11
Leiden 2333CK
NL
Listed location countries
Age
Inclusion criteria
* Type 2 diabetes mellitus treated by insulin therapy.
* BMI ><= 28 kg/m2
* Age 30-80 yrs
* Dutch language and basic computer competence (for use of email and web based dashboard)
Exclusion criteria
* Recent (< 3 months) myocardial infarction
* Uncontrolled blood pressure (SBP > 170 mmHg and/or DBP > 100 mmHg, 2 out of 3 measurements)
* Any chronic disease other than type 2 diabetes hampering participation (at the discretion of the investigator)
* Low motivation to participate (score 2 *weak* or 1 *very weak* on a 5-point scale).
* Alcohol consumption of more than 28 units per week, and no intentions of moderation.
* Psychiatric disease (as defined by DSM-V)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60909.058.17 |