This study will test the following hypotheses:Primary: The DirectLife program is effective in increasing the level of physical activity in an ageing populationSecondary:1. The level of physical activity associates with parameters of 24-hour glucose…
ID
Source
Brief title
Condition
- Other condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Health condition
veroudering
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary end points
• Level of daily activity, as measured using the DirectLife activity monitors,
expressed as activity counts per day (cnts/d).
• We will use continuous glucose monitoring to assess at least the following
parameters of 24-hour glucose rhythms: i) mean glucose level during , ii)
standard deviation of all 24 hour glucose measurements, iii) highest peak after
a meal (including one standardized oral glucose loading), iv) difference
between highest and lowest level, v) nadir glucose.
Secondary outcome
Secondary end points
- Other metabolic and anthropometric parameters, : weight, waist hip ratio,
body fat percentage (BIA) and blood pressure will be measured at baseline and
at the final visit, and blood sampling for total cholesterol, HDL-cholesterol,
triglycerides, fasting glucose, fasting insulin and HbA1c
- Well being and perceived health will be assessed by Quality of Life (QoL)
SF-36 questionnaire prior to the trial and after the trial
- sleep quality will be assessed by the Pittsburg Sleep Quality Index before
and after the intervention.
Background summary
With an increasingly ageing population, there is a need for lifestyle
interventions that can be implemented at a population level to improve health
in old age and increase healthy lifespan in the general population. Healthy
longevity has been associated with enhanced glucose tolerance and insulin
sensitivity, characteristics that can be modified by increasing physical
activity. The Philips Directlife program is a web-based lifestyle intervention
directed at increasing daily physical activity consisting of 1) an activity
monitor, 2) a personal website, and 3) a personal e-coach. Glucose metabolism
can be measured with minimal invasive measures and sensitively using a 24-hour
glucose sensor (continuous glucose measurement, CGM) placed subcutaneously in
the abdomen.
Study objective
This study will test the following hypotheses:
Primary:
The DirectLife program is effective in increasing the level of physical
activity in an ageing population
Secondary:
1. The level of physical activity associates with parameters of 24-hour glucose
rhythms in an ageing population
2.An increase in physical activity associates with beneficial changes in
24-hour glucose rhythms as measured with CGM, and with changes in metabolic
parameters,anthropometry, well-being and/or sleep quality.
Study design
Open, randomized-controlled trial
Intervention
Intervention Group: Philips Directlife Intervention Program, consisting of
baseline 1 week assessment period of baseline physical activity, after which 12
weeks of program aimed at increasing daily activity, using an activity monitor,
a personal website and a personal e-coach.
The control group will do the 1-week assessment period but will not do the
12-week Directlife intervention program.
Study burden and risks
All study components are minimally or non-invasive. The sensor used in the
continuous glucose monitoring system is placed in the abdominal subcutaneous
tissue during four days. The sensor is inserted using a needle the size of a
regular venipunction and is 1,5 cm long, and is inserted in a 45 degree angle.
Once inserted, the needle is removed and a plastic and flexible sensor is left
in place, which is 1,3 cm long and 3 mm wide. The outward part of the sensor is
only a few centimeters in size, very flexibel and thus comfortable to wear. It
is water-proof, and fixated, therefore sports (including swimming) and bathing
can be performed as usual. Potential side effects include irritation, infection
or bleeding around the place of insertion.
The measurement of glucose rhythms during four days may elude disturbances in
glucose metabolism that warrant further diagnostics for glucose intolerance
and/or diabetes mellitus.
Venous blood sampling could lead to small hemorrage around the needle insertion
location.
Benefits of participation in the current study protocol include a lifestyle
intervention directed at increasing physical activity that is free of costs for
study participants and may lead to health benefits related to increased
physical activity level. All participants, including those initially assigned
to the *no intervention* group, will have this benefit.
Postbus 9600
2300 RC Leiden
NL
Postbus 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
Age between 60-70 years
Low level of physical activity at baseline (as assessed by physical activity questionnaire)
motivation to engage in a more active life style
access to PC and knowledge how to use it
Exclusion criteria
Known diabetes mellitus type I or II
- Severe physical condition that inhibits increase in physical activity
- Use of glucose lowering medication
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 | NL34350.058.10 |