To evaluate the effectiveness of a multidisciplinary outpatient group-based nutrition and lifestyle intervention program *Reverse diabetes type 2* executed by Voeding Leeft on self-reported haemoglobin A1c (Hb1Ac) as measure of glucose regulation…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Self-reported HbA1c values and medication use assessed via online
questionnaires.
Secondary outcome
Other than HbA1c self-reported T2D biomarkers, subjective health parameters,
sleep, dietary intake, physical activity and program adherence.
Background summary
Prevalence of type 2 diabetes (T2D) is increasing rapidly and lifestyle
interventions to reverse diabetes are seen as a possible solution to stop this
trend. Long-term practice-based evidence is needed to gain more insight in the
actual, and above all scientific, basis for these claims.
Study objective
To evaluate the effectiveness of a multidisciplinary outpatient group-based
nutrition and lifestyle intervention program *Reverse diabetes type 2* executed
by Voeding Leeft on self-reported haemoglobin A1c (Hb1Ac) as measure of
glucose regulation and medication use. Secondary outcomes include other
self-reported T2D biomarkers, subjective health parameters, sleep, dietary
intake, physical activity and program adherence.
Study design
An observational study with a quasi-experimental design and stepped-wedge
inclusion of participants.
Study burden and risks
Participants of this observational evaluation study complete online
questionnaires on T2D biomarkers, medication use, general well-being, sleep,
lifestyle and socio-demographics at 7 time points, each lasting 30-45 minutes
(baseline, 1, 3, 6, 12, 18 and 24 months). A subset of participants is asked to
complete 3 web-based 24h recalls at 4 time points, each estimating to take 30
min.
Risk-benefit analysis: The risks in this observational evaluation study are
minimal as partakers are participants of a lifestyle intervention program
executed by Voeding Leeft and this evaluation study by the Louis Bolk Institute
only involves completing a number of online questionnaires. Questionnaires
assess T2D biomarkers if available and which are mostly already collected as
part of their standard medical care according to the Dutch NHG Standard for T2D
for insulin users; for non-insulin users this requires up to 3 additional
measurements of T2D biomarkers requested through their GP or nurse practitioner
which in practice already happens for the majority of T2D patients not taking
insulin.
The potential benefits are huge as this research provides information on the
effectiveness of this lifestyle intervention program, when shown effective and
in line with the pilot study, could benefit those with T2D which is an
increasing public health problem.
Nieuwezijds Voorburgwal 21
Amsterdam 1012AR
NL
Nieuwezijds Voorburgwal 21
Amsterdam 1012AR
NL
Listed location countries
Age
Inclusion criteria
All participants of the Voeding Leeft program can participate in this evaluation study.
Exclusion criteria
None.
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 | NL67513.081.18 |