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Table 1 From SLIM to MetSLIM: considerations and choices regarding the inclusion and exclusion criteria

From: Adapting an effective lifestyle intervention towards individuals with low socioeconomic status of different ethnic origins: the design of the MetSLIM study

Criteria

Original study protocol: SLIM [10]

Considerations

Adapted study protocol: MetSLIM

Inclusion criteria

Mean 2-h blood glucose ≥ 7.8 and ≤12.5 mmol/l

Primary outcome measure of MetSLIM will be waist circumference (see considerations Table 2). There is an on-going discussion about the use of different waist cut-off points for different ethnicities. In order to take height differences between ethnic groups into account, waist-to-height-ratio (WHtR) was chosen as selection criterion [14]. In order to observe a change in waist circumference, only persons with an elevated WHtR will be included [15].

WHtR ≥ 0.5

Mean fasting blood glucose ≤ 7.8 mmol/l

Caucasian

The adapted intervention is aimed at individuals of Dutch, Moroccan or Turkish ethnic origin. Moroccans and Turks are the two largest non-Western ethnic minority groups in the Netherlands [16].

Persons of Dutch, Moroccan or Turkish descent

Age 40–70 years

In the Netherlands, life expectancy without chronic diseases is 8.9 years lower in women and 10.9 years lower in men among the least educated group compared to the most educated group [17]. Also, the onset of T2DM among the Moroccan and Turkish population living in the Netherlands occurs at an earlier age compared with Dutch people [9]. Apparently, prevention of chronic diseases should start at an earlier age among our target group.

Age 30–70 years

No additional inclusion criteria

As the adapted intervention study is aimed at low SES individuals, the researchers had to investigate where and how they would ideally reach this target group. Commonly used indicators for SES are income, education level and occupation. However, these are individual level indicators and this could create recruitment difficulties. It might be uncommon and illogical for the target group to be selected for lifestyle programmes on the basis of their individual education level, income or occupation. Furthermore, it is more practical to recruit in specific areas and use the postal code as indicator for SES [18]. A disadvantage of using the postal code is that more highly educated persons will also be able to participate in the intervention study. However, the advantage of recruiting in neighbourhoods is that participants will live in the same neighbourhood. This offers us the opportunity to provide all activities close to the participants’ home and to focus on group cohesion and social support in the community.

Living in deprived neighbourhood

Exclusion criteria

Known diabetes mellitus

See consideration WHtR as inclusion criterion.

WHtR ≤ 0.5

Mean 2-h blood glucose > 12.5 mmol/l

Mean fasting blood glucose > 7.8 mmol/l

Any chronic disease that makes 5-year survival improbable or that interferes with glucose tolerance, or that makes participation in a lifestyle intervention impossible

Participants must be able to follow a lifestyle programme for one year.

Any mental or physical disability that makes participation in a lifestyle intervention impossible

Medication know to interfere with glucose tolerance

Since the adapted lifestyle programme aims to decrease waist circumference and improve other factors of metabolic syndrome, persons taking medication for CVD and/or T2DM will be excluded.

Medication for hypertension, hypercholesterolemia, cardiovascular diseases, diabetes mellitus or/and renal failure

Participants in a regular vigorous exercise programme

In order to measure the effectiveness of the lifestyle programme, participants should not already be participating in other lifestyle programmes.

Participation in another regular vigorous exercise and/or diet programme targeting weight loss

No additional exclusion criteria

Since the minimum age of participants was decreased to women’s fertile years, pregnant or lactating were added as exclusion criteria, as these have an influence on the main outcomes of the MetSLIM study.

Pregnant or lactating