Training Course for Prevention Managers Type 2-Diabetes Module 2: Course Organisation, Recruitment, Networking, and Evaluation Management LOGO IMAGE LOGO

Training Course for Prevention Managers Type 2-Diabetes

Module 2: Course Organisation, Recruitment,

Networking, and Evaluation Management

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Training Course for Prevention Managers T2Dm Module 2: Course Organisation, Recruitment,


Topics of Module 2:

- Course Organisation

- National legislation, rules, and conditions in the field of lifestyle change interventions

- Recruitment of participants (persons at risk)

- Networking with other „players“ in the field of prevention

- Evaluation of prevention programmes

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Major Learning Objectives of Module 2

At the end of the course the prevention manager should be able to … 1. … describe national/local concepts for the structure of a lifestyle change

programme in respect to number, duration, contents, costs, and responsible professionals of the teaching/counselling/training units.

2. … describe national legislation, rules, and/or conditions for the programming of a lifestyle change intervention course, e.g. in respect to the qualification of the teacher/trainer, remuneration conditions, ….

3. … know the process of advertising, informing, recruiting and enrolling people at risk for lifestyle change programmes considering national conditions and situations.

4. … develop and set up a professional network supporting the recruitment and the organization of a lifestyle change intervention.

5. … design an appropriate evaluation protocol which is managable at his own institution/center.

6. … communicate the results of the group work concerning module 2

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Organization of a lifestyle change intervention programme

An important initial step of the organization of a lifestyle change intervention programme is the discussion and

definition of its structure, including:- the number and the duration of the teaching/training units,

- the contents and methods of each unit,- the responsible professionals giving the units,

- the remuneration/costs for the institution as well as for the participants

- ...

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National regulations influencing the implementation of a

lifestyle change intervention programme

Requirements for the qualification of the teacher/trainer:...

- Remuneration conditions and regulations:...

- ...

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Recruitment of persons at risk/participants for a lifestyle change intervention programme

In contrast to persons being and feeling ill, our target group for lifestyle change programmes has no health complaints and feels quite well. So the respective persons at risk have to be identified,

informed and motivated for enrolling in such a programme. Necessary steps are:

- Making the general population sensitive for the idea of prevention, healthy living and lifestyle change*

- Advertising the programme- Information and counselling of interested persons*

- Process of enrollment

*) incl. the use of a diabetes risk score

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Making the general population sensitive for the idea of prevention, healthy living and lifestyle change

At a national level, includingPolitical decisions (who pays?);

Definition of communication strategies; screening methods; lay-out; participating institutions, ministries, associations;

cooperating famous actors ...

&

Advertising the programmeAt the level of the respective prevention center, including

... [to be defined]... ...

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Are there any limitations and potential harm of promoting a healthy lifestyle and respective prevention programmes ?

There has to be valid evidence for the diagnosis „You are at high risk“ and for the efficacy of of the intervention. A specific preventive intervention always implies individual and economical burden and even may be contra-productive for overall health.

So we have to consider the following aspects in our promotion activities: - There have to be good reasons to alarm people in respect to their way of

living and to spend money for respective measures!- Attention in the elderly: At a certain age the message may be: „You are

doing all right! Eat and drink whatever you like – and beware of underweight!

- Attention in the young ones: Promoting less fat, less sugar, more physical activity ... may support the counterpart of the problem: increasing prevalence of underweight and eating disorders in adolescents.

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Information and counseling of interested persons&

Process of enrollmentTo be organized at the level of the respective prevention center.

Example of a component of these steps: material of the Mayo Clinic/USA (http://www.mayoclinic.com/health/weight-loss/NU00266):

Weight-loss tip: First, make sure you‘re readyAsk youself these [12] questions to see if you‘re ready to start a weight-loss program.By Mayo Clinik staffYour weight-loss success depends on your readiness to take on the challenge. These questions

can help you judge wether now is the best time to start your weight-loss program.- Are you motivated to make long-term lifestyle changes that require eating healthy foods

and exercising more?- Do you currently have distractions in your life that could affect your commitment to a

weight to a weight-loss program?- Do you truly believe that slower is better?- Are you realistic about your weight-loss goal?

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CORE9.1

http://www.mayoclinic.com/health/weight-loss/NU00266



Example of a component of these steps: material of the Mayo Clinic/USA (http://www.mayoclinic.com/health/weight-loss/NU00266):

(Continuation of Weight-loss tip: First, make sure you‘re ready)- Do you have family and friends to support your weight-loss efforts?- Do you believe that you can change your eating habits?- Are you willing to become more physically active?- Do you have time to keep records of your food intake and physical activity?- Are you willing to look at past successes and failures in weight loss and other areas of

your life?- Do you view a healthy-weight program as a positive experience?- Have you resolved any eating disorders or other emotional issues that make it difficult for

you to achieve a healthy weight?- Do you believe that a healthy weight is a lifelong commitment?

If you answered yes to all of these questions, you‘re ready to make the lifestyle changes necessary for permanant weight loss.

If you answered no to one or more of these questions, you may not be ready. And that‘s OK! Explore what‘s holding you back ...

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http://www.mayoclinic.com/health/weight-loss/NU00266



Networking for a successful organizationof lifestyle change programmes

A lively and vivid cooperation with other professionals and institutions supports the success of your programme, such as

- Other nutrition experts: ...- Experts in physical activity/leisure centers: ...

- Physicians: ...- Pharmacies: ...

- ...- ...- ...

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Evaluation management

The out-come of your intervention activities should be evaluated in order to optimize the programme continuously.

For that reason a pre-post approach seems recommendable, measuring previously defined parameters in each participant before the start of the intervention (pre) as well as at certain follow-ups (post) after having started, e.g. after 6, 12, 18, ... months. The evaluation parameters of a life style intervention programme can be divided in various areas, such as:

- Characteristics of the participant- Extent of participation in the programme units and satisfaction with the program - Final end point(s)- Surrogate parameters- Quality of life- Parameters related to physical activity- Parameters related to nutrition

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Evaluation parameters of a lifestyle change intervention programme I

Characteristics of the participant (data collected only at baseline)Name, sex, day of birth, height, ...

Extent of participation in the programme units and satisfactionPercentage of participation (monitored at each unit)

Satisfaction e.g. by questionnaire (during+at the end of the program)Final end point

Manifestation of Type 2-diabetes mellitus [yes/no]Surrogate parameters

Oral glucose tolerance testGlucose concentration (fasting?pp)Insulin concentration (fasting?pp)Blood pressure

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Evaluation parameters of a lifestyle change intervention programme II

Quality of lifeQuestionnaire, e.g. SF 12, SF 36, WHO 5

Parameters related to physical activity andParameters related to nutrition

will be discussed in detail in the respective modules

For a successful evaluation it is crucial for each institution/center to define a selection of managable parameters out of the entire list of possible or desirable parameters. This cut down depends on the amount of money, time, and personnel the respective center can afford for the evaluation process.

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Evaluation sheet for lifestyle interventions (Example, max. version) Characteristics of the participant: Name ..... Date of birth: dd-mm-yyyy

Address/ Tel. ...... Height: xxx cm

- Type 2 diabetes m.[y/n]- Oral glucose tolerance test- Glucose (fasting/pp) [mg/dl]- Insulin (fasting/pp) [μU/ml]- Blood pressure (syst/dist)- Quality of life [resp.testscore]- Participation in the prog. [%]- Satisfaction with the progr.- Physical activity rel. param.

- ...- ...

- Nutrition related parameters - ...- ...

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initially 6 Mo 12 Mo 18 Mo ... NO



Evaluation sheet for lifestyle interventions (Example, medium version) Characteristics of the participant: Name ..... Date of birth: dd-mm-yyyy



- ...- ...


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initially 6 Mo 12 Mo 18 Mo ... NO -



Evaluation sheet for lifestyle interventions (Example, medium version) Characteristics of the participant: Name ..... Date of birth: dd-mm-yyyy



- ...- ...


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initially 6 Mo 12 Mo 18 Mo ... NO -

As part of the planning process (and part of the project report) each prevention manager has to define for his own institution which evaluation parameters are managable in the daily routine of the respective unit. For example, the determination of the insulin concentration is expensive and questionnaires may be quite time consuming to instruct and to evaluate.

But: The paramters finally defined should be evaluated in all the participants in order to avoid missing data.



Need for the analysis and presentation of data on an intention-to-treat basis

Problem: How do I manage missing data in follow-up exams or drop-outs?

Years ago the Per Protocol- (PP-) Method was commonly used, including only subjects with complete data sets (initial/baseline data as well as data for the last follow-up). With this method the (often unsuccessful) drop-outs were excluded.

The Intention-to-Treat- (ITT-) Method includes all the subjects who were

initially assigned for the study. There are two ways to treat missing data or drop-outs:- Baseline Data Carried Forward (BDCF): Baseline data are used as values for the last follow-up; or- Last Observation Carried Forward (LOCF): last available data are used as values for the last follow-up.

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Simplified example for the data sets of the 10 subjects having started a study

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CORE 18.1

Subject Baseline 6 Mo 12 Mo PP-Method

ITT-BDCF

ITT-LOCF

1 90 92 -

2 90 - -

3 92 94 -

4 92 - -

5 94 - -

6 94 - -

7 96 - -

8 96 - -

9 98 94 90

10 98 94 90



Example for the calculation of data using the PP-Method

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CORE 18.2

Subject Baseline 6 Mo 12 Mo PP-Method.

ITT-BDCF

ITT-LOCF

1 90 92 -

2 90 - -

3 92 94 -

4 92 - -

5 94 - -

6 94 - -

7 96 - -

8 96 - -

9 98 94 90 90

10 98 94 90 90

Ø 98 (n=2) Ø 90

n=2



Example for the calculation of data using the ITT-BDCF-Method

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CORE 18.3

Subject Baseline 6 Mo 12 Mo PP-Method

ITT-BDCF

ITT-LOCF

1 90 92 - 90

2 90 - - 90

3 92 94 - 92

4 92 - - 92

5 94 - - 94

6 94 - - 94

7 96 - - 96

8 96 - - 96

9 98 94 90 90 90

10 98 94 90 90 90

Ø 94 (n=10) Ø 90 Ø 92,4

n=2 n=10

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Training Course for Prevention Managers Type 2-Diabetes Module 2: Course Organisation, Recruitment, Networking, and Evaluation Management LOGO IMAGE LOGO