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Table 2 Overview of outcomes and time point of data collection

From: Study protocol for a pragmatic cluster randomized controlled trial to improve dietary diversity and physical fitness among older people who live at home (the “ALAPAGE study”)

TIME POINT

 

Week 1

Week 2

Week 3

Week 4

Week 5

Week 6

Week 7

Week 8

Week 18

Week 19

I

S0

S1

S2

S3

S4

S5

S6

Home

Home

V3

T0

  

T1

 

T2

C

V0

V1

   

Home

V2

 

Home

V3

T0

   

T1

 

T2

ASSESSMENTS

Primary outcomes

  Dietary diversity (2 24-hour recalls + 1 FFQ)

I

X

X

   

X

X

 

X

X

C

X

X

   

X

X

 

X

X

  Lower limb muscle strength (Senior Fitness Test)a

I

  

X

      

X

C

 

X

       

X

Secondary outcomes effectiveness evaluation

  Physical fitness (upper body strength, aerobic endurance, flexibility, dynamic balance) (Senior Fitness Test)a

I

  

X

      

X

C

 

X

       

X

  Static balance

I

  

X

   

X

  

X

C

 

X

    

X

  

X

  Number of steps during one week (pedometer)

I

  

X

  

X

 

X

C

X

   

X

 

X

  Self-reported global level of physical activity (QAPPA questionnaire)

I

  

X

   

X

  

X

C

 

X

    

X

  

X

  Frequency of consumption of 11 food families and of water/hot drinks (2 24-hour recalls + 1 FFQ)

I

X

X

   

X

X

 

X

X

C

X

X

   

X

X

 

X

X

  Quality of life (SF-12) + Feeling of loneliness (item from the FRAGIRE grid)

I

 

X

   

X

   

X

C

X

     

X

  

X

Secondary outcomes process evaluation

  Fidelity, dose, reach of the intervention (attendance lists, information sheets completed by the local organizations, dieticians and APA professionals after each session)

I

X

X

X

X

X

X

X

   

  Fidelity, dose of the intervention (questionnaire on self-reported exercises in daily activities, participation in post-session activities between participants)

I

      

X

  

X

  Mechanisms of the intervention (questionnaire on beliefs, attitudes, intention towards physical activity)

I

  

X

   

X

  

X

Cost-effectiveness evaluation

  Costs

I

X

X

X

X

X

X

X

X

  

C

X

X

X

X

X

X

X

X

  
  1. APA adapted physical activity, C control group, FFQ Food Frequency Questionnaire, I intervention group, S0-S6 diet and physical activity sessions of the ALAPAGE program, T0-T2 evaluation time points, V0-V3 measurement visits
  2. aLower limb muscle strength and other physical functions measured using the Senior Fitness Test battery are assessed at T0 and T2 but not at T1 because the interval time between T0 and T1 is too short to expect a significant impact of the intervention on these outcomes at T1