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Table 1 Overview of measurements in the ACT trial

From: Lifestyle intervention to improve quality of life and prevent weight gain after renal transplantation: Design of the Active Care after Transplantation (ACT) randomized controlled trial

Outcome

Method

Time points

Quality of life

 

T0, T3, T6, T15

 Physical functioning

SF-36 PF subscale [72, 73]

 

 Other subdomains and total

SF-36 [72, 73]

 

 Renal specific

KDQOL-SF [39]

 

 General

EQ-5D [69]

 

Physical function

 Aerobic capacity

VO2peak ergometer test [74]

T0, T3, T6, T15

Sub-maximal ergometer test

T0, T3, T6, T15

 Muscle strength

1RM tests for leg extension, leg curl, chest press, close-grip pull-down

T0, T3, T6, T15

 Balance and mobility

Short Physical Performance Battery [41]

T0, T15

 Physical activity level

Baecke questionnaire [42]

T0, T3, T6, T15

 

Step counter (Yamax SW200) [75]

T0, T3, T6, T15

Body composition

 Weight, Height, WC, HC

WHO guidelines [76]

T0, T3, T6, T15

 Nutritional status (undernutrition)

SGA [77]

T0, T15

 Body fat percentage

BIA (Biostat Quadscan 4000, Douglas, Isle of Man)

T0, T3, T6, T15

 Muscle mass

BIA (Biostat Quadscan 4000, Douglas, Isle of Man)

T0, T3, T6, T15

24-h creatine excretion [44, 78]

T0, T3, T6, T15

Cardiometabolic risk factors

 Blood pressure

(Speidel & Keller Maxi Stabil 3)

T0, T3, T6, T15

 Blood lipids

TG, TC, HDL-C, LDL-C in fasting serum levels (Cholesterol oxidase-phenol aminophenazone method, MEGA AU 510; Merck Diagnostica, Darmstadt, Germany)

T0, T3, T6, T15

Glucose metabolism

 Insulin resistance

HOMA-IR (fasting glucose, insulin)

T0, T3, T15 (all)

 (Postprandial) hyperglycemia

7-point oral glucose tolerance test [47]

T0, T3, T15 (subgroup)

Renal parameters

 Medical history

Patient files

T0

 Renal function

eGFR, albuminuria

T0, T3, T6, T15

Medical history

Patients files

T0, T3, T6, T15

Medication

 Immunosuppressants

Patient files, plasma drug levels

T0, T3, T6, T15

 Other (e.g anti-hypertensives, anti-diabetics, statins)

Patient files

T0, T3, T6, T15

Psychological dimensions of lifestyle behavior

 Autonomy, competence, relatedness in general

Basic Needs Satisfaction in General Scale (BNSG [48, 49])

T0

 Autonomy, competence, relatedness in exercise

Basic Psychological Needs in Exercise Scale (BPNES [50])*

T3, T6, T15

 Self-regulation of exercise

Behavioral Regulation in Exercise Questionnaire (BREQ-2 [51])

T0, T3, T6, T15

 Self-regulation and autonomy

Treatment Self-Regulation Questionnaire (TSRQ [52])

T3, T6

 Motivation for exercise

Intrinsic Motivation Inventory (IMI [53]) adapted for exercise.

T3, T15

 Motives for exercise

Exercise Motivation Inventory (EMI-2 [54])

T0, T6

 Perceived competence

Perceived Competence Scale (PCS [56, 55])

T3, T6, T15

 Perceived autonomy support

Health Care Climate Questionnaire (HCCQ [55, 57])*

T3, T6, T15

 Fear of movement

Tampa Scale of Kinesiphobia – DV [58]

T0, T3, T15

Other questionnaires

 Demographics

Date of birth, marital status

T0, T3, T6, T15

Sex, education, ethnicity

T0

 Coping style

Utrecht Coping List [59]

T0

 Nutrition knowledge

Based on questions of national dietary guidelines survey

T0, T15

 Work-induced fatigue

Need for Recovery Scale (NFR [66])

T0, T3, T6, T15

 Chronic fatigue

Dutch Checklist Individual Resilience (CIS-20 [60,61,62])

T0, T3, T6, T15

 Work participation

NIVEL questionnaire [68]

T0, T3, T6, T15

Dietary intake

 Self-reported intake

3-day food diary

T0, T3, T6, T15

 Intake biomarkers

24-h excretion of sodium, potassium, urea

T0, T3, T6, T15

Smoking and alcohol consumption

Questionnaire

T0, T6, T15

Process evaluation

Questions about tools, coaches and the program for the patient*

Questions about tools, time/number of visits, and the program for the professional

Focus groups with patients*

Focus group with professionals

T15

Cost-effectiveness

 Quality of life

EQ-5D [69]

T0, T3, T6, T15

 Care consumption, intervention costs

Standard Dutch Questionnaire

T0, T3, T6, T9, T12, T15

  1. * These outcomes were only assessed in the intervention groups. Abbreviations: T#, months after baseline