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Table 3 Content and time of data collections

From: Time-restricted eating (TRE) for obesity in general practice: study protocol of a controlled, randomized implementation study (INDUCT) within the Research Practice Network Baden-Wuerttemberg (FoPraNet-BW)

Point of time

Research tandem

Study participant

t-1

Week -1

Pre-screening

Data collection form (Study information and consent, participants age, participants sex, inclusion/exclusion criteria, blood sample, laboratory examination, study inclusion, randomization, documentation physical examination)

 

t0

Week 0

Study start

Data collection form practice (participants current health situationa)

• Study diaryb

• Self-developed Questionnaire (including sociodemographics, current health situation and previous weight management experiences)

• Standardized patient questionnaires***

Week 1

Data collection form Visit (IG only) (blood pressure, heart rate, parameters, other examination finds, (serious) adverse events, other aspects of the visit)

 

Week 2

Data collection form Visit (IG only) (blood pressure, heart rate, other examination finds, adverse events, other aspects of the visit)

 

Week 5

 

Study diaryb

Week 6

Data collection form Phone-Visit (IG only) (adverse events, other aspects of the visit)

 

Week 11

 

Study diaryb

t1

Week 12

Half-time visit

Data collection form practice (participants current health situationa, laboratory examination)

• Self-developed Questionnaire (including previous weight management experiences)

• Standardized patient questionnairesc

Week 17

 

Study diaryb

Week 23

 

Study diaryb

t2

Week 24

End of intervention

Data collection form practice (participants current health situationa, laboratory examination)

• Self-developed Questionnaire (including sociodemographics and previous weight management experiences)

• Standardized patient questionnairesc

t3

Week 48

Follow-up

Data collection form practice (participants current health situationa)

• Self-developed Questionnaire (including sociodemographics and previous weight management experiences)

• Standardized patient questionnairesc

  1. a The questionnaire about the participants current health situation contains current diseases, performed operations, current medications, current body mass index calculated from body weight and height, hip and abdominal circumference. At t1, t2 and t3 laboratory parameters are assessed (cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides, blood sugar, HbA1c, C-reactive protein, insulin)
  2. b Study diaries contain questions over 7 days about the current health situation, attitude towards time-restricted easting (IG only), the study, eating habits (CG only), time of the first and last meal a day, time-restricted eating (IG only), physical activity and a field for other feedback
  3. c The standardized patient questionnaires contain the German versions of the following standardized questionnaires: European Quality of Life 5 Dimensions 5 Level Version [23], World Health Organization-Five Well-Being Index [22], Pittsburgh Sleep Quality Index [24], Patient Activation Measure 13 [25], International Physically Activity Questionnaire [27], Body-Q [26], Nutritional pattern index [28])