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Table 1 Outcome measures, data collection methods and time points

From: Nutrition and physical activity intervention for families with familial hypercholesterolaemia: protocol for a pilot randomised controlled feasibility study

Study aim

Objectives being explored

Outcome measures

Data collection method/tool

Time point collected (weeks)

− 1

− 1 to 0

0

11–12

12

Primary: Feasibility and acceptability

1. Will young people and their parent be willing to participate in the proposed family-based intervention?

2. Will families accept randomisation to the control or intervention group, adhere to research methods in their allocated group and complete the study?

3. Are the research methods that are used to capture data fit for purpose?

Recruitment, retention, randomisation and adherence to protocol rates

Screening, recruitment and randomisation logs, monitoring of study visit attendance, successful collection of clinical outcome measures and withdraw/loss to follow up records.

Continuous during data collection period

4. Is there sufficient protocol fidelity in the intervention group?

Intervention intensity and adherence to intervention protocol and delivery

Self-completed checklists and recording of the number & duration of contact with participants

5. Upon completion of the study, was the overall experience of the intervention and/or the study research processes positive and potentially reproducible in an adequately powered trial?

Self-reported experiences and beliefs of participants regarding the study methodology &/or intervention

Semi-structured qualitative interviews

    

x

Secondary: Potential efficacy

No specific objectives stated for this secondary study aim

Patient characteristics: medication, education levels, smoking status and FH genetic variant

CRF developed for study

x

 

x

 

x

QoL score (HRQoL and component physical, emotional, social and school functioning scores for young people and single index value and VAS rating for adults)

Age appropriate PedsQLâ„¢ QoL inventory or EUROQOL 5D-3L health questionnaire

  

x

 

x

Mean fat, saturated fat, monounsaturated fat, polyunsaturated fat, fibre, plant sterol/stanols, cholesterol and fruit and vegetable intake per day (grams and % of daily energy intake)

INTAKE24 online dietary recall system completed for 4 days

 

x

 

x

 

MVPA (min/day)

ActiGraph GT3X+ accelerometer worn for 7 days

 

x

 

x

 

Time spent sitting/lying, standing and walking (min/day)

activPAL3 accelerometer worn for 7 days

 

x

 

x

 

Self-reported physical activity levels (MET minutes per week and categorised into high, medium or low level groups for adults and assigned score between 1 and 5 for young people, in which 1 indicates low levels and 5 high levels, of PA)

Age appropriate IPAQ, PAQ-A or PAQ-C questionnaire

 

x

 

x

 

Anthropometric measurements: height (cm), weight (kg), BMI (kg/m2), body composition including body fat (%) and fat free mass (%)

Tanita body composition analyser and stadiometer

  

x

 

x

Systolic and diastolic blood pressure (mmHg)

Mean of two measures by a sphygmomanometer (three measures if 1st and 2nd differ by more than 10mmHg)

  

x

 

x

Serum concentrations (mmol/l) and component lipid breakdown (mmol/l and %) of different classes (very large, large, medium and small) of VLDL, LDL, HDL particles; mean diameter of VLDL, LDL & HDL particles (nm); serum concentration of total cholesterol, LDL, HDL, HDL2, HDL3, remnant cholesterol, triglycerides (mmol/l) and Apolipoproteins (g/l).

Metabolomic analysis of serum samples obtained from processing of 25ml whole blood samples

  

x

 

x

  1. CRF case report form, QoL quality of life, VAS visual analogue scale, MVPA moderate-to-vigorous physical activity, IPAQ International Physical Activity Questionnaire, PAQ-A the Physical Activity Questionnaire for Adolescents, PAQ-C the Physical Activity Questionnaire for older Children, BMI body mass index, VLDL very large density lipoprotein, LDL low-density lipoprotein, HDL high-density lipoprotein