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. 2022 Jul 28;11(7):e37556. doi: 10.2196/37556

Table 2.

Primary and secondary outcomes and their associated measurements.

Outcomes Measurements
Primary outcomes

Safety
  • Number of study-related serious adverse events


Recruitment rate
  • Number of patients recruited as a proportion of all referred eligible patients


Retention
  • Number of intervention participants undergoing end-of-program assessment


Exposure uptake
  • Frequency of dietetic and exercise specialist contact (within public hospital system) as a proportion of total scheduled contacts


Telehealth adherence
  • Attendance to online exercise and dietetic sessions as a proportion of total scheduled contacts

Secondary outcomes

Clinical effectiveness


Metabolic Syndrome Severity Score [31]
  • Algorithm score comprising systolic blood pressure, diastolic blood pressure, waist circumference, triglycerides, high-density lipoprotein cholesterol, and fasting blood glucose



Dietary quality
  • Diet quality assessed by food group intake (frequency per day or week), fiber intake (grams per day), unsaturated oils (grams per day), and discretionary food intake (grams per day)



Physical activity and sedentary behavior
  • Time (intensity-weighted minutes) spent in past week as assessed by International Physical Activity Questionnaire (Short Form) and Fitbit weekly physical activity heart rate data



Exercise capacity
  • 6-Minute Walk Test score



Neuromuscular fitness
  • Single chair stand, Five Times Sit to Stand test, hand grip strength



Muscular pain
  • Modified Nordic Musculoskeletal Questionnaire



Quality of life
  • European Quality of Life Five Dimension Five Level Scale



Nutrition and physical activity management self-efficacy
  • Likert confidence scales



Fatigue
  • Functional Assessment of Chronic Illness Fatigue Scale score



Sleep quality and quantity
  • Pittsburgh Sleep Quality Index score, total Fitbit weekly sleep data



Additional clinical parameters

Goal attainment
  • Goal Attainment Scale score


Treatment fidelity
  • Treatment notesa

  • Staff attendance at professional support and case discussions


Exposure demand
  • Selection of health technology options


Participant perceptions
  • Feedback survey

  • Qualitative individual interview data (subsample)

aParticipant session notes taken by health professionals from telehealth-facilitated sessions with the intervention group.