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NCT Number: NCT06122441

RE-inventing Strategies for Healthy Ageing; Recommendations and Tools

The goal of the RESTART RCT is to examine whether a complex lifestyle intervention, coordinated with municipal and non-government organizations (NGO), can establish and preserve improvements in risk factors and functional capacity among older adults at high risk of cardiometabolic disease. The main objectives to investigate are whether a complex lifestyle intervention, compared to an active control group, will at 24 months have:

1. Produced a clinically relevant increase in cardiorespiratory fitness (primary endpoint) 2. Increased muscle strength, physical activity and reduced adiposity 3. Improved body composition, health-related quality of life and cognitive function

All participants (Control and Intervention Groups) are provided with wrist-worn activity trackers at baseline and access to national recommendations on physical activity. The intervention group additionally advances through a comprehensive lifestyle program including high-intensity aerobic and strength exercise, dietary and behavioral counselling. Intervention participants are gradually transitioned into exercise activities organized by Tromsø Municipaity and local NGO:s. Testing of outcomes are performed at baseline, 6, 12 and 24 months. Primary endpoint (VO2max) is assessed at 24 months.

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Key information

Conditions

Lifestyle, Healthy Abdominal Obesity Behavior Body Weight Cardiometabolic Syndrome Diet, Healthy Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Motor Activity Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Self Efficacy Signs and Symptoms

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UiT The Arctic University of Norway

Tromsø, Troms, 9018, Norway

About this study

The proportion of older individuals worldwide is growing, posing a significant challenge to western societies. To address the health challenges of the aging population, primary prevention efforts should focus on various lifestyle factors simultaneously. However, many interventions fail to maintain improved lifestyle habits among participants, highlighting the need for novel and complex approaches to ensure healthy aging among older adults.

The RESTART randomized controlled trial aims to investigate whether participants undergoing a complex lifestyle intervention improve their cardiorespiratory fitness, muscle strength, physical activity, adiposity and body composition, quality of life and cognitive function at 24 months, compared to active controls.

The study and data collection will occur in Tromsø, Norway (pop. 77,000). Participants will receive the intervention at a local community exercise center near the University of Tromsø campus area. Testing of physical performance will take place at the UiT Faculty of Health Sciences research laboratory for sports, physical activity, and public health. The Clinical Trial Unit (CTU) at the local university hospital will additionally oversee clinical examinations, collection of questionnaire data, and blood sampling.

At baseline, both the Control and Intervention Groups are given wrist-worn activity trackers and access to national physical activity recommendations. The Intervention Group also undergoes a comprehensive lifestyle program that includes high-intensity aerobic and strength exercises, as well as dietary and behavioral counseling. The Intervention Group is gradually introduced to exercise activities organized by Tromsø Municipality and local NGOs. Outcome testing is conducted at baseline, 6, 12, and 24 months, with the primary endpoint (VO2max) assessed at 24 months.

Intervention participants will be divided into 4 groups of 12-15 participants each and perform high-intensity training to target the cardiovascular system and skeletal muscle force-generating capacity. For 12 months, the intervention group performs supervised indoor cycling or outdoor hill interval training twice a week at a relatively high intensity (≥85% of maximal heart rate during 4x4 minutes) separated by active rest periods at approximately 70% of maximal heart rate. Immediately after the aerobic exercise, participants perform strength training (3 sets of 5 repetitions) involving leg-press, lateral pull-down, and chest press exercises, with an intensity corresponding to ≥80% of their maximal strength. From months 6-12, one of the two weekly exercise sessions will be led by the Healthy Life Center (HLC; "Frisklivssentralen"), enabling a transition to supervised exercise via the Tromsø municipality primary health care. Between month 12-18, the HLC continue to supervise the participants during one weekly exercise sessions, while they are additionally introduced to exercise activities arranged by local NGO:s.

From month 3 to 12, participants will receive behavioral counseling based on the Acceptance and Commitment Therapy (ACT) approach during six 2-hour group sessions. The individual approach aims to enhance participants' capacity to manage challenging cognitive and emotional experiences, foster psychological flexibility and distress tolerance skills, and promote the development of self-efficacy and new behavior patterns that align with their life values.

From month 6 to 12, the intervention group will receive four dietary counseling sessions based on Norwegian nutritional guidelines. Two individual sessions will involve food diaries, while two group sessions with a partner will focus on basic nutritional information and practical food preparation. The objective is to promote a healthy, sustainable, and personalized diet while promoting increased protein intake, reducing the consumption of high-energy-dense foods and drinks with low nutritional value.

Beginning from month 12 and onwards throughout the trial, the intervention group will be granted access to the Re-start eTool (https://re-start.no/), which is specifically tailored to older adults. The eTool offers concise and easy-to-understand articles, videos, and self-assessment tools that promote physical activity, healthy dietary habits, and behavioral strategies from the complex intervention. The Re-start eTool aims to provide support and reminders to participants as they gradually transition to independently maintaining the achieved lifestyle habits and physical capacity levels.

Throughout the study period, the intervention instructors and assessors monitor potential adverse events during the exercise and testing phases, and all adverse events are reported to the study coordinator. Measures to mitigate adverse events include: 1) insurance of participants via The Norwegian System of Patient Injury Compensation; 2) involving a MD with sports medicine specialization to ensure treatment of potential injuries; 3) pilot study experiences show that short-term alternative exercises are effective in managing exercise-induced pain and discomfort.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 60-75 years
  • BMI ≥ 30 kg/m2
  • Elevated CVD-risk (Score 8/12 on the NORRISK 2 model)
  • Sedentary lifestyle (Score "1" on the Saltin-Grimby Physical Activity Level Scale)

Exclusion criteria

  • Presence of dementia diagnosis
  • Self-reported previous myocardial infarction or stroke, and/or self-reported established cardiovascular disease by presence of coronary stent
  • Heart failure with ejection fraction <50%
  • Electrocardiogram ECG presenting with atrioventricular block grade 2 type 2 or grade 3, or previous myocardial infarction.
  • Uncontrolled hypertension (systolic blood pressure≥180 mmHg and/or diastolic blood pressure≥110 mmHg unless cleared by a nephrologist)
  • Chronic obstructive pulmonary disease grade 3 or 4
  • Thyroid dysfunction (thyroxine <7 pmol/L and thyroid-stimulating hormone >10 mIU/L, and/or thyroxine >25 pmol/L and thyroid-stimulating hormone <0.2 mIU/L)
  • Liver dysfunction (alanine aminotransferase >210 µmol/L for men, >135 µmol/L for women, and/or aspartate aminotransferase >135 µmol/L for men, >105 µmol/L for women, and/or alkaline phosphatase >345 µmol/L)
  • Kidney dysfunction (creatinine >220 µmol/L), in addition to prognosis of CKD by GFR and Albuminuria KDIGO 2012 algorithm
  • Severe anemia (hemoglobin <10g/dL for men, <8g/dL for women)
  • Uncontrolled diabetes (glycated hemoglobin ≥86 mmol/mol)
  • Severe hearing problems
  • Severe mobility limitations (unable to get up from a sitting or lying position, unable to maintain a crouched position, unable to raise arms above shoulder or head height)
  • No possession of a smartphone
  • No access to the Norwegian national identification service (BankID)
  • Unable to follow the trial regimen for 24 months

Treatment and study plan

Complex lifestyle intervention

Behavioral

The complex lifestyle intervention comprise high-intensity aerobic and strength exercise, behavioral counselling based on Acceptance and Commitment Theory (ACT), and dietary counselling based on Norwegian nutritional guidelines. The different intervention elements are introduced step-wise to reduce initial overload. Participants are progressively transitioned over to the Tromsø municipality and local NGO's, who delivers activities harmonized with the intervention elements. Participants are at this stage also supported by an eTool which digitally reinforces the intervention through web-based information and videos.

Physical activity monitoring and recommendations

Behavioral

Wrist-worn activity trackers that are worn throughout the trial, which monitors steps, activity intensity and energy expenditure. Access to Norwegian physical activity guidelines via the Directorate of Health.

Primary outcomes

  1. Change from baseline in VO2max at month 24

    Time frame: Baseline and month 24

    Assessed as ml/kg/min during an incremental test-to-exhaustion where the participant walks or runs on a motorized treadmill.

  2. Change from baseline in VO2max at month 12

    Time frame: Baseline and month 12

    Assessed as ml/kg/min during an incremental test-to-exhaustion where the participant walks or runs on a motorized treadmill.

  3. Change from baseline in VO2max at month 6

    Time frame: Baseline and month 6

    Assessed as ml/kg/min during an incremental test-to-exhaustion where the participant walks or runs on a motorized treadmill.

Secondary outcomes

  1. Change from baseline in muscle strength at month 24

    Time frame: Baseline and month 24

    Assessed as the highest kg achieved during a 1-repetition maximum test in leg-press and chest-press apparatuses.

  2. Change from baseline in muscle strength at month 12

    Time frame: Baseline and month 12

    Assessed as the highest kg achieved during a 1-repetition maximum test in leg-press and chest-press apparatuses.

  3. Change from baseline in muscle strength at month 6

    Time frame: Baseline and month 6

    Assessed as the highest kg achieved during a 1-repetition maximum test in leg-press and chest-press apparatuses.

  4. Change from baseline in muscle power at month 24

    Time frame: Baseline and month 24

    Assessed as power (W; force x speed of contraction) during leg-press exercise with pre-defined weight ascertained during baseline measurements

  5. Change from baseline in muscle power at month 12

    Time frame: Baseline and month 12

    Assessed as power (W; force x speed of contraction) during leg-press exercise with pre-defined weight ascertained during baseline measurements

  6. Change from baseline in muscle power at month 6

    Time frame: Baseline and month 6

    Assessed as power (W; force x speed of contraction) during leg-press exercise with pre-defined weight ascertained during baseline measurements

  7. Change from baseline in waist circumference at month 24

    Time frame: Baseline and month 24

    Assessed in centimeters at the umbilical level (between crista iliaca and the lower rib) using a measurement tape.

  8. Change from baseline in waist circumference at month 12

    Time frame: Baseline and month 12

    Assessed in centimeters at the umbilical level (between crista iliaca and the lower rib) using a measurement tape.

  9. Change from baseline in waist circumference at month 6

    Time frame: Baseline and month 6

    Assessed in centimeters at the umbilical level (between crista iliaca and the lower rib) using a measurement tape.

  10. Change from baseline in body weight at month 24

    Time frame: Baseline and month 24

    Assessed in kilograms using a SECA personal weight. Participants are measured without outdoor clothing and shoes.

  11. Change from baseline in body weight at month 12

    Time frame: Baseline and month 12

    Assessed in kilograms using a SECA personal weight. Participants are measured without outdoor clothing and shoes.

  12. Change from baseline in body weight at month 6

    Time frame: Baseline and month 6

    Assessed in kilograms using a SECA personal weight. Participants are measured without outdoor clothing and shoes.

  13. Change from baseline in minutes in moderate-to-vigorous physical activity per day at month 24

    Time frame: Baseline and month 24

    Assessed as minutes in light, moderate and vigorous intensity, using triaxial accelerometers worn at the hip for 7 days.

  14. Change from baseline in minutes in moderate-to-vigorous physical activity per day at month 12

    Time frame: Baseline and month 12

    Assessed as minutes in light, moderate and vigorous intensity, using triaxial accelerometers worn at the hip for 7 days.

  15. Change from baseline in minutes in moderate-to-vigorous physical activity per day at month 6

    Time frame: Baseline and month 6

    Assessed as minutes in light, moderate and vigorous intensity, using triaxial accelerometers worn at the hip for 7 days.

  16. Daily physical activity pattern

    Time frame: 24 months

    Asessed using wrist-worn smartwatches that are worn by the participants continously and measures steps, activity intensity and energy expenditure

Other outcomes

  1. Change from baseline in relative body composition at month 24

    Time frame: Baseline and month 24

    Assessed as percentage fat and lean mass in relation to total body mass using Dual-Energy X-ray Absorptiometry

  2. Change from baseline in relative body composition at month 12

    Time frame: Baseline and month 12

    Assessed as percentage fat and lean mass in relation to total body mass using Dual-Energy X-ray Absorptiometry

  3. Change from baseline in absolute body composition at month 24

    Time frame: Baseline and month 24

    Assessed as fat/lean/bone mass in grams using Dual-Energy X-ray Absorptiometry

  4. Change from baseline in absolute body composition at month 12

    Time frame: Baseline and month 12

    Assessed as fat/lean/bone mass in grams using Dual-Energy X-ray Absorptiometry

  5. Change from baseline in health-related quality of life at month 24

    Time frame: Baseline and month 24

    Assessed with a 5-point likert scale in 5 different dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) using the EQ-5D-5L instrument

  6. Change from baseline in health-related quality of life at month 12

    Time frame: Baseline and month 12

    Assessed with a 5-point likert scale in 5 different dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) using the EQ-5D-5L instrument

  7. Change from baseline in cognitive function using the Digit Symbol Substitution Test at month 24

    Time frame: Baseline and month 24

    Assessed as the number of symbols correctly matched with numbers within the allowed time

  8. Change from baseline in cognitive function using the Digit Symbol Substitution Test at month 12

    Time frame: Baseline and month 12

    Assessed as the number of symbols correctly matched with numbers within the allowed time

  9. Change from baseline in forced expiratory volume (FEV1) at month 24

    Time frame: Baseline and month 24

    Assessed as litres/sec using the Micro 1 Spirometer with participants exhaling maximally for six seconds during three attempts with 30 seconds of rest in between.

  10. Change from baseline in forced vital capacity (FVC) at month 24

    Time frame: Baseline and month 24

    Assessed as litres using the Micro 1 Spirometer with participants exhaling maximally for six seconds during three attempts with 30 seconds of rest in between.

  11. Change from baseline in peak expiratory flow (PEF) at month 24

    Time frame: Baseline and month 24

    Assessed as litres/min using the Micro 1 Spirometer with participants exhaling maximally for six seconds during three attempts with 30 seconds of rest in between.

  12. Change from baseline in resting heart rate at month 24

    Time frame: Baseline and month 24

    Assessed as beats per minute three times in 1-minute intervals after an initial 2-minute rest

  13. Change from baseline in resting heart rate at month 12

    Time frame: Baseline and month 12

    Assessed as beats per minute three times in 1-minute intervals after an initial 2-minute rest

  14. Change from baseline in resting heart rate at month 6

    Time frame: Baseline and month 6

    Assessed as beats per minute three times in 1-minute intervals after an initial 2-minute rest

  15. Change from baseline in systolic and diastolic blood pressure at month 24

    Time frame: Baseline and month 24

    Assessed as mmHg three times in 1-minute intervals after an initial 2-minute rest

  16. Change from baseline in systolic and diastolic blood pressure at month 12

    Time frame: Baseline and month 12

    Assessed as mmHg three times in 1-minute intervals after an initial 2-minute rest

  17. Change from baseline in systolic and diastolic blood pressure at month 6

    Time frame: Baseline and month 6

    Assessed as mmHg three times in 1-minute intervals after an initial 2-minute rest

  18. Change from baseline in hand-held dynamometer-derived maximal handgrip strength at month 24

    Time frame: Baseline and month 24

    Assessed in kg and performed according to the Southampton protocol

  19. Change from baseline in hand-held dynamometer-derived maximal handgrip strength at month 12

    Time frame: Baseline and month 12

    Assessed in kg and performed according to the Southampton protocol

  20. Change from baseline in 5-repetition chair stand test performance at month 24

    Time frame: Baseline and month 24

    Assessed as time (s) to complete 5 consecutive chair rises, using the 5-repetition chair stand test according to the Short Physical Performance Battery protocol

  21. Change from baseline in 5-repetition chair stand test performance at month 12

    Time frame: Baseline and month 12

    Assessed as time (s) to complete 5 consecutive chair rises, using the 5-repetition chair stand test according to the Short Physical Performance Battery protocol

  22. Change from baseline in satisfaction with life at month 24

    Time frame: Baseline and month 24

    Assessed with a 7-point likert scale using the 5-item Satisfaction With Life Scale (SWLS)

  23. Change from baseline in satisfaction with life at month 12

    Time frame: Baseline and month 12

    Assessed with a 7-point likert scale using the 5-item Satisfaction With Life Scale (SWLS)

  24. Change from baseline in mental distress on the 10-item Hopkins Symptom Checklist (HSCL-5) at month 24

    Time frame: Baseline and month 24

    Assessed with a 5-point likert scale using the 10-item Hopkins Symptom Checklist (HSCL-5)

  25. Change from baseline in mental distress on the 10-item Hopkins Symptom Checklist (HSCL-5) at month 12

    Time frame: Baseline and month 12

    Assessed with a 5-point likert scale using the 10-item Hopkins Symptom Checklist (HSCL-5)

  26. Change from baseline in physical activity discomfort and acceptance on the 10-item Physical Activity Acceptance Questionnaire (PAAQ) at month 24

    Time frame: Baseline and month 24

    Assessed with a 7-point likert scale using the 10-item Physical Activity Acceptance Questionnaire (PAAQ)

  27. Change from baseline in physical activity discomfort and acceptance on the 10-item Physical Activity Acceptance Questionnaire (PAAQ) at month 12

    Time frame: Baseline and month 12

    Assessed with a 7-point likert scale using the 10-item Physical Activity Acceptance Questionnaire (PAAQ)

  28. Change from baseline in physical activity enjoyment on the 4-item Physical Activity Enjoyment Scale Short Form (PACES-S) at month 24

    Time frame: Baseline and month 24

    Assessed with a 4-point likert scale using the 4-item Physical Activity Enjoyment Scale Short Form (PACES-S)

  29. Change from baseline in physical activity enjoyment on the 4-item Physical Activity Enjoyment Scale Short Form (PACES-S) at month 12

    Time frame: Baseline and month 12

    Assessed with a 4-point likert scale using the 4-item Physical Activity Enjoyment Scale Short Form (PACES-S)

  30. Change from baseline in emotional eating on the 3-item Emotional Eating Subscale from the Three-Factor Eating Questionnaire (TFEQ) at month 24

    Time frame: Baseline and month 24

    Assessed with a 4-point likert scale using the 3-item Emotional Eating Subscale from the Three-Factor Eating Questionnaire (TFEQ)

  31. Change from baseline in emotional eating on the 3-item Emotional Eating Subscale from the Three-Factor Eating Questionnaire (TFEQ) at month 12

    Time frame: Baseline and month 12

    Assessed with a 4-point likert scale using the 3-item Emotional Eating Subscale from the Three-Factor Eating Questionnaire (TFEQ)

  32. Change from baseline in binge eating episodes on the Eating Disorder Examination (EDE) questionnaire at month 24

    Time frame: Baseline and month 24

    Assessed with a 7-point likert scale using the item on binge eating episodes from the Eating Disorder Examination (EDE) questionnaire

  33. Change from baseline in binge eating episodes on the Eating Disorder Examination (EDE) questionnaire at month 12

    Time frame: Baseline and month 12

    Assessed with a 7-point likert scale using the item on binge eating episodes from the Eating Disorder Examination (EDE) questionnaire

  34. Change from baseline in intuitive eating on the 6-item Reliance on Internal Hunger and Satiety Cues Subscale from the Intuitive Eating Scale (IES) at month 24

    Time frame: Baseline and month 24

    Assessed with a 5-point likert scale using the 6-item Reliance on Internal Hunger and Satiety Cues Subscale from the Intuitive Eating Scale (IES)

  35. Change from baseline in intuitive eating on the 6-item Reliance on Internal Hunger and Satiety Cues Subscale from the Intuitive Eating Scale (IES) at month 12

    Time frame: Baseline and month 12

    Assessed with a 5-point likert scale using the 6-item Reliance on Internal Hunger and Satiety Cues Subscale from the Intuitive Eating Scale (IES)

  36. Change from baseline in self-efficacy on the 10-item General Self-Efficacy Scale (GSE) at month 24

    Time frame: Baseline and month 24

    Assessed with a 4-point likert scale using the 10-item General Self-Efficacy Scale (GSE)

  37. Change from baseline in self-efficacy on the 10-item General Self-Efficacy Scale (GSE) at month 12

    Time frame: Baseline and month 12

    Assessed with a 4-point likert scale using the 10-item General Self-Efficacy Scale (GSE)

  38. Change from baseline in self-compassion on the 6-item Self-Compassion Scale at month 24

    Time frame: Baseline and month 24

    Assessed with a 5-point likert scale using the 6-item Self-Compassion Scale

  39. Change from baseline in self-compassion on the 6-item Self-Compassion Scale at month 12

    Time frame: Baseline and month 12

    Assessed with a 5-point likert scale using the 6-item Self-Compassion Scale

  40. Change from baseline in self-reported education status at month 24

    Time frame: Baseline and month 24

    Assessed using 4 alternatives (from elementary school to college/university) using the education status question from a standardized comprehensive questionnaire from the 7th data collection wave of the Tromsø Study (2015-2016)

  41. Change from baseline in self-reported household income at month 24

    Time frame: Baseline and month 24

    Assessed with a 8-point likert scale using the household income question from a standardized comprehensive questionnaire from the 7th data collection wave of the Tromsø Study (2015-2016)

  42. Change from baseline in self-reported occupation status at month 24

    Time frame: Baseline and month 24

    Assessed with 9 nominal alternatives without intrinsic order using the occupation status question from a standardized comprehensive questionnaire from the 7th data collection wave of the Tromsø Study (2015-2016)

  43. Change from baseline in self-reported occupation status at month 12

    Time frame: Baseline and month 12

    Assessed with 9 nominal alternatives without intrinsic order using the occupation status question from a standardized comprehensive questionnaire from the 7th data collection wave of the Tromsø Study (2015-2016)

  44. Change from baseline in self-reported occupation status at month 6

    Time frame: Baseline and month 6

    Assessed with 9 nominal alternatives without intrinsic order using the occupation status question from a standardized comprehensive questionnaire from the 7th data collection wave of the Tromsø Study (2015-2016)

  45. Change from baseline in self-reported ideal weight at month 24

    Time frame: Baseline and month 24

    Assessed using a 5-item questionnaire on ideal weight combining 2 dichotomous (yes/no) scales and 3 continuous scales. This questionnaire was developed as part of the comprehensive standardized questionnaire used in the 7th data collection wave of the Tromsø Study (2015-2016).

  46. Change from baseline in self-reported ideal weight at month 12

    Time frame: Baseline and month 12

    Assessed using a 5-item questionnaire on ideal weight combining 2 dichotomous (yes/no) scales and 3 continuous scales. This questionnaire was developed as part of the comprehensive standardized questionnaire used in the 7th data collection wave of the Tromsø Study (2015-2016).

  47. Change from baseline in self-reported chronic disease at month 24

    Time frame: Baseline and month 24

    Assessed using a 11-item questionnaire with each item including a 3-point ordinal scale response option (no, yes-previously, yes-now). This questionnaire was developed as part of the comprehensive standardized questionnaire used in the 7th data collection wave of the Tromsø Study (2015-2016).

  48. Change from baseline in self-reported chronic disease at month 12

    Time frame: Baseline and month 12

    Assessed using a 11-item questionnaire with each item including a 3-point ordinal scale response option (no, yes-previously, yes-now). This questionnaire was developed as part of the comprehensive standardized questionnaire used in the 7th data collection wave of the Tromsø Study (2015-2016).

  49. Change from baseline in self-reported symptoms and complaints at month 24

    Time frame: Baseline and month 24

    Assessed using a 10-item questionnaire including 8 items with dichotomous response alternatives and 6 items with ordinal scale response alternatives. This questionnaire was developed as part of the comprehensive standardized questionnaire used in the 7th data collection wave of the Tromsø Study (2015-2016).

  50. Change from baseline in self-reported symptoms and complaints at month 12

    Time frame: Baseline and month 12

    Assessed using a 10-item questionnaire including 7 items with dichotomous response alternatives and 3 items with ordinal scale response alternatives. This questionnaire was developed as part of the comprehensive standardized questionnaire used in the 7th data collection wave of the Tromsø Study (2015-2016).

  51. Change from baseline in self-reported medicine use at month 24

    Time frame: Baseline and month 24

    Assessed using a 9-item questionnaire including 8 items with ordinal scale response alternatives and 1 item with free text response alternative to list currently used medicine. This questionnaire was developed as part of the comprehensive standardized questionnaire used in the 7th data collection wave of the Tromsø Study (2015-2016).

  52. Change from baseline in self-reported medicine use at month 12

    Time frame: Baseline and month 12

    Assessed using a 9-item questionnaire including 8 items with ordinal scale response alternatives and 1 item with free text response alternative to list currently used medicine. This questionnaire was developed as part of the comprehensive standardized questionnaire used in the 7th data collection wave of the Tromsø Study (2015-2016).

  53. Change from baseline in self-reported medicine use at month 6

    Time frame: Baseline and month 6

    Assessed using a 9-item questionnaire including 8 items with ordinal scale response alternatives and 1 item with free text response alternative to list currently used medicine. This questionnaire was developed as part of the comprehensive standardized questionnaire used in the 7th data collection wave of the Tromsø Study (2015-2016).

  54. Change from baseline in self-reported social network at month 24

    Time frame: Baseline and month 24

    Assessed using a 4-item questionnaire including 3 items with nominal scale response alternatives and 1 item with ordinal scale response alternative. This questionnaire was developed as part of the comprehensive standardized questionnaire used in the 7th data collection wave of the Tromsø Study (2015-2016).

  55. Change from baseline in self-reported social network at month 12

    Time frame: Baseline and month 12

    Assessed using a 4-item questionnaire including 3 items with nominal scale response alternatives and 1 item with ordinal scale response alternative. This questionnaire was developed as part of the comprehensive standardized questionnaire used in the 7th data collection wave of the Tromsø Study (2015-2016).

  56. Change from baseline in self-reported tobacco use at month 24

    Time frame: Baseline and month 24

    Assessed using a 2-item questionnaire including ordinal scale response alternatives (never, yes-previously, yes-now). This questionnaire was developed as part of the comprehensive standardized questionnaire used in the 7th data collection wave of the Tromsø Study (2015-2016).

  57. Change from baseline in self-reported tobacco use at month 12

    Time frame: Baseline and month 12

    Assessed using a 2-item questionnaire including ordinal scale response alternatives (never, yes-previously, yes-now). This questionnaire was developed as part of the comprehensive standardized questionnaire used in the 7th data collection wave of the Tromsø Study (2015-2016).

  58. Change from baseline in self-reported alcohol use at month 24

    Time frame: Baseline and month 24

    Assessed using a 3-item questionnaire with ordinal scale response alternatives. This questionnaire was developed as part of the comprehensive standardized questionnaire used in the 7th data collection wave of the Tromsø Study (2015-2016).

  59. Change from baseline in self-reported alcohol use at month 12

    Time frame: Baseline and month 12

    Assessed using a 3-item questionnaire with ordinal scale response alternatives. This questionnaire was developed as part of the comprehensive standardized questionnaire used in the 7th data collection wave of the Tromsø Study (2015-2016).

  60. Change from baseline in self-rated health at month 24

    Time frame: Baseline and month 24

    Assessed using a 2-item questionnaire with 5-point ordinal scale response alternatives. This questionnaire was developed as part of the comprehensive standardized questionnaire used in the 7th data collection wave of the Tromsø Study (2015-2016).

  61. Change from baseline in self-rated health at month 12

    Time frame: Baseline and month 12

    Assessed using a 2-item questionnaire with 5-point ordinal scale response alternatives. This questionnaire was developed as part of the comprehensive standardized questionnaire used in the 7th data collection wave of the Tromsø Study (2015-2016).

  62. Change from baseline in self-reported leisure time physical activity level at month 24

    Time frame: Baseline and month 24

    Assessed using the 4-item Saltin-Grimby Physical Activity Level Scale

  63. Change from baseline in self-reported leisure time physical activity level at month 12

    Time frame: Baseline and month 12

    Assessed using the 4-item Saltin-Grimby Physical Activity Level Scale

  64. Change from baseline in self-reported diet using the NORKOST Food Frequency Questionnaire at month 24

    Time frame: Baseline and month 24

    Assessed using the Norwegian NORKOST Food Frequency Questionnaire including 274 items on various food groups and specific foods

  65. Change from baseline in self-reported diet using the NORKOST Food Frequency Questionnaire at month 12

    Time frame: Baseline and month 12

    Assessed using the Norwegian NORKOST Food Frequency Questionnaire including 274 items on various food groups and specific foods

  66. Change from baseline in hemoglobin (Hb) and glycated hemoglobin (HbA1C) at month 24

    Time frame: Baseline and month 24

    Assessed as % using non-fasted blood samples analysed with high-performance liquid chromatography

  67. Change from baseline in hemoglobin (Hb) and glycated hemoglobin (HbA1C) at month 12

    Time frame: Baseline and month 12

    Assessed as % using non-fasted blood samples analysed with high-performance liquid chromatography

  68. Change from baseline in hemoglobin (Hb) and glycated hemoglobin (HbA1C) at month 6

    Time frame: Baseline and month 6

    Assessed as % using non-fasted blood samples analysed with high-performance liquid chromatography

  69. Change from baseline in blood lipids (total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides) at month 24

    Time frame: Baseline and month 24

    Assessed as mmol/l using non-fasted blood samples analysed with colorimetric (Homogen, or homogen enzymatic) methods

  70. Change from baseline in blood lipids (total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides) at month 12

    Time frame: Baseline and month 12

    Assessed as mmol/l using non-fasted blood samples analysed with colorimetric (Homogen, or homogen enzymatic) methods

  71. Change from baseline in blood lipids (total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides) at month 6

    Time frame: Baseline and month 6

    Assessed as mmol/l using non-fasted blood samples analysed with colorimetric (Homogen, or homogen enzymatic) methods

  72. Change from baseline in renal function markers (cystatin C, creatinine) at month 24

    Time frame: Baseline and month 24

    Collected as non-fasting venous blood samples using standard methods

  73. Change from baseline in renal function markers (cystatin C, creatinine) at month 12

    Time frame: Baseline and month 12

    Collected as non-fasting venous blood samples using standard methods

  74. Change from baseline in renal function markers (cystatin C, creatinine) at month 6

    Time frame: Baseline and month 6

    Collected as non-fasting venous blood samples using standard methodsdescribed

  75. Baseline levels of markers of thyroid function (thyroxin, thyroid-stimulating hormone)

    Time frame: Baseline

    Collected as non-fasting venous blood samples using standard methods. Used primarily as a potential exclusion criteria.

  76. Change from baseline in liver enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase) at month 24

    Time frame: Baseline and month 24

    Collected as non-fasting venous blood samples using standard methods

  77. Change from baseline in liver enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase) at month 12

    Time frame: Baseline and month 12

    Collected as non-fasting venous blood samples using standard methods

  78. Change from baseline in phosphatidylethanol at month 24

    Time frame: Baseline and month 24

    Collected as a non-fasting venous blood sample using standard methods in order to monitor alcohol consumption

  79. Change from baseline in phosphatidylethanol at month 12

    Time frame: Baseline and month 12

    Collected as a non-fasting venous blood sample using standard methods in order to monitor alcohol consumption

  80. Change from baseline in testosterone at month 24

    Time frame: Baseline and month 24

    Collected as a non-fasting venous blood sample using standard methods

  81. Change from baseline in testosterone at month 12

    Time frame: Baseline and month 12

    Collected as a non-fasting venous blood sample using standard methods

  82. Change from baseline in C-reactive protein at month 24

    Time frame: Baseline and month 24

    Collected as a non-fasting venous blood sample using standard methods

  83. Change from baseline in C-reactive protein at month 12

    Time frame: Baseline and month 12

    Collected as a non-fasting venous blood sample using standard methods

  84. Change from baseline in albumin-creatinine ratio at month 24

    Time frame: Baseline and month 24

    Collected as a morning urine sample using standard methods

  85. Change from baseline in albumin-creatinine ratio at month 12

    Time frame: Baseline and month 12

    Collected as a morning urine sample using standard methods

  86. Change from baseline in albumin-creatinine ratio at month 6

    Time frame: Baseline and month 6

    Collected as a morning urine sample using standard methods

  87. Change from baseline in ECG PQ-interval at month 24

    Time frame: Baseline and month 24

    Assessed in milliseconds using a 12-point electrocardiogram (ECG) to evaluate the time interval from the beginning of the P wave to the beginning of the QRS complex, to establish atrioventricular block (grade 1-3)

  88. Change from baseline in ECG P-wave at month 24

    Time frame: Baseline and month 24

    Assessed in milliseconds using a 12-point electrocardiogram (ECG) to evaluate the atrial depolarization, and used to determine cardiac rhythm disturbance (atrial fibrillation)

  89. Change from baseline in ECG QRS-complex at month 24

    Time frame: Baseline and month 24

    Assessed in milliseconds using a 12-point electrocardiogram (ECG) to evaluate the characterization of the QRS-complex to determine ventricular tachycardia

  90. Change from baseline in ECG T-wave at month 24

    Time frame: Baseline and month 24

    Assessed in millivolts using a 12-point electrocardiogram (ECG) to determine T-wave inversion in V3-6 (negative from baseline)

  91. Participants' experiences of receiving a complex lifestyle intervention

    Time frame: 24 months

    Assessed using qualitative semi-structured interviews to provide a more comprehensive understanding of participants' experiences and motivation during the trial, and to find potential important determinants of lifestyle change. Qualitative data will be structured with the QRS NVivo software, and analyzed with content- or thematic analyses.

  92. Assessment of the cost-effectiveness of receiving the intervention versus not receiving the intervention, over a 24-month period

    Time frame: 24 months

    Data on resource use will be collected during the trial to facilitate health economic evaluation of the personalized lifestyle program. The trial has already mentioned collection of data on health-related quality of life (EQ-5D-5L) that allows us to calculate Quality-Adjusted Life Years, and to subsequently calculate cost-effectiveness (Cost per Quality-Adjusted Life Years).

  93. Number of participants with CVD events (myocardial infarction, stroke), diabetes and premature deaths

    Time frame: 60 months

    Assessed using linkage to the Norwegian Patient Registry and the Norwegian Cause of Death Registry.

  94. Number of participants with intervention-related adverse events

    Time frame: 24 months

    Monitored consequently by intervention and outcome assessment personell

Sponsors and collaborators

Lead sponsor

University of Tromso

Other

Collaborators

  • KRAFT Sports Center
  • Molde University College
  • National Association for Heart and Lung Diseases, Tromso, Norway
  • Norwegian Trekking Association
  • Novo Nordisk A/S
  • The Research Council of Norway
  • Tromso Municipality
  • University Hospital of North Norway
  • University of Oslo

Registry information

Official study title

RE-inventing Strategies for Healthy Ageing; Recommendations and Tools (RESTART) - a Randomized Controlled Trial Testing a Complex Lifestyle Intervention in Older Adults at Increased Risk for Cardiometabolic Disease

Acronym: RESTART

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 8, 2023
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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