RE-inventing Strategies for Healthy Ageing; Recommendations and Tools

Summary

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.

Conditions

• Lifestyle, Healthy
• Muscle Weakness
• Abdominal Obesity
• Cardiometabolic Syndrome
• Self Efficacy
• Diet, Healthy

Interventions

BEHAVIORAL

Complex lifestyle intervention

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.

BEHAVIORAL

Physical activity monitoring and recommendations

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.

Sponsors & Collaborators

• The Research Council of Norway

  collaborator OTHER

• Novo Nordisk A/S

  collaborator INDUSTRY

• Tromso Municipality

  collaborator UNKNOWN

• University Hospital of North Norway

  collaborator OTHER

• University of Oslo

  collaborator OTHER

• Molde University College

  collaborator OTHER

• National Association for Heart and Lung Diseases, Tromso, Norway

  collaborator UNKNOWN

• Norwegian Trekking Association

  collaborator UNKNOWN

• KRAFT Sports Center

  collaborator UNKNOWN

• University of Tromso

  lead OTHER

Principal Investigators

• Sameline Grimsgaard, PhD · UiT The Arctic University of Norway

• Jonas Johansson, PhD · UiT The Arctic University of Norway

• Trygve Deraas, PhD · UiT The Arctic University of Norway

• Camilla Flåten, MSc · UiT The Arctic University of Norway

• André Henriksen, PhD · UiT The Arctic University of Norway

• Laila Hopstock, PhD · UiT The Arctic University of Norway

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-15

Primary Completion

2026-06-30

Completion

2027-06-30

Countries

• Norway

Study Locations