Lifestyle Intervention With Physical Activity and Diet

NCT06379802 | Active Not Recruiting

• 1 other identifier: 2023-00546-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this pilot randomized controlled trial LI-PAD is to identify whether a 6-month intervention approach to individually optimize lifestyle behavior, physical activity, and diet, is feasible and leads to larger improvements in body weight, cardiovascular disease risk factors, and health-related quality of life compared to simple written lifestyle advice, in individuals with overweight or obesity. The intervention group will be offered individual support for lifestyle behavioral change (precision health) and the control group will be offered written lifestyle advice, following national recommendations. In total, 60 population-based participants and 60 controls from the Gothenburg area, aged 45-65 years, will be recruited.

Conditions

Overweight

Keywords

Overweight; Healthy Lifestyle; Risk Reduction Behaviour; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (4)

• Change in body weight 1

  Reduction in body weight (kg) in percent will be identified by using Lidén weighing scale.

  From baseline to 6 months

• Change in body weight 2

  Reduction in body weight (kg) in percent will be identified by using Lidén weighing scale. Less weight at the 1-month follow-up than at baseline is a better outcome than vice versa.

  From baseline to 1 month (intervention group)

• Change in body weight 3

  Reduction in body weight (kg) in percent will be identified by using Lidén weighing scale. Less weight at the 3-month follow-up than at the 1-month follow-up is a better outcome than vice versa.

  From 1 month to 3 months (intervention group)

• Change in body weight 4

  Reduction in body weight (kg) in percent will be identified by using Lidén weighing scale. Less weight at the 6-month follow-up than at the 3-month follow-up is a better outcome than vice versa.

  From 3 months to 6 months (intervention group)

Secondary Outcomes (46)

• Length in cm

  From baseline to 6 months

• Weight in kilograms

  From baseline to 6 months

• Cardiovascular disease risk factor change - Body Mass Index (BMI)

  From baseline to 6 months

• Cardiovascular disease risk factor change - Waist-to-hip ratio 1

  From baseline to 6 months

• Cardiovascular disease risk factor change - Waist-to-hip ratio 2

  From baseline to 1 month (intervention group)

Study Arms (2)

Individualized physical activity and diet

EXPERIMENTAL

The intervention group will receive (offered) an optimal prescription of physical activity and diet based on medical (comorbidities, risk profile, medications, symptoms) and psycho-social (preferences for physical activities and diet, barriers-facilitators, social support, readiness to change, accelerometry and predicted VO2-max data (Ekblom Bak ergometer test), resting energy expenditure and knowledge and skills (lifestyle education school for achieving knowledge and skills in handling change in diet and physical activity in daily life) and support (health promotors, behavioral change app, food diary app, face-to-face, phone/online coaching, physical activity (aerobic training, strength training) in group and nudging.

Behavioral: Individualized physical activity and diet

Standard of care

NO INTERVENTION

The control group will receive (be offered) usual care defined as written lifestyle advices based on the general recommendations for diet (Nordic Nutrition Recommendations, 2012. Integrating nutrition and physical activity. Copenhagen: Nordic Council of Ministers, 2014) and PA (World Health Organization. World Health Organization guidelines on physical activity and sedentary behavior, 2020), including a healthy and varied diet, aiming at 300 mins/week of medium intensity aerobic PA and strength training two times per week.

Interventions

Individualized physical activity and diet BEHAVIORAL

Precision health

Individualized physical activity and diet

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 45-65 years
• A body mass index (BMI) of ≥28 and \<35

You may not qualify if:

• Known coronary artery disease (clinical symptoms/earlier event)
• Other contraindications such as inability to understand language or unable to perform lifestyle interventions

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Centre for lifestyle intervention

Gothenburg, Sweden

Location

Related Publications (23)

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  BACKGROUND

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  PMID: 36315564 BACKGROUND

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  BACKGROUND

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  BACKGROUND

• Kallings L, Eriksson M, Lundqvist S, Dohrn I. [Fysisk aktivitet på recept - FaR]. In: Dohrn I, Jansson E, Börjesson M, Hagströmer M, editors. FYSS2021, 4th ed. Stockholm: Läkartidningens Förlag; 2021. p. 142-51.

  BACKGROUND

• Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ, Jordan HS, Kendall KA, Lux LJ, Mentor-Marcel R, Morgan LC, Trisolini MG, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2014 Jun 24;129(25 Suppl 2):S102-38. doi: 10.1161/01.cir.0000437739.71477.ee. Epub 2013 Nov 12. No abstract available.

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MeSH Terms

Conditions

Overweight

Interventions

Diet

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Mats Börjesson, Professor

  Sahlgrenska University Hospital (and University of Gothenburg)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: April 23, 2024
• Study Start: February 12, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)