Lifestyle Change: The Impact on Body Composition, Resting Metabolic Rate, Food Intake and Health-related Quality of Life

NCT07103005 | Active Not Recruiting DMC

• 2 other identifiers: 761798Reference number: 193383
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

In Norway, a significant proportion of the adult population is currently classified as overweight (\~50%) or obese (\~23%). Over the past four decades, there has been a significant rise in the prevalence of overweight and obesity in both children and adults. Obesity is associated with a higher risk of chronic diseases such as cardiovascular diseases, type 2 diabetes, respiratory disease, osteoarthritis and specific cancers. Consequently, leading to increased morbidity and reduction in life expectancy. A healthy lifestyle including meeting recommendations for diet and physical activity is considered beneficial the prevention of chronic diseases, and for quality of life. There is limited evidence on weight reduction programs implemented outside specialized healthcare services, however intensive lifestyle modifications have demonstrated promising effects on sustainable weight loss. The Kickstart Program is a lifestyle program addressing weight reduction, changes in body composition and improved health-related quality of life (HRQoL) by integrating personalized dietary guidance and physical activity (PA) over a three, four or six-month period for registered participants, and can be considered an organized follow-up intervention. The participants receive close monitoring and support from clinical dietitians, physiotherapists and personal trainers. Unlike patients in specialized healthcare, Kickstart participants sign up and pay for it themselves, without any support from referrals or financial aid. This financial commitment is thought to make participants more motivated and facilitate compliance with the program. Recognizing the potential of programs like Kickstart to reduce healthcare costs by preventing lifestyle diseases, especially outside of specialized healthcare, shows why it is important to study how well they work. The study's findings can be leveraged to assess the influence of lifestyle programs and enhance the support available to adults with obesity. The study will tighten the knowledge gap concerning how an intervention of intensive dietary changes and PA specifically effects weight loss, FFM and HRQoL within a three-month timeframe. The overall aim of the study is to investigate the effect of a combined diet and PA intervention for people with a BMI\>25 kg/m² on body weight, body composition, RMR and HRQoL.

Conditions

Obesity and Overweight

Keywords

Body composition; healthy diet

Outcome Measures

Primary Outcomes (5)

• Bioelectircal impedance (BIA)

  Measurements of body composition i.e muscle mass was assessed by BIA

  Base line to three months, and one year follow up

• Dual-Energy X-Ray Absorptiometry (DEXA).

  Measurements of body composition i.e muscle mass was also assessed by DEXA

  Base line to three months, and one year follow up

• Resting energy expenditure (REE)

  REE was measured with indirect calorimetry

  Base line to three months, and one year follow up

• Questionnaire RAND 36-Item Short Form Health Survey (RAND-36)

  health related quality of life (HQoL) was assesed with RAND-36. RAND-36 has 36 questions with 8 dimentions. The scales are from 1-3 or 1-5. Low value estimates low scores.

  Base line to three months, and one year follow up

• Assessment of diet with Digikost questionnaire

  Diet change was measured with a validated digital food frequency questionnaire (FFQ): Digikost. The DIGIKOST-FFQ assesses data on single food items as well as food groups according to the Norwegian FBDG and the data is presented in grams per day. DIGIKOST-FFQ also presents variables of different food groups according to the recommendations (Norwegian food-based dietary guidelines)

  Base line to three months, and one year follow up

Study Arms (1)

A Commercial intensiv intervention with physical activity and diet. A single-group pre-post design

EXPERIMENTAL

All participants recieved the lifestyle intervention. Camparisons were made before and after the intervention. Body composition, Health realted quality of life and diet was registered before and after the intervention.

Procedure: Intensive behavioral change with physical activity and diet. A single-group pre-post design

Interventions

Intensive behavioral change with physical activity and diet. A single-group pre-post design PROCEDURE

The group of 43 participants recieved a lifestyle intervention, and was measurred before and after the intervention. The intervention was intensive physical activity with focus om muscle strength and dietary advice from dietition, with focus on more fruits, vegetables, proteins and fiber. Body composition was measurred using Bioelectrical impedance, DEXA and WRIC. Health related quality of life was measured using the questionnaire RAND-36, and diet was registered with the questionnaire DIGIKOST.

Also known as: Diet, Physical activity, social support

A Commercial intensiv intervention with physical activity and diet. A single-group pre-post design

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \> 25 kg/m2

You may not qualify if:

• BMI\< 25 kg/m2

Sponsors & Collaborators

• VID Specialized University: lead

Study Sites (1)

VID Specialized University

Oslo, 0370, Norway

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Exercise; Diet

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Leader

Model Details: This study has a single group pre-post design. The intervention is an intensiv lifestyle intervention with physical activity focusing on muscle strength, and diet change focusing on more fruits, vegetables, proteins and fiber. Measurements were done before and after the intervention. Methods that were used were Bioelectrical impedance to measure body composition, questionires as RAND-36 to meassure HQoL, and DIGIKOST to measure diet. We also registered muscle- and fat mass with Dual-energy Ray Absorptiometry (DEXA) and whole-room indirect calorimet (WRIC).

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: August 5, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2028
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)