An individualised Lifestyle Intervention with Physical Activity and Diet in individuals with overweight and obesity (LI-PAD)—study protocol of a 6-month randomised controlled study {1a}

TL;DR

This study tests if personalized lifestyle advice on diet and exercise leads to better weight loss and health outcomes than standard advice in overweight and obese individuals.

Contribution

The study introduces individualized lifestyle support in a clinical setting to address behavior change in obesity management.

Findings

The intervention will assess improvements in weight loss and cardiometabolic risk factors.

Health-related quality of life will be evaluated as a secondary outcome.

The study will use multilevel mixed modeling to analyze repeated measures data.

Abstract

Overweight and obesity increase the risk of cardiometabolic disease, and sustainable lifestyle change remains difficult to achieve. The primary objective of this randomised controlled trial will be to identify whether a 6-month individualised intervention in physical activity and diet, offering flexible support strategies, is effective and feasible and leads to larger improvements in weight loss, other cardiometabolic disease risk factors, and health-related quality of life compared with standard written lifestyle advice.

Eligible participants will be 45–65 years old men and women residing in the Gothenburg area, with a body mass index of ≥28 and <35. We intend to recruit 120 females and males, who are randomly allocated in a 1:1 ratio to either the intervention or control group. The intervention group will undergo a 6-month intervention of individually tailored support and guidance on lifestyle behaviours encompassing physical activity and dietary modifications. The control group will receive standard lifestyle advice based on general physical activity and dietary recommendations, respectively. The primary outcome measure will be weight loss from baseline to the 6-month follow-up. The study will be conducted at the Centre for Lifestyle Intervention, Sahlgrenska University Hospital, Gothenburg, Sweden. Data analysis will employ multilevel mixed modelling for repeated measures, alongside linear and logistic analyses, adhering to an intention-to-treat approach.

By addressing critical health metrics, such as weight, blood pressure, and physical activity, using individualised advice based on objective data, this intervention will move beyond a one-size-fits-all strategy when tackling complex behaviour change challenges in overweight and obesity management and reducing cardiometabolic disease risk. Introducing health promoters in a clinical setting will be a novel approach.

The study is prospectively registered on researchweb.org on 2 January 2024 (project number 281907) and subsequently at ClinicalTrials.gov, NCT06379802 on 9 February 2024 (approval number/ID: 2023-00546-01).

The online version contains supplementary material available at 10.1186/s13063-026-09606-6.

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