NCT05627570

A Study Comparing the Health Effects of Two Diets Following UK Dietary Guidance in People Living With Overweight or Obesity

Investigating the Effects of Diets With Different Types of Food Processing Following UK dietAry Guidance on healTh outcomEs: an 8-week Community-based Crossover Randomised Controlled Trial in People With Overweight or Obesity, Followed by a 6-month Behavioural Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

There are two parts to this study: 1. The investigators will study if the benefit from eating a healthy, balanced diet depends on the types of food processing in the diet. The investigators will do this by providing participants with two diets that follow the Eatwell Guide (referred to in this study as Diet A and Diet B to avoid unblinding), but containing foods with different types of food processing, for 8 weeks each. The investigators will collect data on blood pressure, body composition, physical activity and fitness, questions regarding quality of life, mental health and wellbeing, and blood samples at the start of each diet and at 4 and 8 weeks into each diet. 2. The investigators will then study whether participants are able to switch from their usual unhealthy diet to a healthy, balanced diet, and the benefits of doing so. The investigators will do this by providing participants with 6 months of personal support. The investigators will also look at what helps participants to maintain a healthy diet, and what makes it difficult. The investigators will also support participants to be more physically active.

Detailed description

Eating a healthy, balanced diet is important for health. A healthy, balanced diet involves eating a variety of foods in the right proportions. In the UK, the Eatwell Guide gives recommendations on what people should eat more of, and what people should eat less of. Unhealthy diets contain lots of foods high in saturated fat, added sugar and salt, which increases the risk of developing obesity, cardiovascular disease and type 2 diabetes. Advice for a healthy, balanced diet includes consuming five portions of fruit and vegetables per day and eating more high fibre foods. Following the healthy, balanced diet advice given in the Eatwell Guide can reduce the risk of poor health. However, there are other parts of the diet that are not covered in the Eatwell Guide that may also be important for health. For example, research suggests that different types of food processing might influence health, but these types of food processing are not included within the recommendations. It is unknown if the benefits of following the healthy diet advice in the Eatwell Guide depend on the types of food processing in the diet. It is important to find out if these types of food processing matter, in order to give people the best advice possible. It also means that the government and other health organisations may need to change the regulations around the food that people eat. To answer this, the investigators will compare the effects of two healthy, balanced diets following the advice in the UK Eatwell Guide, but each based on a different type of food processing (referred to in this study as Diet A and Diet B to avoid unblinding). Participants will receive the first diet for 8 weeks, return to their normal diet for 4 weeks, and then receive the second diet for a further 8 weeks. Participants will have 6 months of support to help improve their diet and be more physically active. Participants will work with a behavioural scientist to create a personal plan to eat a healthier diet and be more physically active, using behaviour change techniques based on capability, opportunity, motivation - behaviour (COM-B) theory of behaviour change. This support will last for 6 months, with ongoing monthly telephone/video calls with the research team. The results from this study will be used to help inform UK dietary guidance and food policy. There are two parts to this study: 1. The investigators will study if the benefit from eating a healthy, balanced diet depends on the types of food processing in the diet. The investigators will do this by providing participants with two diets (Diet A and Diet B) that follow the Eatwell Guide, but containing foods with different types of processing, for 8 weeks each. 2. The investigators will then study whether participants are able to switch from their usual unhealthy diet to a healthy, balanced diet, and the benefits of doing so. The investigators will do this by providing participants with 6 months of personal support. The investigators will also look at what helps participants to maintain a healthy diet, and what makes it difficult. The investigators will also support participants to be more physically active.

Conditions

• Obesity
• Cardiometabolic Syndrome
• Overweight

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Healthy, balanced Diet A	Healthy, balanced diet following Eatwell Guide recommendations
DIETARY_SUPPLEMENT	Healthy, balanced Diet B	Healthy, balanced diet following Eatwell Guide recommendations
BEHAVIORAL	Behavioural support intervention	Participants will work with a behavioural scientist to create a personal plan to eat a healthier diet and be more physically active. This support will last for 6 months, with ongoing monthly telephone/video calls with the research team.

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-10-14
• Completion: 2025-06-04
• First posted: 2022-11-25
• Last updated: 2025-06-24

Locations

1 site across 1 country: United Kingdom