Dietary Recommendations for Reducing Free Sugar Intakes

Study Overview
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Brief Summary
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This randomised controlled trial aims to assess the impacts of the current recommendations by Public Health England for reducing free sugar intakes, on total energy intakes of free sugar in a sample of the UK population.

Detailed Description
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The primary objective of this randomised control trial is to assess the impacts of Public Health England's (PHE) current free sugar reducing advice, for reducing total energy intakes (TEI) of free sugar. A total of 240 participants (age 18-65years) consuming diets >5% total energy intake from dietary free sugars will be recruited from across the Dorset region. Participants to be randomly assigned into the following recommendation interventions groups: 1) Reduce free sugar intake to <5% TEI (nutrient-based recommendations); 2) Reduce free sugar intake to <5% TEI, via reducing intake of specific foods identified as high in free sugars (nutrient- + food-based recommendations); 3) Reduce free sugar intake to <5% TEI, via reducing intake of specific foods identified as high in free sugars and replace/swap with low sugar versions (nutrient- + food-based recommendations with swaps); and 4) Control Group. The primary outcome will be changes in free sugar consumption from baseline to endpoint at week 12. Secondary outcomes include change in: BMI; dietary profiles; sweetness preference; sweetness liking; food choices; low calorie sweetener intakes and adherence levels.

Official Title
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Dietary Recommendations for Reducing Free Sugar Intakes

Conditions
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Dietary Recommendations

Intervention / Treatment
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* Behavioral: Dietary recommendations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18-65 years; able to provide consent and complete all study materials; consuming >5% of TEI from free sugars; and residing in the South of England. Exclusion criteria: individuals who are pregnant or breastfeeding; underweight (BMI <18.5); have pre-existing medical conditions affecting swallow ability, taste and smell perception; currently or within 3 months of starting the study are following a specific dietary programme (e.g.: Slimming World); current smokers or have smoked within 3 months of the study start date; have pre-existing clinical conditions such as diabetes mellitus, eating disorders, Crohn's disease and other illness's leading to participants receiving external nutritional advice and dietary restrictions.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutrient-based recommendations<br>Participants in this group will be given nutrient-based recommendations to reduce free sugar intakes. | Behavioral: Dietary recommendations<br>* Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations<br>|
| Experimental: Nutrient- and food-based recommendations<br>Participants in this group will be given nutrient- and food-based recommendations to reduce free sugar intakes. | Behavioral: Dietary recommendations<br>* Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations<br>|
| Experimental: Nutrient- and food-based recommendations with food swaps<br>Participants in this group will be given nutrient- and food-based recommendations and advice on food swaps to reduce free sugar intakes. | Behavioral: Dietary recommendations<br>* Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations<br>|
| Placebo Comparator: Control<br>Participants in this group will not be given any recommendations to reduce free sugar intakes. | Behavioral: Dietary recommendations<br>* Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free sugar intakes | Percentage energy intake from free sugars, assessed using diet diaries | 12 weeks from baseline | 
| Adherence | Adherence to the recommendations provided, assessed using diet diaries and self-reported adherence | 12 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary intakes | Nutrient composition of dietary intakes, assessed using diet diaries | 12 weeks from baseline | 
| BMI | Body Mass Index, assessed using researcher measurements or researcher-observed self-measurements | 12 weeks from baseline | 
| Sweet food preferences | Preferences for various sweet foods/fluids, assessed using a taste test, where participants sample several sweet and non-sweet foods and rate them for pleasantness on a 100mm Visual Analogue Scale. Higher scores signify stronger preferences | 12 weeks from baseline | 
| Sweet food choices | Selection of sweet foods/fluids at a given meal, assessed where participants can consume freely from a meal composed of sweet and non-sweet foods, and proportion of sweet foods consumed is measured in terms of weight consumed | 12 weeks from baseline | 
| Sweet food attitudes | Attitudes towards sugar, sweeteners, and sweet-tasting foods, assessed using a questionnaire, soon to be published. Higher scores denote stronger attitudes. | 12 weeks from baseline | 
| Adverse events | Adverse events, assessed by self-report | Baseline to 12 weeks | 
| Eating-based attitudes | Attitudes towards eating, assessed using the Three Factor Eating Questionnaire (Karlsson J, et al. IJO 2000; 24: 1715-1725) | Baseline to 12 weeks | 
| Eating-based motivations | Motivations towards eating, assessed using the Food Choice Questionnaire (Steptoe et al., Appetite 1995, 25(3): 267-84). Higher scores denote stronger motivations | Baseline to 12 weeks | 
| Quality of Life (subjective wellbeing) | Quality of Life, measured using the SF-36 questionnaire (Ware et al, 1996), where Quality of Life is assessed out of 100, where a higher score demonstrates better quality of life | Baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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free sugars, dietary intake, dietary recommendations