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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrient-based recommendations | Experimental | Participants in this group will be given nutrient-based recommendations to reduce free sugar intakes. |
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| Nutrient- and food-based recommendations | Experimental | Participants in this group will be given nutrient- and food-based recommendations to reduce free sugar intakes. |
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| Nutrient- and food-based recommendations with food swaps | Experimental | Participants in this group will be given nutrient- and food-based recommendations and advice on food swaps to reduce free sugar intakes. |
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| Control | Placebo Comparator | Participants in this group will not be given any recommendations to reduce free sugar intakes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary recommendations | Behavioral | Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations |
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| Measure | Description | Time Frame |
|---|---|---|
| Free Sugar Intakes | Percentage energy intake from free sugars, assessed using diet diaries | 12 weeks from baseline |
| Number of Participants Who Adhered to the Recommendations Provided | Adherence to the recommendations provided, assessed using diet diaries and self-reported adherence | 12 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary Intakes | Energy intake, assessed using diet diaries | 12 weeks from baseline |
| BMI | Body Mass Index, assessed using researcher measurements or researcher-observed self-measurements |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Appleton | Bournemouth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bournemouth University | Bournemouth | US and Canada Only | BH12 5BB | United Kingdom |
Anonymised study data will be available on completion of the trial from the PI
On study completion
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| ID | Title | Description |
|---|---|---|
| FG000 | Nutrient-based Recommendations | Participants in this group will be given nutrient-based recommendations to reduce free sugar intakes. Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations |
| FG001 | Nutrient- and Food-based Recommendations | Participants in this group will be given nutrient- and food-based recommendations to reduce free sugar intakes. Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations |
| FG002 | Nutrient- and Food-based Recommendations With Food Swaps | Participants in this group will be given nutrient- and food-based recommendations and advice on food swaps to reduce free sugar intakes. Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations |
| FG003 | Control | Participants in this group will not be given any recommendations to reduce free sugar intakes. Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nutrient-based Recommendations | Participants in this group will be given nutrient-based recommendations to reduce free sugar intakes. Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations |
| BG001 | Nutrient- and Food-based Recommendations |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Free Sugar Intakes | Percentage energy intake from free sugars, assessed using diet diaries | Posted | Mean | Standard Error | percentage of total energy intake | 12 weeks from baseline |
|
12 weeks
Self-report
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nutrient-based Recommendations | Participants in this group will be given nutrient-based recommendations to reduce free sugar intakes. Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse event | General disorders | Systematic Assessment | Details not requested |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Katherine Appleton | Bournemouth University | 01202965985 | k.appleton@bournemouth.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | May 31, 2025 | Jun 6, 2025 | Prot_ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 28, 2023 | Jul 9, 2023 | SAP_000.pdf |
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The investigator, all researchers and analysts will be blinded to treatment. Participants can not masked.
| 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 |
| Number of Participants Reporting 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 |
Participants in this group will be given nutrient- and food-based recommendations to reduce free sugar intakes. Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations |
| BG002 | Nutrient- and Food-based Recommendations With Food Swaps | Participants in this group will be given nutrient- and food-based recommendations and advice on food swaps to reduce free sugar intakes. Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations |
| BG003 | Control | Participants in this group will not be given any recommendations to reduce free sugar intakes. Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Free sugar intakes | Mean | Standard Deviation | percentage of total energy intake |
|
| OG002 | Nutrient- and Food-based Recommendations With Food Swaps | Participants in this group will be given nutrient- and food-based recommendations and advice on food swaps to reduce free sugar intakes. Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations |
| OG003 | Control | Participants in this group will not be given any recommendations to reduce free sugar intakes. Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations |
|
|
| Primary | Number of Participants Who Adhered to the Recommendations Provided | Adherence to the recommendations provided, assessed using diet diaries and self-reported adherence | Posted | Number | participants | 12 weeks from baseline |
|
|
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| Secondary | Dietary Intakes | Energy intake, assessed using diet diaries | Posted | Mean | Standard Error | kcal/day | 12 weeks from baseline |
|
|
|
| Secondary | BMI | Body Mass Index, assessed using researcher measurements or researcher-observed self-measurements | Posted | Mean | Standard Error | kg/m2 | 12 weeks from baseline |
|
|
|
| Secondary | 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 | Not Posted | 12 weeks from baseline | Participants |
| Secondary | 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 | Not Posted | 12 weeks from baseline | Participants |
| Secondary | Sweet Food Attitudes | Attitudes towards sugar, sweeteners, and sweet-tasting foods, assessed using a questionnaire, soon to be published. Higher scores denote stronger attitudes. | Not Posted | 12 weeks from baseline | Participants |
| Secondary | Number of Participants Reporting Adverse Events | Adverse events, assessed by self-report | Posted | Number | participants | Baseline to 12 weeks |
|
|
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| Secondary | Eating-based Attitudes | Attitudes towards eating, assessed using the Three Factor Eating Questionnaire (Karlsson J, et al. IJO 2000; 24: 1715-1725) | Not Posted | Baseline to 12 weeks | Participants |
| Secondary | 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 | Not Posted | Baseline to 12 weeks | Participants |
| Secondary | 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 | Not Posted | Baseline to 12 weeks | Participants |
| 0 |
| 61 |
| 1 |
| 61 |
| 0 |
| 61 |
| EG001 | Nutrient- and Food-based Recommendations | Participants in this group will be given nutrient- and food-based recommendations to reduce free sugar intakes. Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations | 0 | 60 | 1 | 60 | 0 | 60 |
| EG002 | Nutrient- and Food-based Recommendations With Food Swaps | Participants in this group will be given nutrient- and food-based recommendations and advice on food swaps to reduce free sugar intakes. Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations | 0 | 63 | 2 | 63 | 0 | 63 |
| EG003 | Control | Participants in this group will not be given any recommendations to reduce free sugar intakes. Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations | 0 | 58 | 1 | 58 | 0 | 58 |
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