Dietary Recommendations
Conditions
Keywords
free sugars, dietary intake, dietary recommendations
Brief summary
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
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.
Interventions
BEHAVIORALDietary recommendations
Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
Sponsors
Bournemouth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The investigator, all researchers and analysts will be blinded to treatment. Participants can not masked.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Free Sugar Intakes | 12 weeks from baseline | Percentage energy intake from free sugars, assessed using diet diaries |
| Number of Participants Who Adhered to the Recommendations Provided | 12 weeks from baseline | Adherence to the recommendations provided, assessed using diet diaries and self-reported adherence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sweet Food Preferences | 12 weeks from baseline | 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 |
| Sweet Food Choices | 12 weeks from baseline | 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 |
| Sweet Food Attitudes | 12 weeks from baseline | Attitudes towards sugar, sweeteners, and sweet-tasting foods, assessed using a questionnaire, soon to be published. Higher scores denote stronger attitudes. |
| Dietary Intakes | 12 weeks from baseline | Energy intake, assessed using diet diaries |
| Eating-based Attitudes | Baseline to 12 weeks | Attitudes towards eating, assessed using the Three Factor Eating Questionnaire (Karlsson J, et al. IJO 2000; 24: 1715-1725) |
| Eating-based Motivations | Baseline to 12 weeks | Motivations towards eating, assessed using the Food Choice Questionnaire (Steptoe et al., Appetite 1995, 25(3): 267-84). Higher scores denote stronger motivations |
| Quality of Life (Subjective Wellbeing) | Baseline to 12 weeks | 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 |
| Number of Participants Reporting Adverse Events | Baseline to 12 weeks | Adverse events, assessed by self-report |
| BMI | 12 weeks from baseline | Body Mass Index, assessed using researcher measurements or researcher-observed self-measurements |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 61 |
| 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 | 60 |
| 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 | 63 |
| 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 | 58 |
| Total | 242 |
Baseline characteristics
| Characteristic | Nutrient-based Recommendations | Nutrient- and Food-based Recommendations | Nutrient- and Food-based Recommendations With Food Swaps | Control | Total |
|---|---|---|---|---|---|
| Age, Continuous | 42.4 years STANDARD_DEVIATION 14 | 38.3 years STANDARD_DEVIATION 12.2 | 42.5 years STANDARD_DEVIATION 13.4 | 41.7 years STANDARD_DEVIATION 12.6 | 41.3 years STANDARD_DEVIATION 13.1 |
| Free sugar intakes | 10.1 percentage of total energy intake STANDARD_DEVIATION 5.2 | 10.7 percentage of total energy intake STANDARD_DEVIATION 4.8 | 10.2 percentage of total energy intake STANDARD_DEVIATION 4.4 | 10.4 percentage of total energy intake STANDARD_DEVIATION 5.1 | 10.3 percentage of total energy intake STANDARD_DEVIATION 4.8 |
| Race/Ethnicity, Customized Other background | 8 participants | 10 participants | 5 participants | 7 participants | 30 participants |
| Race/Ethnicity, Customized White | 53 participants | 50 participants | 58 participants | 51 participants | 212 participants |
| Region of Enrollment United Kingdom | 61 participants | 60 participants | 63 participants | 58 participants | 242 participants |
| Sex: Female, Male Female | 54 Participants | 52 Participants | 55 Participants | 53 Participants | 214 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 8 Participants | 5 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 60 | 0 / 63 | 0 / 58 |
| other Total, other adverse events | 0 / 61 | 0 / 60 | 0 / 63 | 0 / 58 |
| serious Total, serious adverse events | 1 / 61 | 1 / 60 | 2 / 63 | 1 / 58 |
Outcome results
Primary
Free Sugar Intakes
Percentage energy intake from free sugars, assessed using diet diaries
Time frame: 12 weeks from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nutrient-based Recommendations | Free Sugar Intakes | 7.7 percentage of total energy intake | Standard Error 0.7 |
| Nutrient- and Food-based Recommendations | Free Sugar Intakes | 7.4 percentage of total energy intake | Standard Error 0.7 |
| Nutrient- and Food-based Recommendations With Food Swaps | Free Sugar Intakes | 7.1 percentage of total energy intake | Standard Error 0.6 |
| Control | Free Sugar Intakes | 9.2 percentage of total energy intake | Standard Error 0.7 |
Primary
Number of Participants Who Adhered to the Recommendations Provided
Adherence to the recommendations provided, assessed using diet diaries and self-reported adherence
Time frame: 12 weeks from baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nutrient-based Recommendations | Number of Participants Who Adhered to the Recommendations Provided | 38 participants |
| Nutrient- and Food-based Recommendations | Number of Participants Who Adhered to the Recommendations Provided | 39 participants |
| Nutrient- and Food-based Recommendations With Food Swaps | Number of Participants Who Adhered to the Recommendations Provided | 39 participants |
| Control | Number of Participants Who Adhered to the Recommendations Provided | 25 participants |
Secondary
BMI
Body Mass Index, assessed using researcher measurements or researcher-observed self-measurements
Time frame: 12 weeks from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nutrient-based Recommendations | BMI | 27.2 kg/m2 | Standard Error 0.7 |
| Nutrient- and Food-based Recommendations | BMI | 28.1 kg/m2 | Standard Error 0.7 |
| Nutrient- and Food-based Recommendations With Food Swaps | BMI | 27.1 kg/m2 | Standard Error 0.7 |
| Control | BMI | 27.4 kg/m2 | Standard Error 0.8 |
Secondary
Dietary Intakes
Energy intake, assessed using diet diaries
Time frame: 12 weeks from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nutrient-based Recommendations | Dietary Intakes | 1512 kcal/day | Standard Error 60 |
| Nutrient- and Food-based Recommendations | Dietary Intakes | 1466 kcal/day | Standard Error 70 |
| Nutrient- and Food-based Recommendations With Food Swaps | Dietary Intakes | 1495 kcal/day | Standard Error 56 |
| Control | Dietary Intakes | 1516 kcal/day | Standard Error 56 |
Secondary
Eating-based Attitudes
Attitudes towards eating, assessed using the Three Factor Eating Questionnaire (Karlsson J, et al. IJO 2000; 24: 1715-1725)
Time frame: Baseline to 12 weeks
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
Time frame: Baseline to 12 weeks
Secondary
Number of Participants Reporting Adverse Events
Adverse events, assessed by self-report
Time frame: Baseline to 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nutrient-based Recommendations | Number of Participants Reporting Adverse Events | 1 participants |
| Nutrient- and Food-based Recommendations | Number of Participants Reporting Adverse Events | 1 participants |
| Nutrient- and Food-based Recommendations With Food Swaps | Number of Participants Reporting Adverse Events | 2 participants |
| Control | Number of Participants Reporting Adverse Events | 1 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
Time frame: Baseline to 12 weeks
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.
Time frame: 12 weeks from baseline
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
Time frame: 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
Time frame: 12 weeks from baseline