Dietary Recommendations for Reducing Free Sugar Intakes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Free Sugar Intakes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigator, all researchers and analysts will be blinded to treatment. Participants can not masked.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Nutrient-based recommendations
Participants in this group will be given nutrient-based recommendations to reduce free sugar intakes.
干预措施: Dietary recommendations (Behavioral)
Nutrient- and food-based recommendations
Participants in this group will be given nutrient- and food-based recommendations to reduce free sugar intakes.
干预措施: Dietary recommendations (Behavioral)
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.
干预措施: Dietary recommendations (Behavioral)
Control
Participants in this group will not be given any recommendations to reduce free sugar intakes.
干预措施: Dietary recommendations (Behavioral)
结局指标
主要结局
Free Sugar Intakes
时间窗: 12 weeks from baseline
Percentage energy intake from free sugars, assessed using diet diaries
Number of Participants Who Adhered to the Recommendations Provided
时间窗: 12 weeks from baseline
Adherence to the recommendations provided, assessed using diet diaries and self-reported adherence
次要结局
- Number of Participants Reporting Adverse Events(Baseline to 12 weeks)
- Eating-based Motivations(Baseline to 12 weeks)
- Quality of Life (Subjective Wellbeing)(Baseline to 12 weeks)
- Sweet Food Preferences(12 weeks from baseline)
- Sweet Food Attitudes(12 weeks from baseline)
- Dietary Intakes(12 weeks from baseline)
- BMI(12 weeks from baseline)
- Sweet Food Choices(12 weeks from baseline)
- Eating-based Attitudes(Baseline to 12 weeks)