A Study to Investigate the Short and Long Term Effects of Two 12-week Healthy Eating Interventions on Body Weight, Body Composition, Appetite Control, Biomarkers of Health and Subjective Wellbeing in Overweight Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- body weight change (kg) during the 12 week intervention
研究概览
简要总结
The purpose of this parallel design study is to assess the relative effects of two 12-week healthy eating dietary interventions: general healthy eating (Diet A) and general healthy eating combined with advice to increase fibre intake (Diet B) to at least 25g/day (with a large proportion of the fibre intake derived from cereal or wheat bran), in overweight low-fibre consuming premenopausal female adults on body weight change (kg). It is hypothesized that adding fibre to a healthy eating diet (Diet B) would lead to greater weight loss and/or weight loss maintenance than following a healthy eating diet alone (Diet A).
详细描述
In this randomised, single blind, parallel design study participants were randomly assigned to one of two 12-week healthy eating dietary interventions: Diet A: general healthy eating OR Diet B: general healthy eating combined with advice to increase fibre intake to at least 25g/day (with a large proportion of the fibre intake derived from cereal or wheat bran.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-48 years of age (premenopausal)
- •Self reported good health
- •Body Mass Index (BMI) within overweight/obese range (26-35kg/m2)
- •Willingness to consume study foods and prepared to eat breakfast cereals as part of the intervention
- •Non-smokers or given up more than 6 months ago
- •Exercising no more than 4 times per week at a medium intensity
- •Weight stable in the last 3 months (fluctuation of no more than 3kg)
- •Current fibre intake (≤ 15g/day) according to DINE and verified by 7 day food diary (fibre points)
- •Ability to adequately understand verbal and written information in English
排除标准
- •Menopausal or showing menopausal symptoms (e.g. frequent/recurrent hot flushes) at screening or taking any supplements for menopausal symptoms
- •Type 2 Diabetes; Cardiac pacemaker fitted
- •Taking medication and/or supplements known to affect appetite/body weight in the last 6 months (e.g. asthma, steroids, anti-depressants)
- •BMI outside range of 26-35 kg/m2
- •Food allergies or aversions to foods likely to be consumed within the study (e.g. wheat bran, nuts)
- •Non-smokers or given up more than 6 months ago
- •Exercising more than 4 times per week at a medium intensity
- •Shift work (night shifts)
- •Pregnant or planning a pregnancy within the next year; having been pregnant or lactating within the previous 6 months
- •No history of, or current eating disorders as determined using the Eating Attitudes Test (EAT-26;Gardner et al., 1982; a score higher than 20)
- •Current fibre intake (>15g/day according to DINE)
- •Insufficient English language skills to complete all study questionnaires
结局指标
主要结局
body weight change (kg) during the 12 week intervention
时间窗: at screening and every 4 weeks at each subsequent visit, the last week of the intervention (week 12), at one month and one year after the intervention has finished
Body weight will be measured three times using ADP (BodPod, Concord, CA, USA); once during the inclusion phase (week -1), at the end of the intervention (week 12) and at follow up (one year later). Body weight will also be measured six times using bioimpedance (Tanita, Illinois, USA); once during the inclusion phase (week -1) and then again during weeks 4, 8, 12 of the intervention phase and at follow up (one month later and one year later)
次要结局
- Food Intake(7 day food diary the week before starting the intervention; 3 day food diaries at baseline (first week of the intervention), then baseline +4 weeks, baseline +8 weeks, baseline +12 weeks, baseline +12 months)
- Glycaemic regulation(at baseline (first week of the intervention over a period of 3 days) and at baseline +12 weeks (last week of the intervention over a period of 3 days))
- Biochemical measures(at baseline (first week of the intervention) and then at baseline +12 weeks (last week of the intervention))
- Subjective symptoms, wellbeing and Mood(Wellbeing Diary Booklets (WDBs) will be completed each day from screening till the last week of the intervention (week 12))
- Sleep and body shape perception(at baseline (first week of the intervention), baseline +4 weeks, baseline +8 weeks, baseline +12 weeks, baseline +16 weeks and then at baseline +12 months)
- Eating behaviour(at baseline (first week of the intervention), baseline +4 weeks, baseline +8 weeks, baseline +12 weeks, baseline +16 weeks and then at baseline +12 months)
- Diet Satisfaction(at baseline +12 months)
- Depression Anxiety and Stress(at baseline +12 months)
- Life events(at baseline +12 months)
- Dietary fibre intake(at recruitment visit, at baseline +12 weeks, at baseline +16 weeks and at baseline +12 months)
- body composition(at baseline (first week of the intervention), baseline +4 weeks, baseline +8 weeks, baseline +12 weeks, baseline +16 weeks and then at baseline +12 months)
- Waist circumference(at baseline (first week of the intervention), baseline +4 weeks, baseline +8 weeks, baseline +12 weeks, baseline +16 weeks and then at baseline +12 months)
- Appetite ratings(Five times over a period of 2 hours during a test meal challenge day once at the beiginning of the intervention (baseline) and once at the end of the intervention (baseline +12 months))
- Food preferences(Before and after consumption of a fixed energy test meal at baseline (first week of the intervention) and again before and after the second test meal at the last week of the intervention (baseline + 12 months))
研究者
Prof Louise Dye
Professor
University of Leeds