Clinical trial NCT01539369: The Leeds Women's Wellbeing (LWW) Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Keywords: dietary intervention
dietary fibre
weight loss
weight maintenance
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2012-02-27
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Female
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: body weight change (kg) during the 12 week intervention
timeFrame: 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
Secondary outcomes:
measure: Food Intake
timeFrame: 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
measure: Glycaemic regulation
timeFrame: 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)
measure: Biochemical measures
timeFrame: at baseline (first week of the intervention) and then at baseline +12 weeks (last week of the intervention)
measure: Subjective symptoms, wellbeing and Mood
timeFrame: Wellbeing Diary Booklets (WDBs) will be completed each day from screening till the last week of the intervention (week 12)
measure: Sleep and body shape perception
timeFrame: 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
measure: Eating behaviour
timeFrame: 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
measure: Diet Satisfaction
timeFrame: at baseline +12 months
measure: Depression Anxiety and Stress
timeFrame: at baseline +12 months
measure: Life events
timeFrame: at baseline +12 months
measure: Dietary fibre intake
timeFrame: at recruitment visit, at baseline +12 weeks, at baseline +16 weeks and at baseline +12 months
measure: body composition
timeFrame: 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
measure: Waist circumference
timeFrame: 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
measure: Appetite ratings
timeFrame: 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)
measure: Food preferences
timeFrame: 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)
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Institute of Psychological Sciences
Study officials:
affiliation: University of Leeds
name: Louise Dye, Professor
role: PRINCIPAL_INVESTIGATOR
References: