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The Leeds Women's Wellbeing (LWW) Study (LWW)

Primary Purpose

Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Healthy eating diet (Diet A) or healthy eating diet combined with advice to increase fibre intake (Diet B) to at least 25g/day
Sponsored by
University of Leeds
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Weight Loss focused on measuring dietary intervention, dietary fibre, weight loss, weight maintenance

Eligibility Criteria

18 Years - 48 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Institute of Psychological Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High fibre diet

Healthy eating diet

Arm Description

Outcomes

Primary Outcome Measures

body weight change (kg) during the 12 week intervention
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)

Secondary Outcome Measures

Food Intake
A 7-day food intake diary (self-reported food intake using household measures) will be completed during the first week of the inclusion phase to allow an assessment of habitual daily energy, macronutrient and fibre intake. Three-day food intake diaries (self-reported food intake using household measures on 2 weekdays and 1 weekend day) will be completed during study weeks 1, 5, 9, 12 and at one year follow up
Glycaemic regulation
This will be assessed using continuous glucose monitoring (CGMS) in a subsample of participants N=24, with N=12 from each treatment arm. Fasting measures of insulin and glucose will be obtained to assess Homeostasis Model Assessment (HOMA) and diabetes risk before and at the end of the intervention
Biochemical measures
Fasting blood samples will be collected during the first week of the intervention and in the last week of the intervention (week 12) on the morning of a test meal challenge day. These fasting samples will be assayed for glucose, insulin, cholesterol, triglycerides and also leptin. These blood samples will be collected at the phlebotomy outpatient clinic at the Leeds General Infirmary. Further blood samples, which will be assayed for appetite hormones (Ghrelin, GLP-1, PYY and CCK), will be taken pre and post lunch on the test meal challenge days via a cannula fitted by a research nurse.
Subjective symptoms, wellbeing and Mood
Each day women will complete a symptom checklist which will ask them to rate a range of symptoms on a five point Likert Scale from 0 (none) to 4 (extreme). The checklist will comprise items relating to women's general wellbeing (e.g. digestive sensations, mood and wellbeing). Women will note down whether they are menstruating. Participants on Diet B will record the amount of fibre they have consumed using a points-based system, as a measure of compliance. Each day all women will be asked to complete the Bristol Stool Form Scale (BSFQ; O'Donnell et al., 1990)
Sleep and body shape perception
Participants will be asked to complete an adapted version of the Leeds Sleep Evaluation Questionnaire (LSEQ; Parrott and Hindmarch, 1978) and Body Shape Questionnaire (BSQ-34; Cooper et al, 1987) during the visits at weeks -1, 4, 12 and at one month and at one year follow up
Eating behaviour
Eating behaviour will be assessed using the Dutch Eating Behaviour Questionnaire (DEBQ; van Strien et al., 1986) and the Three Factor Eating Questionnaire (TFEQ; Stunkard and Messick, 1985) at weeks 1, 4 , 8, 12 and at follow up (one month and one year later) to provide measures of dietary restraint and other psychological aspects of eating behaviour. At follow up (one year later) participants will also be asked to complete the Intuitive Eating Scale (IES; Tylka, 2006) in order to measure the levels of intuitive eating behaviour
Diet Satisfaction
The Diet Satisfaction questionnaire (D-SAT; Ello-Martin et al., 2004) to assess participants satisfaction with their current diet
Depression Anxiety and Stress
The Depression Anxiety Stress Scale (DAAS42; Lovibond and Lovibond,1995) will be used to assess depression anxiety and stress at one year follow up in order to assess symptoms of depression, anxiety and stress.
Life events
Participants will be asked to complete the Social Readjustment Rating Scale (SRRS) also known as Life Events Scale (LES; Holmes and Rahe, 1967) in order to assess stressful events that they may have experienced over the last 12 months
Dietary fibre intake
Participants will be asked to complete the Dietary Instrument for Nutrition Education (DINE; Roe et al., 1994) and the Leeds Women's Wellbeing Fibre Intake Assessment (LWW-FIA) to assess habitual fibre intake catergorically (DINE) and in grams/day (LWW-FIA)
body composition
Body composition will be measured four times using ADP (BodPod, Concord, CA, USA), once during the inclusion phase (week -1), once during the last week of the intervention (week 12) and at follow up (one month and one year later). Body composition will also be measured six times using bioimpedance (Tanita, Illinois, USA) at the inclusion phase (week -1), at weeks 4, 8, 12 of the intervention and at follow up (one month later and one year later).
Waist circumference
Waist circumference will be taken six times according to established methods (Van der Kooy and Seidell, 1993) during the inclusion phase (week -1), at weeks 4,8,12 of the intervention and at follow up (one month later and one year later).
Appetite ratings
100mm Visual Analogue Scale (VAS) ratings of subjective motivation to eat (hunger, fullness, desire to eat and prospective consumption) were completed before and 4 times after a fixed energy lunch meal during the first week of the intervention and then again at the end of the intervention
Food preferences
The Food Preference Checklist (FPC; Blundell and Rogers, 1980) will be completed before and immediately after consumption of the fixed energy test meal

Full Information

First Posted
December 2, 2011
Last Updated
May 21, 2014
Sponsor
University of Leeds
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1. Study Identification

Unique Protocol Identification Number
NCT01539369
Brief Title
The Leeds Women's Wellbeing (LWW) Study
Acronym
LWW
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

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leeds

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
Keywords
dietary intervention, dietary fibre, weight loss, weight maintenance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High fibre diet
Arm Type
Experimental
Arm Title
Healthy eating diet
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Healthy eating diet (Diet A) or healthy eating diet combined with advice to increase fibre intake (Diet B) to at least 25g/day
Intervention Description
Participants were randomly assigned to one of two parallel arms: Diet A:healthy eating without extra advice to increase fibre intake or Diet B: healthy eating with extra advice to increase fibre intake to a minimum of 25g/d. Healthy eating advice was based on the British Heart Foundation booklet: "Food Should Be Fun And Healthy". Participants following Diet A were encouraged to eat breakfast cereals and were provided with complementary cereals and snacks low in fibre. Participants following Diet B were encouraged to eat high fibre breakfast cereals and to incorporate wheat bran fibre in other meals. Complementary high fibre cereals and snacks were provided.
Primary Outcome Measure Information:
Title
body weight change (kg) during the 12 week intervention
Description
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)
Time Frame
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 Outcome Measure Information:
Title
Food Intake
Description
A 7-day food intake diary (self-reported food intake using household measures) will be completed during the first week of the inclusion phase to allow an assessment of habitual daily energy, macronutrient and fibre intake. Three-day food intake diaries (self-reported food intake using household measures on 2 weekdays and 1 weekend day) will be completed during study weeks 1, 5, 9, 12 and at one year follow up
Time Frame
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
Title
Glycaemic regulation
Description
This will be assessed using continuous glucose monitoring (CGMS) in a subsample of participants N=24, with N=12 from each treatment arm. Fasting measures of insulin and glucose will be obtained to assess Homeostasis Model Assessment (HOMA) and diabetes risk before and at the end of the intervention
Time Frame
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)
Title
Biochemical measures
Description
Fasting blood samples will be collected during the first week of the intervention and in the last week of the intervention (week 12) on the morning of a test meal challenge day. These fasting samples will be assayed for glucose, insulin, cholesterol, triglycerides and also leptin. These blood samples will be collected at the phlebotomy outpatient clinic at the Leeds General Infirmary. Further blood samples, which will be assayed for appetite hormones (Ghrelin, GLP-1, PYY and CCK), will be taken pre and post lunch on the test meal challenge days via a cannula fitted by a research nurse.
Time Frame
at baseline (first week of the intervention) and then at baseline +12 weeks (last week of the intervention)
Title
Subjective symptoms, wellbeing and Mood
Description
Each day women will complete a symptom checklist which will ask them to rate a range of symptoms on a five point Likert Scale from 0 (none) to 4 (extreme). The checklist will comprise items relating to women's general wellbeing (e.g. digestive sensations, mood and wellbeing). Women will note down whether they are menstruating. Participants on Diet B will record the amount of fibre they have consumed using a points-based system, as a measure of compliance. Each day all women will be asked to complete the Bristol Stool Form Scale (BSFQ; O'Donnell et al., 1990)
Time Frame
Wellbeing Diary Booklets (WDBs) will be completed each day from screening till the last week of the intervention (week 12)
Title
Sleep and body shape perception
Description
Participants will be asked to complete an adapted version of the Leeds Sleep Evaluation Questionnaire (LSEQ; Parrott and Hindmarch, 1978) and Body Shape Questionnaire (BSQ-34; Cooper et al, 1987) during the visits at weeks -1, 4, 12 and at one month and at one year follow up
Time Frame
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
Title
Eating behaviour
Description
Eating behaviour will be assessed using the Dutch Eating Behaviour Questionnaire (DEBQ; van Strien et al., 1986) and the Three Factor Eating Questionnaire (TFEQ; Stunkard and Messick, 1985) at weeks 1, 4 , 8, 12 and at follow up (one month and one year later) to provide measures of dietary restraint and other psychological aspects of eating behaviour. At follow up (one year later) participants will also be asked to complete the Intuitive Eating Scale (IES; Tylka, 2006) in order to measure the levels of intuitive eating behaviour
Time Frame
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
Title
Diet Satisfaction
Description
The Diet Satisfaction questionnaire (D-SAT; Ello-Martin et al., 2004) to assess participants satisfaction with their current diet
Time Frame
at baseline +12 months
Title
Depression Anxiety and Stress
Description
The Depression Anxiety Stress Scale (DAAS42; Lovibond and Lovibond,1995) will be used to assess depression anxiety and stress at one year follow up in order to assess symptoms of depression, anxiety and stress.
Time Frame
at baseline +12 months
Title
Life events
Description
Participants will be asked to complete the Social Readjustment Rating Scale (SRRS) also known as Life Events Scale (LES; Holmes and Rahe, 1967) in order to assess stressful events that they may have experienced over the last 12 months
Time Frame
at baseline +12 months
Title
Dietary fibre intake
Description
Participants will be asked to complete the Dietary Instrument for Nutrition Education (DINE; Roe et al., 1994) and the Leeds Women's Wellbeing Fibre Intake Assessment (LWW-FIA) to assess habitual fibre intake catergorically (DINE) and in grams/day (LWW-FIA)
Time Frame
at recruitment visit, at baseline +12 weeks, at baseline +16 weeks and at baseline +12 months
Title
body composition
Description
Body composition will be measured four times using ADP (BodPod, Concord, CA, USA), once during the inclusion phase (week -1), once during the last week of the intervention (week 12) and at follow up (one month and one year later). Body composition will also be measured six times using bioimpedance (Tanita, Illinois, USA) at the inclusion phase (week -1), at weeks 4, 8, 12 of the intervention and at follow up (one month later and one year later).
Time Frame
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
Title
Waist circumference
Description
Waist circumference will be taken six times according to established methods (Van der Kooy and Seidell, 1993) during the inclusion phase (week -1), at weeks 4,8,12 of the intervention and at follow up (one month later and one year later).
Time Frame
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
Title
Appetite ratings
Description
100mm Visual Analogue Scale (VAS) ratings of subjective motivation to eat (hunger, fullness, desire to eat and prospective consumption) were completed before and 4 times after a fixed energy lunch meal during the first week of the intervention and then again at the end of the intervention
Time Frame
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)
Title
Food preferences
Description
The Food Preference Checklist (FPC; Blundell and Rogers, 1980) will be completed before and immediately after consumption of the fixed energy test meal
Time Frame
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise Dye, Professor
Organizational Affiliation
University of Leeds
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Psychological Sciences
City
Leeds
ZIP/Postal Code
LS2 9JT
Country
United Kingdom

12. IPD Sharing Statement

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The Leeds Women's Wellbeing (LWW) Study

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