Weight LossLWWNCT01539369
The Leeds Women's Wellbeing (LWW) Study
A study testing Healthy eating diet (Diet A) or healthy eating diet combined with advice to increase fibre intake (Diet B) to at least 25g/day in people with Weight Loss, run by University of Leeds at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Healthy eating diet (Diet A) or healthy eating diet combined with advice to increase fibre intake (Diet B) to at least 25g/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2011to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Psychological Sciences
Leeds, LS2 9JT
About this 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
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).
Read the 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.
- Conditions
- Weight Loss
- Being tested
- Healthy eating diet (Diet A) or healthy eating diet combined with advice to increase fibre intake (Diet B) to at least 25g/day
- Keywords
- dietary intervention, dietary fibre, weight loss, weight maintenance
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy eating diet (Diet A) or healthy eating diet combined with advice to increase fibre intake (Diet B) to at least 25g/dayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| High fibre diet | Experimental | Not described Receives: Other: Healthy eating diet (Diet A) or healthy eating diet combined with advice to increase fibre intake (Diet B) to at least 25g/day |
| Healthy eating diet | Active comparator | Not described Receives: Other: Healthy eating diet (Diet A) or healthy eating diet combined with advice to increase fibre intake (Diet B) to at least 25g/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 (14)
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
Measured: 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
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
Measured: 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
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.
Measured: at baseline (first week of the intervention) and then at baseline +12 weeks (last week of the intervention)
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)
Measured: 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
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
Measured: 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
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
Measured: 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
The Diet Satisfaction questionnaire (D-SAT; Ello-Martin et al., 2004) to assess participants satisfaction with their current diet
Measured: at baseline +12 months
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.
Measured: at baseline +12 months
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
Measured: at baseline +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)
Measured: at recruitment visit, at baseline +12 weeks, at baseline +16 weeks and at baseline +12 months
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).
Measured: 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
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).
Measured: 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
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
Measured: 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
The Food Preference Checklist (FPC; Blundell and Rogers, 1980) will be completed before and immediately after consumption of the fixed energy test meal
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startApr 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Louise Dye, University of Leeds
- Investigators
- Louise Dye, Professor, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539369
- Sponsor's protocol ID
- 10/H1305/6
- Acronym
- LWW
- Status last verified
- May 2014
- First submitted
- 2 Dec 2011
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01539369
- Acronym / sponsor ID
- LWW / 10/H1305/6
- Conditions
- Weight Loss
- Keywords
- dietary intervention, dietary fibre, weight loss, weight maintenance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 27 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High fibre diet | Experimental | Other: Healthy eating diet (Diet A) or healthy eating diet combined with advice to increase fibre intake (Diet B) to at least 25g/day |
| Healthy eating diet | Active comparator | Other: Healthy eating diet (Diet A) or healthy eating diet combined with advice to increase fibre intake (Diet B) to at least 25g/day |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy eating diet (Diet A) or healthy eating diet combined with advice to increase fibre intake (Diet B) to at least 25g/dayParticipants 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. | Other | Healthy eating diet, High fibre diet |
Primary outcome
body weight change (kg) during the 12 week intervention
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
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)
14 secondary outcomes
Food Intake
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
Glycaemic regulation
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)
Biochemical measures
Time frame: at baseline (first week of the intervention) and then at baseline +12 weeks (last week of the intervention)
Subjective symptoms, wellbeing and Mood
Time frame: 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
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
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
Diet Satisfaction
Time frame: at baseline +12 months
Depression Anxiety and Stress
Time frame: at baseline +12 months
Life events
Time frame: at baseline +12 months
Dietary fibre intake
Time frame: at recruitment visit, at baseline +12 weeks, at baseline +16 weeks and at baseline +12 months
body composition
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
Waist circumference
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
Appetite ratings
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)
Food preferences
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise Dye, Professor principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy eating diet (Diet A) or healthy eating diet combined with advice to increase fibre intake (Diet B) to at least 25g/day in people with Weight Loss, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body weight change (kg) during the 12 week intervention (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2014.