The Leeds Women's Wellbeing (LWW) Study

NCT01539369 | Completed

• 1 other identifier: 10/H1305/6
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Weight Loss

Keywords

dietary intervention; dietary fibre; weight loss; weight maintenance

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  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

Study Arms (2)

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

Interventions

Healthy eating diet (Diet A) or healthy eating diet combined with advice to increase fibre intake (Diet B) to at least 25g/day OTHER

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.

Healthy eating diet; High fibre diet

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

Institute of Psychological Sciences

Leeds, LS2 9JT, United Kingdom

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Louise Dye, Professor

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 2, 2011
• First Posted: February 27, 2012
• Study Start: April 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

GB (1)