The Leeds Women's Wellbeing (LWW) Study

NCT ID: NCT01539369

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-01-31

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.

Conditions

Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

High fibre diet

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Leeds

OTHER

Sponsor Role: lead

Responsible Party

Prof Louise Dye

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louise Dye, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Leeds

Locations

Institute of Psychological Sciences

Leeds, , United Kingdom

Countries

United Kingdom

Other Identifiers

10/H1305/6

Identifier Type: -

Identifier Source: org_study_id