The Leeds Women's Wellbeing (LWW) Study

Browse trials for

• Weight Loss 1,766

Keywords

• dietary intervention
• dietary fibre
• weight loss
• weight maintenance

Weight Loss

1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.

This study's enrollment of 80 is close to the median of 73 across 1,496 interventional studies indexed under Weight Loss.

Lead sponsor

University of Leeds is the lead sponsor of 200 studies on the registry; 25 are open to participants now.

Study arms

• Experimental
  High fibre diet

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

• Active comparator
  Healthy eating diet

  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

• OtherHealthy 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.

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)

   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 outcomes

1. 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

   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

2. 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

   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)

3. 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.

   Time frame: at baseline (first week of the intervention) and then at baseline +12 weeks (last week of the intervention)

4. 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)

   Time frame: Wellbeing Diary Booklets (WDBs) will be completed each day from screening till the last week of the intervention (week 12)

5. 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

   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

6. 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

   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

7. Diet Satisfaction

   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

8. 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.

   Time frame: at baseline +12 months

9. 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

   Time frame: at baseline +12 months

10. 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)

    Time frame: at recruitment visit, at baseline +12 weeks, at baseline +16 weeks and at baseline +12 months

11. 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).

    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

12. 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).

    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

13. 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

    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)

14. 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

    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)