The Effect of a Multi-component Weight Management Program on Appetite, Food Preference and Body Weight

Obesity Clinical Trial

— SWSS  

Official title:

The Effect of a Multi-component Weight Management Program on Appetite, Food Preference and Body Weight

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02012426
• Other study ID #: LDS-2013-SLW
• Secondary ID: KRISTAL No.
• Status: Completed
• Phase: N/A
• First received: December 10, 2013
• Last updated: May 31, 2017
• Start date: January 2014
• Est. completion date: May 2016

Study information

• Verified date: May 2017
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the current study is to demonstrate that a commercial weight management diet (i.e. low energy density) influences satiation, hunger and satiety and leads to lower energy intake during ad-libitum meals and over a full day. We further seek to demonstrate the sustainability of this effect following 12- week weight loss on the weight management program.

• We hypothesise that formulated (low energy) meals will lead to decreased hunger, greater fullness and reduced desire to eat compared to standard meals.

• We hypothesise that the commercial weight management program will lead to greater weight loss compared to control program.

• We hypothesise that formulated meals (high consumer acceptance) will improve hedonic control over eating (lower wanting for high fat food)

• We hypothesise that the commercial weight management program will improve hedonic control over eating (reduced experience food cravings)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI of 28 - 45 kg/m2

• Reporting an interest in weight loss, not actively participating in a commercial weight loss program,

• Not increased physical activity levels in the past 2-4 weeks

• Able to eat most everyday foods and fruits and vegetables

• Written informed consent to be given

Exclusion Criteria:

• Significant health problems that could cause confounding effects between intervention and control.

• Taking any medication or supplements known to affect appetite or weight within the past month and/or during the study

• Pregnant, planning to become pregnant or breastfeeding

• History of anaphylaxis to food

• Known food allergies or food intolerance

• Smokers and those who have recently ceased smoking

• Participants receiving systemic or local treatment likely to interfere with evaluation of the study parameters

• Those who have previously taken part in a commercial weight loss program in the last 6 months? .

• Participants who work in appetite or feeding related areas

• Participants unable to consume foods used in the study

• Participants who have had bariatric surgery

• Participants with a history of eating disorder

• Presence of untreated hypothyroidism

• Inability to fully comply with intervention or study procedures

• Insufficient English language skills to complete study questionnaires

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight
• Sedentary Lifestlye

Intervention

Behavioral:
• Weight management program

Locations

Country	Name	City	State
United Kingdom	University of Leeds	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Leeds

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Food diary	Intervention adherence and compensation through 1) food diary analysis.	Week 0 and week 12
Other	Accelerometer	Intervention adherence and compensation through accelerometer analysis.	Week 0 and week 12
Other	Interview	Detailed feedback on participant experience of commercial weight management program through qualitative interview and marketing survey.	Week 12
Primary	Test Meal Energy Intake	Measured reductions in ad-libitum energy intake following consumption of formulated test meal in comparison to control.	Week 0 and week 12
Primary	24h Energy Intake	Measured reduction in total within-day energy intake following consumption of formulated meals in comparison to control	Week 0 and week 12
Primary	Appetite sensations	Measured reduction in hunger and increase in satiety quotient following consumption of formulated test meal in comparison to equi-energetic control	Week 0 and week 14
Primary	Food preference	Measured changes in food preference and liking and wanting profiles for food (HF	Week 0 and week 14
Secondary	Body Weight	Measured change in weight and energy balance parameters over a 12 week period following participation in commercial weight management program compared to control group.	Weekly from week 0 to week 12