Clinical trial NCT02012426: The Effect of a Multi-component Weight Management Program on Appetite, Food Preference and Body Weight
Official title: The Effect of a Multi-component Weight Management Program on Appetite, Food Preference and Body Weight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Sedentary Lifestlye
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2013-12-16
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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)


Eligibility criteria: 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

Primary outcomes:
measure: Test Meal Energy Intake
timeFrame: Week 0 and week 12
measure: 24h Energy Intake
timeFrame: Week 0 and week 12
measure: Appetite sensations
timeFrame: Week 0 and week 14
measure: Food preference
timeFrame: Week 0 and week 14
Secondary outcomes:
measure: Body Weight
timeFrame: Weekly from week 0 to week 12
Other outcomes:
measure: Food diary
timeFrame: Week 0 and week 12
measure: Accelerometer
timeFrame: Week 0 and week 12
measure: Interview
timeFrame: Week 12
Locations:
city: Leeds
country: United Kingdom
facility: University of Leeds
state: West Yorkshire
Study officials:
affiliation: University of Leeds
name: Graham S Finlayson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buckland NJ, Camidge D, Croden F, Myers A, Lavin JH, Stubbs RJ, Blundell JE, Finlayson G. Women with a low-satiety phenotype show impaired appetite control and greater resistance to weight loss. Br J Nutr. 2019 Oct 28;122(8):951-959. doi: 10.1017/S000711451900179X.
citation: Buckland NJ, Camidge D, Croden F, Lavin JH, Stubbs RJ, Hetherington MM, Blundell JE, Finlayson G. A Low Energy-Dense Diet in the Context of a Weight-Management Program Affects Appetite Control in Overweight and Obese Women. J Nutr. 2018 May 1;148(5):798-806. doi: 10.1093/jn/nxy041.