Overview

This trial is active, not recruiting.

Conditions overweight, obesity, sedentary lifestlye
Treatment weight management program
Sponsor University of Leeds
Start date January 2014
End date December 2015
Trial size 80 participants
Trial identifier NCT02012426, KRISTAL No., LDS-2013-SLW

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose basic science
Arm
(Experimental)
Participants enrolled in commercial weight management program
weight management program
(Active Comparator)
Participants enrolled in standard care weight management provision
weight management program

Primary Outcomes

Measure
Test Meal Energy Intake
time frame: Week 0 and week 12
24h Energy Intake
time frame: Week 0 and week 12
Appetite sensations
time frame: Week 0 and week 14
Food preference
time frame: Week 0 and week 14

Secondary Outcomes

Measure
Body Weight
time frame: Weekly from week 0 to week 12

Eligibility Criteria

Female participants from 18 years up to 65 years old.

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

Additional Information

Official title The Effect of a Multi-component Weight Management Program on Appetite, Food Preference and Body Weight
Principal investigator Graham S Finlayson, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University of Leeds.