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

NCT ID: NCT02012426

Last Updated: 2017-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-05-31

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)

Conditions

Overweight; Obesity; Sedentary Lifestlye

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

Participants enrolled in commercial weight management program

Group Type: EXPERIMENTAL

Weight management program

Intervention Type: BEHAVIORAL

Control group

Participants enrolled in standard care weight management provision

Group Type: ACTIVE_COMPARATOR

Weight management program

Intervention Type: BEHAVIORAL

Interventions

Weight management program

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Leeds

OTHER

Sponsor Role: lead

Responsible Party

Dr Graham Finlayson

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Graham S Finlayson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Leeds

Locations

University of Leeds

Leeds, West Yorkshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 31340872 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30053284 (View on PubMed)

Other Identifiers

KRISTAL No.

Identifier Type: OTHER

Identifier Source: secondary_id

LDS-2013-SLW

Identifier Type: -

Identifier Source: org_study_id