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

May 31, 2017 updated by: Dr Graham Finlayson, University of Leeds

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS2 9JT
        • University of Leeds

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Participants enrolled in commercial weight management program
Behavioral: Weight management program
Active Comparator: Control group
Participants enrolled in standard care weight management provision
Behavioral: Weight management program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test Meal Energy Intake
Time Frame: Week 0 and week 12
Measured reductions in ad-libitum energy intake following consumption of formulated test meal in comparison to control.
Week 0 and week 12
24h Energy Intake
Time Frame: Week 0 and week 12
Measured reduction in total within-day energy intake following consumption of formulated meals in comparison to control
Week 0 and week 12
Appetite sensations
Time Frame: Week 0 and week 14
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
Food preference
Time Frame: Week 0 and week 14
Measured changes in food preference and liking and wanting profiles for food (HF<LF) following consumption of formulated test meal in comparison to equi-energetic control
Week 0 and week 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight
Time Frame: Weekly from week 0 to week 12
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food diary
Time Frame: Week 0 and week 12
Intervention adherence and compensation through 1) food diary analysis.
Week 0 and week 12
Accelerometer
Time Frame: Week 0 and week 12
Intervention adherence and compensation through accelerometer analysis.
Week 0 and week 12
Interview
Time Frame: Week 12
Detailed feedback on participant experience of commercial weight management program through qualitative interview and marketing survey.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leeds

Investigators

  • Principal Investigator: Graham S Finlayson, PhD, University of Leeds

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (Estimate)

December 16, 2013

Study Record Updates

Last Update Posted (Actual)

June 1, 2017

Last Update Submitted That Met QC Criteria

May 31, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LDS-2013-SLW
  • KRISTAL No. (Other Identifier: RG.PSYC.100944)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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