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

Primary Purpose

Overweight, Obesity, Sedentary Lifestlye

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Weight management program
Sponsored by
University of Leeds
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Leeds

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control group

Arm Description

Participants enrolled in commercial weight management program

Participants enrolled in standard care weight management provision

Outcomes

Primary Outcome Measures

Test Meal Energy Intake
Measured reductions in ad-libitum energy intake following consumption of formulated test meal in comparison to control.
24h Energy Intake
Measured reduction in total within-day energy intake following consumption of formulated meals in comparison to control
Appetite sensations
Measured reduction in hunger and increase in satiety quotient following consumption of formulated test meal in comparison to equi-energetic control
Food preference
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

Secondary Outcome Measures

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.

Full Information

First Posted
December 10, 2013
Last Updated
May 31, 2017
Sponsor
University of Leeds
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1. Study Identification

Unique Protocol Identification Number
NCT02012426
Brief Title
The Effect of a Multi-component Weight Management Program on Appetite, Food Preference and Body Weight
Acronym
SWSS
Official Title
The Effect of a Multi-component Weight Management Program on Appetite, Food Preference and Body Weight
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leeds

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Sedentary Lifestlye

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Participants enrolled in commercial weight management program
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants enrolled in standard care weight management provision
Intervention Type
Behavioral
Intervention Name(s)
Weight management program
Primary Outcome Measure Information:
Title
Test Meal Energy Intake
Description
Measured reductions in ad-libitum energy intake following consumption of formulated test meal in comparison to control.
Time Frame
Week 0 and week 12
Title
24h Energy Intake
Description
Measured reduction in total within-day energy intake following consumption of formulated meals in comparison to control
Time Frame
Week 0 and week 12
Title
Appetite sensations
Description
Measured reduction in hunger and increase in satiety quotient following consumption of formulated test meal in comparison to equi-energetic control
Time Frame
Week 0 and week 14
Title
Food preference
Description
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
Time Frame
Week 0 and week 14
Secondary Outcome Measure Information:
Title
Body Weight
Description
Measured change in weight and energy balance parameters over a 12 week period following participation in commercial weight management program compared to control group.
Time Frame
Weekly from week 0 to week 12
Other Pre-specified Outcome Measures:
Title
Food diary
Description
Intervention adherence and compensation through 1) food diary analysis.
Time Frame
Week 0 and week 12
Title
Accelerometer
Description
Intervention adherence and compensation through accelerometer analysis.
Time Frame
Week 0 and week 12
Title
Interview
Description
Detailed feedback on participant experience of commercial weight management program through qualitative interview and marketing survey.
Time Frame
Week 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graham S Finlayson, PhD
Organizational Affiliation
University of Leeds
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Leeds
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS2 9JT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31340872
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.
Results Reference
derived
PubMed Identifier
30053284
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.
Results Reference
derived

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

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