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Completed

NCT Number: NCT02012426

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

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)

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Sedentary Lifestlye Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight management program

Behavioral

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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.

Other outcomes

  1. Food diary

    Time frame: Week 0 and week 12

    Intervention adherence and compensation through 1) food diary analysis.

  2. Accelerometer

    Time frame: Week 0 and week 12

    Intervention adherence and compensation through accelerometer analysis.

  3. Interview

    Time frame: Week 12

    Detailed feedback on participant experience of commercial weight management program through qualitative interview and marketing survey.

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Registry information

Acronym: SWSS

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 16, 2013
Registry last updated
Jun 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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