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- Ensaio Clínico NCT02012426
The Effect of a Multi-component Weight Management Program on Appetite, Food Preference and Body Weight (SWSS)
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)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
West Yorkshire
-
Leeds, West Yorkshire, Reino Unido, LS2 9JT
- University of Leeds
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Intervention Group
Participants enrolled in commercial weight management program
|
|
|
Comparador Ativo: Control group
Participants enrolled in standard care weight management provision
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Test Meal Energy Intake
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Body Weight
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Food diary
Prazo: Week 0 and week 12
|
Intervention adherence and compensation through 1) food diary analysis.
|
Week 0 and week 12
|
|
Accelerometer
Prazo: Week 0 and week 12
|
Intervention adherence and compensation through accelerometer analysis.
|
Week 0 and week 12
|
|
Interview
Prazo: Week 12
|
Detailed feedback on participant experience of commercial weight management program through qualitative interview and marketing survey.
|
Week 12
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Graham S Finlayson, PhD, University of Leeds
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- LDS-2013-SLW
- KRISTAL No. (Outro identificador: RG.PSYC.100944)
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