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Do Weight Status and the Level of Dietary Restraint Moderate the Relationship Between Package Unit Size and Food Intake?

3 aprile 2018 aggiornato da: Hollie Raynor, The University of Tennessee, Knoxville
The objective of this study is to determine the independent and combined effects of weight status and the level of dietary restraint on the relationship between package unit size and food intake.

Panoramica dello studio

Descrizione dettagliata

The estimated prevalence of obesity among adults in 2007-2008 was 33.8% and the combined estimated prevalence of overweight and obesity was 68.0% [1]. Although there are no clear reasons for the current obesity epidemic, there is a general consensus that environmental dietary factors, such as package unit size, encourage excessive food intake and positive energy balance [2, 3]. It is believed that the package unit size of food indirectly influences food intake by impacting the accuracy of consumption monitoring [2, 4]. Large packages decrease the accuracy of consumption monitoring by making it difficult to assess how many servings have been consumed in one sitting, while small single-serving packages can increase the accuracy of consumption monitoring by providing a clear definition of what a standard serving is and how much one has consumed [2, 4, 5]. Therefore, it has been proposed that small, single-serving packages of snack foods may help reduce energy intake [4, 5]. To date, limited studies have been conducted in this area and the results are inconsistent [4-9]. Mixed results could be related to differences in participant variables, specifically weight status and level of dietary restraint (a term that refers to the amount of control exerted over food intake) [4, 9]. These individual characteristics may interact with food package unit size to influence one's food intake [2, 4]. Overweight individuals or restrained eaters may more closely monitor the volume of food they consume as compared to normal weight or unrestrained eaters [4, 9]. The [smaller] size of food packaging may aid in monitoring food consumption and thus, influence how much food is consumed in overweight and/or restrained eaters [2, 4]. Therefore, the objective of this study is to determine if weight status and the level of dietary restraint moderate the relationship between package unit size and food intake.

Specific Aims:

  1. Determine the effect of dietary restraint on the relationship between package unit size and food intake.
  2. Determine the effect of weight status on the relationship between package unit size and food intake.
  3. Determine the combined effect of weight status and dietary restraint on the relationship between package unit size and food intake.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

64

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Tennessee
      • Knoxville, Tennessee, Stati Uniti, 37996
        • Healthy Eating and Activity Laboratory

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 35 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Male and females aged 18-35 years old.
  • Body Mass Index (BMI) between 18.5-24.9 kg/m2 or BMI between 25-39.9 kg/m2.

    • For normal weight groups: BMI of 18.5-24.9 kg/m2.
    • For overweight groups: BMI of 25-39.9 kg/m2.
  • Dietary restraint scores of either less than or equal to 12 or > 12 on the Three Factor Eating Questionnaire-Cognitive Restraint scale (TFEQ-R) [10].

    • For unrestrained groups: less than or equal to 12.
    • For restrained groups: > 12.
  • Do not have unfavorable preference toward pretzels.
  • Do not have allergies to pretzel ingredients.
  • Do not have a health condition or use medication that affects eating or requires a therapeutic diet.
  • Must have a consistent schedule during the time of the study.
  • Must agree to instructions to not share pretzel snack packages with others.

Exclusion Criteria:

  • BMI below 18.5 or above 39.9 kg/m2.
  • Have an unfavorable preference toward pretzels.
  • Have allergies to pretzel ingredients (wheat flour).

    • Severe allergies to nuts - Synder's of Hanover pretzels are made in a facility that handles peanut butter.
  • Are unwilling to consume pretzels during the time of the study.
  • Are pregnant or breastfeeding.
  • Do not meet one or more of the other above mentioned eligibility requirements.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Normal Weight, Unrestrained - Standard
Each participant is of normal weight (BMI: 18.5-24.9 kg/m2) and is classified as an unrestrained eater (scoring less than or equal to 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
Participants will receive a box of two, 10-oz. packages of pretzels. Participants will receive the box of pretzels in the lab on a Thursday or Friday and will take the box of pretzels home for a period of four days. Participants will bring back the box of pretzels to the lab on the following Monday or Tuesday (depending on the day of the initial receipt of pretzels).
Comparatore attivo: Normal Weight, Restrained - Single Serving
Each participant is of normal weight (BMI: 18.5-24.9 kg/m2) and is classified as a restrained eater (scoring greater than 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
Participants will receive a box of twenty-two, 0.9-oz. packages of pretzels. Participants will receive the box of pretzels in the lab on a Thursday or Friday and will take the box of pretzels home for a period of four days. Participants will bring back the box of pretzels to the lab on the following Monday or Tuesday (depending on the day of the initial receipt of pretzels).
Comparatore attivo: Normal Weight, Restrained - Standard
Each participant is of normal weight (BMI: 18.5-24.9 kg/m2) and is classified as a restrained eater (scoring greater than 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
Participants will receive a box of two, 10-oz. packages of pretzels. Participants will receive the box of pretzels in the lab on a Thursday or Friday and will take the box of pretzels home for a period of four days. Participants will bring back the box of pretzels to the lab on the following Monday or Tuesday (depending on the day of the initial receipt of pretzels).
Comparatore attivo: Overweight, Unrestrained - Single Serving
Each participant is overweight (BMI: 25-39.9 kg/m2) and is classified as an unrestrained eater (scoring less than or equal to 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
Participants will receive a box of twenty-two, 0.9-oz. packages of pretzels. Participants will receive the box of pretzels in the lab on a Thursday or Friday and will take the box of pretzels home for a period of four days. Participants will bring back the box of pretzels to the lab on the following Monday or Tuesday (depending on the day of the initial receipt of pretzels).
Comparatore attivo: Overweight, Unrestrained - Standard
Each participant is overweight (BMI: 25-39.9 kg/m2) and is classified as an unrestrained eater (scoring less than or equal to 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
Participants will receive a box of two, 10-oz. packages of pretzels. Participants will receive the box of pretzels in the lab on a Thursday or Friday and will take the box of pretzels home for a period of four days. Participants will bring back the box of pretzels to the lab on the following Monday or Tuesday (depending on the day of the initial receipt of pretzels).
Comparatore attivo: Overweight, Restrained - Single Serving
Each participant is overweight (BMI: 25-39.9 kg/m2) and is classified as a restrained eater (scoring greater than 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
Participants will receive a box of twenty-two, 0.9-oz. packages of pretzels. Participants will receive the box of pretzels in the lab on a Thursday or Friday and will take the box of pretzels home for a period of four days. Participants will bring back the box of pretzels to the lab on the following Monday or Tuesday (depending on the day of the initial receipt of pretzels).
Comparatore attivo: Overweight, Restrained - Standard
Each participant is overweight (BMI: 25-39.9 kg/m2) and is classified as a restrained eater (scoring greater than 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
Participants will receive a box of two, 10-oz. packages of pretzels. Participants will receive the box of pretzels in the lab on a Thursday or Friday and will take the box of pretzels home for a period of four days. Participants will bring back the box of pretzels to the lab on the following Monday or Tuesday (depending on the day of the initial receipt of pretzels).
Comparatore attivo: Normal Weight, Unrestrained - Single Serving
Each participant is of normal weight (BMI: 18.5-24.9 kg/m2) and is classified as an unrestrained eater (scoring less than or equal to 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
Participants will receive a box of twenty-two, 0.9-oz. packages of pretzels. Participants will receive the box of pretzels in the lab on a Thursday or Friday and will take the box of pretzels home for a period of four days. Participants will bring back the box of pretzels to the lab on the following Monday or Tuesday (depending on the day of the initial receipt of pretzels).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Total grams of pretzels consumed.
Lasso di tempo: 4 days
Total grams of pretzels consumed by participants over the 4-day study period will be determined by subtracting pre- and post-consumption weight of snack packages provided.
4 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Hollie A Raynor, Ph.D., University of Tennessee, Knoxville
  • Investigatore principale: Chrystal L Haire, B.S., University of Tennessee, Knoxville

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2011

Completamento primario (Effettivo)

1 ottobre 2011

Completamento dello studio (Effettivo)

1 ottobre 2011

Date di iscrizione allo studio

Primo inviato

25 giugno 2011

Primo inviato che soddisfa i criteri di controllo qualità

27 giugno 2011

Primo Inserito (Stima)

29 giugno 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 aprile 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 aprile 2018

Ultimo verificato

1 aprile 2018

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 8573 B

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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