INAPEN Protocol for Impact of Breakfast Improvement (INAPEN)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Hospital undernutrition is a common health problem [1]. As a countermeasure, French hospitals have created a system of cross-function committees for feeding and nutrition called CLANs [Comité de Liaison pour l'alimentation et la nutrition] [2]. Potential actions for improving patient nutritional status include improving the characteristics of the food provided to increase both protein and calorie intake in at-risk patients that do not require enteral or parenteral nutrition. Looking at the various daily meals, the investigators considered that breakfast following the night fast would be the easiest meal to improve .

Condition Intervention Phase Patients scheduled for hospitalization of over 4 days Addition of protein (milky food in the breakfast) Current care

Condition or disease	Intervention/treatment	Phase
Hospital Undernutrition; Malnutrition; Nutritional Deficiency	Dietary Supplement: Addition of protein (milky food in the breakfast)	Not Applicable

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	800 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	INAPEN Protocol for Impact of Breakfast Improvement on the Nutritional Status of Hospitalized Patients (INcidence de l'Amélioration du Petit-déjeuner Sur l'Etat Nutritinonel Des Patients hospitalisés)
Study Start Date :	October 2009
Estimated Primary Completion Date :	June 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Sham Comparator: Observational period; A first period of follow-up on the 400 patients was designed to survey and evaluate current nutrition administration policy	Dietary Supplement: Addition of protein (milky food in the breakfast); The main purpose of this study is to evaluate the efficacy of additional protein (adding milky food to the breakfast) in order to deliver an optimized protein and energy intake of 15.75 g and 559 Kcal, respectively.
Experimental: Intervention period; The second period of follow-up on the 400 patients was designed to evaluate the impacts of adding milky food to the breakfast and of educating health care professionals on the early detection of undernutrition.	Dietary Supplement: Addition of protein (milky food in the breakfast); The main purpose of this study is to evaluate the efficacy of additional protein (adding milky food to the breakfast) in order to deliver an optimized protein and energy intake of 15.75 g and 559 Kcal, respectively.

Outcome Measures

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Primary Outcome Measures :

1. serum transthyretin (prealbumin) concentration [ Time Frame: changes between D0 to D7 between the 2 cohorts ]
   Improvement of serum transthyretin (prealbumin) concentration changes between D0 to D7

Secondary Outcome Measures :

1. serum albumin concentration changes and length of stay [ Time Frame: Changes between the 2 cohorts ]
   serum albumin concentration changes between D0 to D7, length of stay

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Patients hospitalized for 8 days or more in the participant wards and capable of eating the proposed breakfast.

According to the current care procedure, patients receiving an information document and offered the possibility of refusal.

Exclusion Criteria:

• End of life defined as an absence of curative treatment (limitation of care)
• Enteral or parenteral nutrition
• Need for limitations on oral nutrition (i.e. post-surgery)

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Xavier Forceville, MD, PhD	164351176 ext 33	x-forceville@ch-meaux.fr
Contact: François Thuillier, PD	164351106 ext 33	f-thuillier@ch-meaux.fr

Locations

France
Centre Hospitalier de Meaux	Recruiting
Meaux, France, 77
Contact: Xavier Forceville, MD, PhD 164351176 ext 33 x-forceville@ch-meaux.fr
Contact: François Thuillier, PD 164351106 ext 33 f-thuillier@ch-meaux.fr
Principal Investigator: Xavier Forceville, MD, PhD
Sub-Investigator: Samia Touati, MD
Sub-Investigator: Karell Prieux - Lucas, Dietitian

Sponsors and Collaborators

Centre Hospitalier de Meaux

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Rapport complet de l'ANAES :Evaluation diagnostique de la dénutrition protéino-énergétique des adultes hospitalises. September 2003; http://www.has-sante.fr

Reilly JJ Jr, Hull SF, Albert N, Waller A, Bringardener S. Economic impact of malnutrition: a model system for hospitalized patients. JPEN J Parenter Enteral Nutr. 1988 Jul-Aug;12(4):371-6.

Circulaire DHOS/E1 N°2002-186 29/03/2002 relative à l'alimentation et la nutrition dans les établissements de santé: J off de la République Française 18/04/2002

Kudsk KA, Tolley EA, DeWitt RC, Janu PG, Blackwell AP, Yeary S, King BK. Preoperative albumin and surgical site identify surgical risk for major postoperative complications. JPEN J Parenter Enteral Nutr. 2003 Jan-Feb;27(1):1-9.

Edington J, Boorman J, Durrant ER, Perkins A, Giffin CV, James R, Thomson JM, Oldroyd JC, Smith JC, Torrance AD, Blackshaw V, Green S, Hill CJ, Berry C, McKenzie C, Vicca N, Ward JE, Coles SJ. Prevalence of malnutrition on admission to four hospitals in England. The Malnutrition Prevalence Group. Clin Nutr. 2000 Jun;19(3):191-5.

Somanchi M, Tao X, Mullin GE. The facilitated early enteral and dietary management effectiveness trial in hospitalized patients with malnutrition. JPEN J Parenter Enteral Nutr. 2011 Mar;35(2):209-16. doi: 10.1177/0148607110392234.

Responsible Party:	Xavier Forceville, MD, PhD, CHdMeaux
ClinicalTrials.gov Identifier:	NCT01342861 History of Changes
Other Study ID Numbers:	INAPEN
First Posted:	April 27, 2011
Last Update Posted:	April 27, 2011
Last Verified:	April 2011

Keywords provided by Centre Hospitalier de Meaux:

protein supplementation; caloric intake; breakfast	transthyretin (prealbumin); albumin; Length of stay

Additional relevant MeSH terms:

Malnutrition; Nutrition Disorders