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NCT Number: NCT05140330

Improving Nutrition and Physical Activity in the Elderly Living at Home - ALAPAGE Study

CONTEXT Promoting healthy aging and preventing loss of autonomy are critical issues for many countries. In France, the 2018-2022 national health strategy emphasizes that adequate nutrition and regular physical activity are key elements of healthy aging. Numerous prevention interventions to improve diet and physical activity in older adults exist in France and abroad, but very few have been evaluated. The ALAPAGE1 prefiguration study revealed a large number of preventive nutrition activities for seniors in Southeastern France, mainly as group prevention workshops. This study showed the need to i) improve the participation of socially isolated and/or economically vulnerable seniors in these workshops to avoid increasing social inequalities in health; ii) improve the form and content of the workshops and harmonize practices; and iii) evaluate the impact of these workshops. A strong partnership dynamic between our research teams and key players in the field of nutrition prevention for seniors has been initiated. It has enabled the co-construction of ALAPAGE project.

OBJECTIVES The main objective is to assess the impact of an improved prevention offer, the ALAPAGE group workshops, on the eating behaviors and physical activity of seniors living at home.

The secondary objectives are as follows:

* To assess the impact of seniors participation in the workshop on their feelings of loneliness and on their quality of life; * To assess the mechanisms by which participation in a group workshop on diet and physical activity improves dietary diversity, physical ability and quality of life of participants, the acceptability of this workshop, the levers they activate and the psychosocial determinants of behaviour (intention, attitude, subjective norms, perceived control).

METHODS ALAPAGE workshops will be set up in local structures that usually receive elderly subjects for this type of activity. These workshops will be led by dieticians and professionals in adapted physical activity according to a protocol and with harmonized tools.

The intervention will take place according to the following phasing:

* Recruitment of the structures in which the 45 ALAPAGE workshops will take place * Randomization of the workshops * 30 Intervention workshops: 7 ALAPAGE sessions over 2 months and 1 evaluation session at 3 months * 15 Control workshops: 3 evaluation sessions over 2 months and 1 session at 3 months * Recruitment of 10 participants per workshop To answer the main objective, a dietary diversity score and the lower limb muscle strength will be assessed at the first session, the last session and 3 months after the last session, in both intervention and control participants. Others data will be collected throughout the workshop.

EXPECTED BENEFITS If the results of this research provide proof of concept that the prevention nutrition strategy based on ALAPAGE workshop, makes it possible, in the French context, to improve dietary diversity core and strength, this will constitute knowledge of major public utility. Participants will benefit from a personalized assessment of the diversity of their diet and their functional physical capacities and receive information and advice to adapt their diet and physical activity.

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Key information

Conditions

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asept Paca, Marseille, France

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Be 60 years of age or older
  • Live at home
  • Understand French
  • Be a beneficiary of a French social insurance scheme

Exclusion criteria

  • Receive a personalized autonomy allowance.
  • Have already participated in a preventive nutrition/physical activity workshop during the previous two years;
  • Be under guardianship or curatorship.

Treatment and study plan

ALAPAGE workshop

Behavioral

7 weekly group sessions over 2 months (1 introduction session, 2 physical activity sessions and 4 nutrition sessions) and 1 evaluation session at 3 months

control workshop

Behavioral

3 evaluation group sessions over 2 months and 1 session at 3 months. After those 4 sessions, the participants will benefit from an ALAPAGE workshop

Primary outcomes

  1. Change in dietary diversity

    Time frame: First session, last session and 3 months after the last session, in both intervention and control participants

    Dietary diversity is assessed with the Diversity ALAPAGE Score (DAS). The DAS is calculated as follows: Consumption occurrences of 20 ALAPAGE food categories are reported from two 24H recall (for food eaten every day such as fruits, vegetables, meat excluding poultry, sweetened products, … ) and from a Food Frequency Questionnaire (FFQ, for foods which are consumed less often such as eggs, legumes, nuts, fatty fish, lean fish, and wholegrain cereals). According to the nutritional quality of its food category, each consumption earns negative or positive points. The DAS for one individual is the sum of all attributed points. A higher score means a greater dietary diversity. The DAS was recently applied to the dietary data of adults aged 60 years.old and over in a representative sample of the French population, and the distribution of the DAS was as follows: minimum = -40 ; mean = 53 ; maximum = 112 (Prat et al, 2021).

  2. Change in lower limb muscle strength

    Time frame: First session and 3 months after the last session, in both intervention and control participants

    Assessed by a professional in adapted physical activity using the 30s chair-stand test (from the Senior Fitness Test)

Sponsors and collaborators

Lead sponsor

Observatoire Regional de la Sante Provence-Alpes-Côte d'Azur

Other

Collaborators

  • Agence Régionale de Santé Provence-Alpes-Côte d'Azur
  • Association santé éducation et prévention sur les territoires de Paca
  • Caisse d'assurance retraite et santé au travail du Sud-Est
  • Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
  • Institut de Recherche en Santé Publique, France
  • Mutualité Française Sud
  • University of Avignon
  • University of Bordeaux

Registry information

Official study title

French Tittle : Recherche Visant à améliorer l'ALimentation et l'Activité Physique du Sujet AGE Vivant à Domicile - Etude ALAPAGE

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Dec 1, 2021
Registry last updated
Feb 20, 2024

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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