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

NCT ID: NCT05140330

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-13

Study Completion Date

2024-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Nutrition, Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

7 ALAPAGE sessions over 2 months and 1 evaluation session at 3 months

Group Type EXPERIMENTAL

ALAPAGE workshop

Intervention Type 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

3 evaluation sessions over 2 months and 1 session at 3 months

Group Type OTHER

control workshop

Intervention Type 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

Interventions

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ALAPAGE workshop

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

Intervention Type BEHAVIORAL

control workshop

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

OTHER

Sponsor Role collaborator

University of Avignon

OTHER

Sponsor Role collaborator

University of Bordeaux

OTHER

Sponsor Role collaborator

Caisse d'assurance retraite et santé au travail du Sud-Est

UNKNOWN

Sponsor Role collaborator

Mutualité Française Sud

UNKNOWN

Sponsor Role collaborator

Association santé éducation et prévention sur les territoires de Paca

UNKNOWN

Sponsor Role collaborator

Institut de Recherche en Santé Publique, France

OTHER

Sponsor Role collaborator

Agence Régionale de Santé Provence-Alpes-Côte d'Azur

UNKNOWN

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Asept Paca

Marseille, , France

Site Status

Mutualité française Sud

Marseille, , France

Site Status

Countries

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France

References

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Prat,R., Gazan,R., Jacquemot, A.-F., Dubois, C., Feart,C., Darmon, N., Verger.E. Évaluation de la validité du score de diversité ALAPAGE avec des indicateurs de qualité nutritionnelle de l'alimentation de seniors en France (INCA3). Abstract JFN 2021

Reference Type BACKGROUND

Bocquier A, Jacquemot AF, Dubois C, Trehard H, Cogordan C, Maradan G, Cortaredona S, Fressard L, Davin-Casalena B, Vinet A, Verger P, Darmon N; ALAPAGE Study Group; Arquier V, Briclot G, Chamla R, Cousson-Gelie F, Danthony S, Delrieu K, Dessirier J, Feart C, Fusinati C, Gazan R, Gibert M, Lamiraud V, Maillot M, Nadal D, Trotta C, Verger EO, Viriot V. Study protocol for a pragmatic cluster randomized controlled trial to improve dietary diversity and physical fitness among older people who live at home (the "ALAPAGE study"). BMC Geriatr. 2022 Aug 4;22(1):643. doi: 10.1186/s12877-022-03260-8.

Reference Type DERIVED
PMID: 35927684 (View on PubMed)

Other Identifiers

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2020-A03151-38

Identifier Type: -

Identifier Source: org_study_id

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