Nutrition, HealthyNCT05140330
Improving Nutrition and Physical Activity in the Elderly Living at Home - ALAPAGE Study
A study testing ALAPAGE workshop in people with Nutrition, Healthy, run by Observatoire Regional de la Sante Provence-Alpes-Côte d'Azur at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- ALAPAGE workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Jan 2022to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 60 years of age or older
- Live at home
- Understand French
- Be a beneficiary of a French social insurance scheme
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Asept Paca
Marseille, 13008
Mutualité française Sud
Marseille, 13016
About this study
Official title: French Tittle : Recherche Visant à améliorer l'ALimentation et l'Activité Physique du Sujet AGE Vivant à Domicile - Etude ALAPAGE
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.
Read more
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.
- Conditions
- Nutrition, Healthy
- Being tested
- ALAPAGE workshop, control workshop
- Keywords
- Elderly, Dietary diversity, Lifestyle integrated Functional Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALAPAGE workshopBehavioural
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 workshopBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 7 ALAPAGE sessions over 2 months and 1 evaluation session at 3 months Receives: Behavioral: ALAPAGE workshop |
| Control | Other | 3 evaluation sessions over 2 months and 1 session at 3 months Receives: Behavioral: control workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dietary diversity
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).
Measured: First session, last session and 3 months after the last session, in both intervention and control participants
Change in lower limb muscle strength
Assessed by a professional in adapted physical activity using the 30s chair-stand test (from the Senior Fitness Test)
Measured: First session and 3 months after the last session, in both intervention and control participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start13 Jan 2022
- Primary completion21 Sep 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Observatoire Regional de la Sante Provence-Alpes-Côte d'Azur
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, University of Avignon, University of Bordeaux, Caisse d'assurance retraite et santé au travail du Sud-Est, Mutualité Française Sud, Association santé éducation et prévention sur les territoires de Paca, Institut de Recherche en Santé Publique, France, Agence Régionale de Santé Provence-Alpes-Côte d'Azur
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140330
- Sponsor's protocol ID
- 2020-A03151-38
- Status last verified
- Feb 2024
- First submitted
- 4 Nov 2021
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Jacquemot AF, Cogordan C, Fressard L, Maradan G, Riabi C, Bocquier A, Trehard H, Hervieu V, Dubois C, Danthony S, Verger P, Darmon N, Vinet A. Effects of a combined diet and physical activity intervention (the ALAPAGE program) on dietary diversity and lower-limb muscle strength in community-dwelling older people: a pragmatic randomized controlled trial. BMC Geriatr. 2026 Jul 22;26(1):1331. doi: 10.1186/s12877-026-07999-2.
PubMed 42907749Jacquemot AF, Bocquier A, Vinet A, Dubois C, Darmon N, Gelie FC, Feart C, Verger P, Danthony S; ALAPAGE Study Group. Intervention Mapping: A Framework to Co-Design the ALAPAGE Programme to Simultaneously Improve Dietary Diversity and Physical Fitness Among Older People. Health Expect. 2026 Apr;29(2):e70612. doi: 10.1111/hex.70612.
PubMed 41869742Bocquier 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.
PubMed 35927684
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Tittle : Recherche Visant à améliorer l'ALimentation et l'Activité Physique du Sujet AGE Vivant à Domicile - Etude ALAPAGE
- ClinicalTrials.gov ID
- NCT05140330
- Acronym / sponsor ID
- 2020-A03151-38
- Conditions
- Nutrition, Healthy
- Keywords
- Elderly, Dietary diversity, Lifestyle integrated Functional Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Observatoire Regional de la Sante Provence-Alpes-Côte d'AzurUniversity, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, University of Avignon, University of Bordeaux, Caisse d'assurance retraite et santé au travail du Sud-Est, Mutualité Française Sud, Association santé éducation et prévention sur les territoires de Paca, Institut de Recherche en Santé Publique, France, Agence Régionale de Santé Provence-Alpes-Côte d'Azur
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: ALAPAGE workshop7 ALAPAGE sessions over 2 months and 1 evaluation session at 3 months |
| Control | Other | Behavioral: control workshop3 evaluation sessions over 2 months and 1 session at 3 months |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be 60 years of age or older
- Live at home
- Understand French
- Be a beneficiary of a French social insurance scheme
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALAPAGE workshop7 weekly group sessions over 2 months (1 introduction session, 2 physical activity sessions and 4 nutrition sessions) and 1 evaluation session at 3 months | Behavioural | Intervention |
| control workshop3 evaluation group sessions over 2 months and 1 session at 3 months. After those 4 sessions, the participants will benefit from an ALAPAGE workshop | Behavioural | Control |
Primary outcome
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).
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- BackgroundPrat,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
- Derived from this study: PubMed 42907749Jacquemot AF, Cogordan C, Fressard L, Maradan G, Riabi C, Bocquier A, Trehard H, Hervieu V, Dubois C, Danthony S, Verger P, Darmon N, Vinet A. Effects of a combined diet and physical activity intervention (the ALAPAGE program) on dietary diversity and lower-limb muscle strength in community-dwelling older people: a pragmatic randomized controlled trial. BMC Geriatr. 2026 Jul 22;26(1):1331. doi: 10.1186/s12877-026-07999-2.
- Derived from this study: PubMed 41869742Jacquemot AF, Bocquier A, Vinet A, Dubois C, Darmon N, Gelie FC, Feart C, Verger P, Danthony S; ALAPAGE Study Group. Intervention Mapping: A Framework to Co-Design the ALAPAGE Programme to Simultaneously Improve Dietary Diversity and Physical Fitness Among Older People. Health Expect. 2026 Apr;29(2):e70612. doi: 10.1111/hex.70612.
- Derived from this study: PubMed 35927684Bocquier 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALAPAGE workshop in people with Nutrition, Healthy, run by Observatoire Regional de la Sante Provence-Alpes-Côte d'Azur at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dietary diversity (time frame: First session, last session and 3 months after the last session, in both intervention and control participants). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05140330, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.