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")

Abstract

Background: Diet and physical activity are key components of healthy aging. Current interventions that promote healthy eating and physical activity among the elderly have limitations and evidence of French interventions' effectiveness is lacking. We aim to assess (i) the effectiveness of a combined diet/physical activity intervention (the "ALAPAGE" program) on older peoples' eating behaviors, physical activity and fitness levels, quality of life, and feelings of loneliness; (ii) the intervention's process and (iii) its cost effectiveness.

Methods: We performed a pragmatic cluster randomized controlled trial with two parallel arms (2:1 ratio) among people ≥60 years old who live at home in southeastern France. A cluster consists of 10 people participating in a "workshop" (i.e., a collective intervention conducted at a local organization). We aim to include 45 workshops randomized into two groups: the intervention group (including 30 workshops) in the ALAPAGE program; and the waiting-list control group (including 15 workshops). Participants (expected total sample size: 450) will be recruited through both local organizations' usual practices and an innovative active recruitment strategy that targets hard-to-reach people. We developed the ALAPAGE program based on existing workshops, combining a participatory and a theory-based approach. It includes a 7-week period with weekly collective sessions supported by a dietician and/or an adapted physical activity professional, followed by a 12-week period of post-session activities without professional supervision. Primary outcomes are dietary diversity (calculated using two 24-hour diet recalls and one Food Frequency Questionnaire) and lower-limb muscle strength (assessed by the 30-second chair stand test from the Senior Fitness Test battery). Secondary outcomes include consumption frequencies of main food groups and water/hot drinks, other physical fitness measures, overall level of physical activity, quality of life, and feelings of loneliness. Outcomes are assessed before the intervention, at 6 weeks and 3 months later. The process evaluation assesses the fidelity, dose, and reach of the intervention as its causal mechanisms (quantitative and qualitative data).

Discussion: This study aims to improve healthy aging while limiting social inequalities. We developed and evaluated the ALAPAGE program in partnership with major healthy aging organizations, providing a unique opportunity to expand its reach.

Trial registration: ClinicalTrials.gov Identifier: NCT05140330 , December 1, 2021.

Protocol version: Version 3.0 (November 5, 2021).

Keywords: Cluster randomized controlled trial; Dietary diversity; Elderly people; Health education; Healthy ageing; Lifestyle integrated functional exercise; Nutrition; Physical activity; Quality of life.

Fig. 1

Schematic overview of the ALAPAGE study. S0-S6: diet and physical activity sessions of the ALAPAGE program; T0-T2: evaluation time points; V0-V3: measurement visits ^aWeek number