Evidence map›Paper›PMID 36943335›Full record

ArticleJMIR research protocols2023

Effects of a Salutogenic Healthy Eating Program in Type 2 Diabetes (the SALUD Study): Protocol for a Randomized Controlled Trial.

Kristel C M M Polhuis, Lenneke Vaandrager, Maria A Koelen, Johanna M Geleijnse, Sabita S Soedamah-Muthu

Abstract read
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Article in JMIR research protocols, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

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2citing papers in PubMed
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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

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4 · The record

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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Kristel C M M PolhuisHealth & Society, Wageningen University & Research, Wageningen, Netherlands.ORCID https://orcid.org/0000-0002-8122-676X
Lenneke VaandragerHealth & Society, Wageningen University & Research, Wageningen, Netherlands.ORCID https://orcid.org/0000-0003-2805-7423
Maria A KoelenHealth & Society, Wageningen University & Research, Wageningen, Netherlands.ORCID https://orcid.org/0000-0001-6516-8638
Johanna M GeleijnseDivision of Human Nutrition and Health, Wageningen University & Research, Wageningen, Netherlands.ORCID https://orcid.org/0000-0001-7638-0589
Sabita S Soedamah-MuthuDepartment of Medical and Clinical Psychology, Center of Research on Psychological disorders and Somatic diseases (CoRPS), Tilburg University, Tilburg, Netherlands.ORCID https://orcid.org/0000-0002-8830-3502

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHealthy eating can improve the course of type 2 diabetes mellitus (T2DM) considerably. As changing eating behaviors in everyday is challenging, there is a need for a nutritional strategy with an eye for everyday life of people with T2DM. A theory centered around the everyday life context is salutogenesis. Salutogenic principles have been operationalized in a new nutritional program for T2DM on food literacy and well-being: the Salutogenic Intervention for Type 2 Diabetes (SALUD) program.

objectiveThis study aims to describe the protocol of the invention study that will examine the quantitative and qualitative effects of the SALUD program.

methodsA semiblinded randomized controlled trial will be performed in the Netherlands. A sample size of 56 (including a 30% dropout rate) people with T2DM has been calculated, of whom half (n=28, 50%) will follow the SALUD program (intervention) and half (n=28, 50%) will receive usual care (control). Recruitment strategies consist of advertisement via local health care professionals, posters, social media, and local newspapers. The SALUD program consists of 12 weekly web-based group sessions under the supervision of a certified lifestyle coach. Fidelity of the delivery is guaranteed by selecting a salutogenic coach, use of an intervention manual, training of the coach, weekly evaluation forms, and recording several sessions. The theoretical salutogenic principle of the intervention is mobilizing 2 important psychosocial resources required for organizing healthy eating in everyday life: self-identity and social support. Measurements will be performed at 3 times: at baseline (T0), after 12 weeks (postintervention; T1), and after 24 weeks (follow-up; T2). The primary outcome is food literacy, measured with the self-perceived food literacy scale questionnaire (expected effect size=0.9). Secondary outcomes are self-efficacy, quality of life, sense of coherence, diet quality, body weight, BMI, and waist-hip ratio. All outcomes will be tested with linear mixed models, following an intention-to-treat approach and standard principles of randomized controlled trials. In addition, a qualitative analysis will be performed.

resultsThe proposed study will provide useful information on the effects of a salutogenic program on healthy eating and well-being in people with T2DM in everyday life. Recruitment started on October 1, 2021. The intervention participants followed the SALUD program between January and August, 2022. The acquisition of the data was completed on August 1, 2022; publications are expected in 2023.

conclusionsThis study will be one of the first salutogenic interventions for T2DM, which will provide valuable information on what salutogenic intervention entail. The SALUD program may serve as a concrete, web-based tool. The combination of quantitative and qualitative measures allows a comprehensive evaluation of effects. These insights can be used for further optimalization of T2DM interventions.

trial registrationNetherlands Trial Registry, NL8963; https://trialsearch.who.int/Trial2.aspx?TrialID=NL8963. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40490.

Indexed as

diabetes type 2empowermentlifestylenutritional interventionpatient centeredrandomized controlled trialRCTresiliencesalutogenesis

Identifiers

PMID36943335
PMCPMC10131793

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.