Evidence map›Paper›PMID 26695176›Full record

Trial reportBMC family practice2015

Effects of a lifestyle program in subjects with Impaired Fasting Glucose, a pragmatic cluster-randomized controlled trial.

Arlette E Hesselink, Guy E H Rutten, Sander M Slootmaker, Inge de Weerdt, Lieke G M Raaijmakers, Ruud Jonkers, Marloes K Martens, Henk J G Bilo

Open access · goldAbstract readRandomized Controlled TrialPragmatic Clinical Trial
In one paragraph

Trial report in BMC family practice, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
1.8field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

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

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 15 citations in OpenAlex.

  1. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Observational
  7. Review
  8. Article
  9. Article
  10. Article
  11. Review
4 · The record

Corrections and comments

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

8 authors at 3 institutions in 1 country.

Arlette E HesselinkResCon, Research & Consultancy, Kennemerplein 7, 2011 MH, Haarlem, The Netherlands. A.Hesselink@rescon.nl.
Guy E H RuttenJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Sander M SlootmakerNetherlands Diabetes Federation, Amersfoort, The Netherlands.
Inge de WeerdtNetherlands Diabetes Federation, Amersfoort, The Netherlands.
Lieke G M RaaijmakersDepartment of Health Promotion, NUTRIM School for Nutrition, Toxicology and Metabolism, Maastricht University Medical Centre, Maastricht, The Netherlands.
Ruud JonkersResCon, Research & Consultancy, Kennemerplein 7, 2011 MH, Haarlem, The Netherlands.
Marloes K MartensResCon, Research & Consultancy, Kennemerplein 7, 2011 MH, Haarlem, The Netherlands.
Henk J G BiloDiabetes Centre and Department of Internal Medicine, Isala Clinics, Zwolle; and, University Medical Centre Groningen, Groningen, The Netherlands.
Isala · NLMaastricht University Medical Centre · NLUniversity Medical Center Utrecht · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe worldwide epidemic of type 2 diabetes (T2DM) underlines the need for diabetes prevention strategies. In this study the feasibility and effectiveness of a nurse led lifestyle program for subjects with impaired fasting glucose (IFG) is assessed.

methodsA cluster randomized clinical trial in 26 primary care practices in the Netherlands included 366 participants older than 45 years with newly diagnosed IFG and motivated to change their lifestyle (intervention group, n = 197; usual care group, n = 169). The one-year intervention, consisting of four to five individual nurse-led consultations, was directed at improving physical activity and dietary habits. The primary outcome measure was body mass index (BMI). Linear and logistic multilevel analyses and a process evaluation were performed.

resultsBoth groups showed small reductions in BMI at 1 and 2 years, but differences between groups were not significant. At both 1 and 2-year follow-up the number of participants physically active for at least 30 minutes at least five days a week was significantly improved in the intervention group compared to the usual care group (intervention group vs. usual care group: OR1year = 3.53; 95 % CI = 1.69-7.37 and OR2years = 1.97; 95 % CI = 1.22-3.20, respectively). The total drop-out rate was 24 %. Process evaluation revealed that participants in the intervention group received fewer consultations than advised, while some practice nurses and participants considered the RM protocol too intensive.

conclusionsThis relatively simple lifestyle program in subjects with IFG resulted in a significant improvement in reported physical activity, but not in BMI. Despite its simplicity, some participants still considered the intervention too intensive. This viewpoint could be related to poor motivation and an absence of disease burden due to IFG, such that participants do not feel a need for behavioural change. Although the intervention provided some benefit, its wider use cannot be advised.

trial registrationCurrent Controlled Trials ISRCTN41209683 , date of registration 16/10/2013h  .

Indexed as

FastingLife StyleAgedBlood GlucoseBody Mass IndexFemaleFollow-Up StudiesHumansIncidenceMaleMiddle AgedNetherlandsPrediabetic StatePrimary Health CareBlood Glucose

Identifiers

PMID26695176
PMCPMC4688978
OpenAlexW2209526697

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.