Evidence map›Paper›PMID 34496859›Full record

Trial reportThe international journal of behavioral nutrition and physical activity2021

Effects of a three-armed randomised controlled trial using self-monitoring of daily steps with and without counselling in prediabetes and type 2 diabetes-the Sophia Step Study.

Jenny Rossen, Kristina Larsson, Maria Hagströmer, Agneta Yngve, Kerstin Brismar, Barbara Ainsworth, Linda Åberg, Unn-Britt Johansson

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The international journal of behavioral nutrition and physical activity, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02374788 (Health Promotion in the Primary Care Setting- an Evaluation of the Sophia Step Study- a Structured Behaviour Change Program Focusing on Physical Activity in Persons With Pre- and Type 2 Diabetes), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT02374788 nacompletednot on this map

Health Promotion in the Primary Care Setting- an Evaluation of the Sophia Step Study- a Structured Behaviour Change Program Focusing on Physical Activity in Persons With Pre- and Type 2 Diabetes

TypeinterventionalSponsorSophiahemmet UniversityRan2013 to 2020Enrolled188ConditionsType 2 Diabetes, PrediabetesArmsPedometer intervention, Group meetings, Individual consultations
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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.

Jenny RossenDepartment of Health Promoting Science, Sophiahemmet University, Stockholm, Sweden. Jenny.rossen@shh.se.ORCID 0000-0003-4920-252X
Kristina LarssonDepartment of Health Promoting Science, Sophiahemmet University, Stockholm, Sweden.
Maria HagströmerDepartment of Health Promoting Science, Sophiahemmet University, Stockholm, Sweden.
Agneta YngveDepartment of Nutrition, Dietetics and Food Studies, Uppsala University, Uppsala, Sweden.
Kerstin BrismarDepartment of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.
Barbara AinsworthSchool of Kinesiology, Shanghai University of Sport, Shanghai, China.
Linda ÅbergSmedby Primary Care Center, Kalmar, Sweden.
Unn-Britt JohanssonDepartment of Health Promoting Science, Sophiahemmet University, Stockholm, Sweden.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis aimed to evaluate the effects of self-monitoring of daily steps with or without counselling support on HbA1c, other cardiometabolic risk factors and objectively measured physical activity (PA) during a 2-year intervention in a population with prediabetes or type 2 diabetes.

methodsThe Sophia Step Study was a three-armed parallel randomised controlled trial. Participants with prediabetes or type 2 diabetes were recruited in a primary care setting. Allocation (1:1:1) was made to a multi-component intervention (self-monitoring of steps with counselling support), a single-component intervention (self-monitoring of steps without counselling support) or standard care. Data were collected for primary outcome HbA1c at baseline and month 6, 12, 18 and 24. Physical activity was assessed as an intermediate outcome by accelerometer (ActiGraph GT1M) for 1 week at baseline and the 6-, 12-, 18- and 24-month follow-up visits. The intervention effects were evaluated by a robust linear mixed model.

resultsIn total, 188 subjects (64, 59, 65 in each group) were included. The mean (SD) age was 64 (7.7) years, BMI was 30.0 (4.4) kg/m

conclusionThis 2-year intervention, including self-monitoring of steps with or without counselling, prevented a decrease in PA but did not provide evidence for improved metabolic control and cardiometabolic risk factors in a population with prediabetes or type 2 diabetes.

trial registrationClinicalTrials.gov, NCT02374788 . Registered 2 March 2015-Retrospectively registered.

Indexed as

Diabetes Mellitus, Type 2Prediabetic StateCounselingExerciseFemaleHumansMiddle AgedPrimary Health CareActivity trackerBehaviourCardiometabolic risk factorsHbA1cPedometerPhysical activityStep counter

Identifiers

PMID34496859
PMCPMC8424865

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Registered trials

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.