How does the step counter, which was used as a motivational and monitoring tool for increasing physical activity in the lifestyle intervention program, impact on physical activity and glycemic control among type 2 diabetes patients when compared with being used only for counting steps or not being used in the control arm?
Relevant articles were identified by electronic searches of PubMed, Web of Science and Cochrane Library databases from 1994 to June 2013.
In consultation with a medical research librarian, MeSH term as “diabetes mellitus” and text words as “pedomet*” or “acceleromet*” or “step counter” were combined for search in Pubmed, and the search strategy was adapted for other databases.
English-language randomized controlled trials were eligible for inclusion.
Types of study to be included
We will include randomized controlled trials to assess the effectiveness of a step counter use in increasing physical activity and improving glycemic control.
Condition or domain being studied
Physical activity in outpatient type 2 diabetes
Inclusion: Outpatients with Type 2 diabetes
Exclusion: Type 1 diabetes, Gestational diabetes, Inpatients with Type 1, Type 2 or Gestational diabetes, or outpatients with impaired glucose tolerance.
Inclusion: Step counters, such as pedometers and accelerometers, were used as motivational and step counting tools for increasing physical activity in a lifestyle intervention program, in which sometimes also contained step goals, diaries, counseling and education. A reported change in number of steps per day (steps/d) or glycosylated hemoglobin A1c (HbA1c), or both, should also be necessary.
Exclusion: Step counters were used only for counting steps or monitoring walking speed (such as steps per minute) in the intervention program. Or there was no reported change in steps/d or HbA1c.
We will include control groups with usual care (no step counter intervention), or with step counters only for counting steps.
The most important outcomes are steps/d and HbA1c.
Steps/d will be calculated mainly by pedometer.
Risk of bias (quality) assessment
Data from included RCTs will be checked for: missing data and internal data consistency.
Quality assessment form will be developed to assess the risk of bias of included studies, which form will be based on the template suggested by Centre for Review and Dissemination (CRD) for systematic reviews in their guidelines. All of these will be independently done by 2 authors.
Discrepancies over the risk of bias in particular studies will be resolved by discussion or consensus.
Sensitivity analyses will be applied to test the effect of removing each study in the synthesis.
Strategy for data synthesis
We will provide a descriptive synthesis from the eligible studies including study characteristics (authors and publication year), numbers of participants, and details of the intervention and control groups. We will also provide summaries of intervention effects (Steps/d and HbA1c) for each study by calculating wighted mean differences.
All summary estimates were analyzed with a random-effects model. Cochran Q test was used to assess heterogeneity among studies, with a threshold P value of 0.1 being considered statistically significant. The degree of inconsistency among trails was estimated using the I-square test, where an I-square value greater than 50% was considered to be of substantial heterogeneity. Heterogeneity was explored with three strategies. First, sensitivity analyses were conducted by removing each study individually to check whether a particular study could explain heterogeneity. Second, univariate meta-regression analyses were performed to assess whether the clinical or methodological variables could influence the outcome estimates. Third, subgroup analyses were carried out based on meta-regression analyses and prespecified relevant study characteristics. Publication bias was detected and evaluated by Begg's test and Egger's test.
Analysis of subgroups or subsets
We anticipate that subgroup analyses will be done based on meta-regression analyses and prespecified relevant study characteristics, such as sample size, intervention duration, diary use, goal setting and the quality score.
Contact details for further information
Xinmofan Road No.3, Nanjing, China
Organisational affiliation of the review
Zhongda Hospital, Southeast University, China
Mr Shanhu Qiu, Ms Xue Cai, Professor Zilin Sun, Mrs Xiang Chen, Bingquan Yang,
Mr Bingquan Yang,
Anticipated or actual start date
06 August 2013
Anticipated completion date
31 October 2013
This study was funded by the Key Program of Jiangsu Natural Science Foundation (BK 2010087).
Conflicts of interest
Subject index terms status
Subject indexing assigned by CRD
Subject index terms
Diabetes Mellitus; Exercise; Humans; Hypoglycemia; Leisure Activities; Motor Activity; Self Care
Stage of review
Completed but not published
Date of registration in PROSPERO
31 July 2013
Date of publication of this revision
15 January 2014
Stage of review at time of this submission
Piloting of the study selection process
Formal screening of search results against eligibility criteria
Risk of bias (quality) assessment
PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites.