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Relationship between baseline physical activity assessed by pedometer count and new-onset diabetes in the NAVIGATOR trial.

ABSTRACT: Physical activity is related to clinical outcomes, even after adjusting for body mass, but is rarely assessed in randomized clinical trials.We conducted an observational analysis of data from the Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research trial, in which a total of 9306 people from 40 countries with impaired glucose tolerance and either cardiovascular disease or cardiovascular risk factors were randomized to receive nateglinide or placebo, in a 2-by-2 factorial design with valsartan or placebo. All were asked to also participate in a detailed lifestyle modification programme and followed-up for a median of 6.4 years with progression to diabetes as a co-primary end point. Seven-day ambulatory activity was assessed at baseline using research-grade pedometers. We assessed whether the baseline amount of physical activity was related to subsequent development of diabetes in individuals with impaired glucose tolerance.Pedometer data were obtained on 7118 participants and 35.0% developed diabetes. In an unadjusted analysis each 2000-step increment in the average number of daily steps, up to 10 000, was associated with a 5.5% lower risk of progression to diabetes (HR 0.95, 95%CI 0.92 to 0.97), with >6% relative risk reduction after adjustment.Physical activity should be measured objectively in pharmacologic trials as it is a significant but underappreciated contributor to diabetes outcomes. It should be a regular part of clinical practice as well.

SUBMITTER: Kraus WE

PROVIDER: S-EPMC6067333 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Relationship between baseline physical activity assessed by pedometer count and new-onset diabetes in the NAVIGATOR trial.

Kraus William E WE Yates Thomas T Tuomilehto Jaakko J Sun Jie-Lena JL Thomas Laine L McMurray John J V JJV Bethel M Angelyn MA Holman Rury R RR

BMJ open diabetes research & care 20180719 1

<h4>Objective</h4>Physical activity is related to clinical outcomes, even after adjusting for body mass, but is rarely assessed in randomized clinical trials.<h4>Research design and methods</h4>We conducted an observational analysis of data from the Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research trial, in which a total of 9306 people from 40 countries with impaired glucose tolerance and either cardiovascular disease or cardiovascular risk factors were randomized to rec ...[more]

PMID: 30073088

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Project description:BackgroundThe European pedometer-based "10,000 Steps Ghent" whole community intervention for 228,000 residents was found to be effective in increasing step counts by an average of 896 steps/day in a sub-sample of adults. The present study aimed to examine the characteristics of intervention participants (n = 438) who (1) used a pedometer and (2) increased their step counts. Additionally, the third aim was to examine the mediational effect of pedometer use on step count change.MethodsThe study sample consisted of 438 adults (207 male, mean age 49.8 (13.1) years). Binary logistic regressions were used to examine whether individual characteristics (gender, age, educational level, employment status, self-reported health condition, baseline step counts, baseline sitting time, baseline transport-related PA) and intervention exposure variables (having heard/seen a PA promotion message, being aware of the PA guidelines, and knowing about "10,000 Steps Ghent") were associated with (1) pedometer use and (2) a step count increase of 896 steps/day or more. Using pooled data (n = 864) from the intervention and comparison participants, a mediation analysis was conducted to see if the change in step counts was mediated by pedometer use.ResultsAge (49 years or more: OR = 3.19, p < 0.005), awareness of a PA promotion message (OR = 2.62, p < 0.01) and awareness of "10,000 Steps Ghent" (OR = 2.11, p < 0.05) were significantly associated with pedometer use. Participants with a college or university degree (OR = 1.55, p < 0.05) and those who used a pedometer (OR = 2.06, p < 0.05) were more likely to increase their steps by 896 steps/day or more. This increase was less likely among those with baseline step counts above 10,000 steps/day (OR = 0.38, p < 0.001). The mediation analysis revealed that pedometer use partly mediated step count change.ConclusionPedometer use was more likely in older participants and in those who were aware of the "10,000 Steps" campaign. Increasing step counts was more likely among those with higher education, baseline step counts below 10,000 steps/day and those who used a pedometer. Pedometer use only partly mediated the intervention effect on step counts.

Dataset Information

Relationship between baseline physical activity assessed by pedometer count and new-onset diabetes in the NAVIGATOR trial.

Publications

Relationship between baseline physical activity assessed by pedometer count and new-onset diabetes in the NAVIGATOR trial.

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