Cited by 50Physical Activity and HealthCardiovascular and exercise physiologyDiabetes, Cardiovascular Risks, and Lipoproteins

Relationships of Changes in Physical Activity and Sedentary Behavior With Changes in Physical Fitness and Cardiometabolic Risk Profile in Individuals with Type 2 Diabetes: The Italian Diabetes and Exercise Study 2 (IDES_2)

Open access
Balducci, Stefano, Haxhi, Jonida, Sacchetti, Massimo, Orlando, Giorgio, Cardelli, Patrizia, Vitale, Martina, Mattia, Lorenza, Iacobini, Carla +5 more·2022·Diabetes Care

Published version of a preprint

Abstract

OBJECTIVE: In the Italian Diabetes and Exercise Study_2 (IDES_2), behavioral counseling promoted a sustained increase in physical activity (PA) volume (+3.3 MET h ⋅ week−1), moderate- to vigorous-intensity PA (MVPA) (+6.4 min ⋅ day−1), and light-intensity PA (LPA) (+0.8 h ⋅ day−1) and decrease in sedentary time (SED-time) (−0.8 h ⋅ day−1). Here, we investigated the relationships of changes in PA/SED-time with changes in physical fitness and cardiometabolic risk profile in individuals with type 2 diabetes. RESEARCH DESIGN AND METHODS: In this 3-year randomized clinical trial, 300 physically inactive and sedentary patients were randomized 1:1 to receive 1-month theoretical and practical counseling once a year or standard care. Changes in physical fitness and cardiovascular risk factors/scores according to quartiles of accelerometer-measured changes in PA/SED-time were assessed, together with univariate and multivariable associations between these parameters, in the whole cohort and by study arm. RESULTS: Physical fitness increased and HbA1c and coronary heart disease 10-year risk scores decreased with quartiles of MVPA and SED-time change. In quartile IV of MVPA increase and SED-time decrease, cardiorespiratory fitness increased by 5.23 and 4.49 mL ⋅ min−1 ⋅ kg−1 and HbA1c decreased by 0.73 and 0.85%, respectively. Univariate correlations confirmed these relationships, and mean changes in both MPVA and SED-time predicted changes in physical fitness and cardiovascular risk factors/scores independently of one another and of other confounders. Similar findings were observed with LPA and PA volume and in each group separately. CONCLUSIONS: Even modest increments in MVPA may have a clinically meaningful impact, and reallocating SED-time to LPA may also contribute to improved outcomes, possibly by increasing total energy expenditure.

AI snapshot

Written from the paper’s full text.

TL;DR

In a prespecified ancillary analysis of the 3-year IDES_2 randomized trial, both increases in moderate-to-vigorous physical activity (MVPA) and decreases in sedentary time (SED-time) were associated with improved physical fitness and cardiometabolic risk profile in adults with type 2 diabetes. Even modest MVPA increments appeared clinically meaningful, and reallocating SED-time to light-intensity physical activity (LPA) may also contribute to improved outcomes.

Key findings

  • Physical fitness increased and HbA1c and coronary heart disease (CHD) 10-year risk scores decreased across quartiles of MVPA increase and SED-time decrease.
  • In quartile IV of MVPA increase and SED-time decrease, cardiorespiratory fitness increased by 5.23 and 4.49 mL/min/kg, and HbA1c decreased by 0.73% and 0.85%, respectively.
  • In multivariable models, changes in both MVPA and SED-time independently predicted changes in VO2max and HbA1c; MVPA change also predicted upper- and lower-body strength, waist circumference, triglycerides, and systolic blood pressure, while SED-time change predicted bending, fasting plasma glucose, diastolic blood pressure, HDL cholesterol, and CHD 10-year risk scores.
  • Similar findings were observed for LPA and total PA volume and in each study arm separately.

Methods

  • Prespecified ancillary analysis of IDES_2, an open-label, assessor-blinded, parallel, superiority randomized clinical trial; 300 physically inactive and sedentary patients with type 2 diabetes were randomized 1:1 to behavioral counseling or standard care, with 267 completing the 3-year study.
  • PA/SED-time was measured by accelerometer and daily diary at baseline and every 4 months for 7 consecutive days; physical fitness was assessed yearly, and cardiovascular risk factors and UK Prospective Diabetes Study risk scores were measured.
  • Analyses stratified participants by quartiles of changes in MVPA, SED-time, LPA, and PA volume; used one-way ANOVA and Spearman correlations; and applied multivariable linear regression models including age, sex, study arm, baseline dependent variable, and changes in MVPA/SED-time (model 1), with LPA substituted for SED-time (model 2) and PA volume substituted for MVPA/SED-time (model 3), in the whole cohort and by study arm.

Limitations

  • The paper states that generalizability requires further investigation and validation in different cohorts or settings.
  • The paper states that the trial was not designed to assess the impact of changes in MVPA and SED-time on physical fitness and CVD risk factors/scores, which were secondary end points, and that specific studies should be designed for this purpose.
  • The paper states that results might have been affected by unmeasured confounders, e.g., diet, which were not considered in data analysis, though dietary prescriptions were given and adherence was verified at intermediate visits; evident from the text, analyses were limited to completers (267 of 300) and the open-label design did not blind participants or physicians, though assessors were blinded.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.2337/dc21-1505

Cites

Statistics

Nothing to recompute.

Claims the paper makes

0 of 35 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    Only change in SED-time was an independent predictor of change in bending, FPG, diastolic BP, and CHD 10-year risk scores.

    “Only change in SED-time was an independent predictor of change in bending, FPG, diastolic BP, and CHD 10year risk scores and, inversely, of change in HDL cholesterol (Table 4)”
    Quote in the paperSubstantial claim
  • Findingown data

    Physical fitness improved with quartiles of mean change in MVPA.

    “Improvements with quartiles of mean change over baseline in MVPA were observed for PA/SED-time and physical fitness parameters as well as for HbA 1c , FPG, BMI, triglycerides, and total and fatal CHD 10-year risk (Table 2).”
    Quote in the paperSubstantial claim
  • Findingown data

    HbA1c improved with quartiles of mean change in SED-time.

    “Improvements with quartiles of mean change over baseline in SED-time were observed for PA and physical fitness parameters as well as for HbA 1c and total and fatal CHD 10-year risk (Table 3).”
    Quote in the paperSubstantial claim
  • Findingown data

    Similar findings were observed with LPA and PA volume.

    “Similar findings were observed with LPA and PA volume and in each group separately.”
    Quote in the paperSubstantial claim
  • Findingown data

    In quartile IV of MVPA increase, cardiorespiratory fitness increased by 5.23 mL/min/kg.

    “In quartile IV of MVPA increase and SED-time decrease, cardiorespiratory fitness increased by 5.23 and 4.49 mL Á min 21 Á kg 21 and HbA 1c decreased by 0.73 and 0.85%, respectively.”
    Quote in the paperSubstantial claim
  • May combine two claims. 13
  • Classified as probably not a substantial claim. 9
  • The quote only partly states this claim. 1
  • May combine two claims.

    Findingcitation

    In IDES_2, time spent in MVPA was only ~12 min/day at baseline and increased by >50% throughout the 3-year follow-up, remaining 30% over baseline at end of study.

    “In fact, in the IDES_2, time spent in MVPA was only $12 min Á day À1 at baseline and, hence, increased by >50% throughout the 3-year follow-up and was still 30% over baseline at end of study (13).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [13] Balducci, 2019, Effect of a behavioral intervention strategy on sustained change in physical activity and sedentary behavior in patients with type 2 diabetes: the IDES_2 randomized clinical trial, JAMA source

      Not checked in the free run.

  • May combine two claims.

    Findingown data

    Changes in both MVPA and SED-time were independently associated with changes in VO2max, though the relationship was stronger for MVPA.

    “Changes in both MVPA and SED-time were independently associated with changes in VO 2max , though the relationship was stronger for the former”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    Upon univariate analysis, changes in MVPA and SED-time correlated significantly with changes in physical fitness parameters as well as in HbA1c, FPG, hs-CRP, total and fatal CHD 10-risk, BMI and waist circumference (for MVPA changes only), and total stroke 10-risk score (for SED-time changes only).

    “Upon univariate analysis, changes in MVPA and SED-time correlated significantly with those in physical fitness parameters as well as in HbA 1c , FPG, hs-CRP, total and fatal CHD 10-risk, BMI and waist circumference (for MVPA changes only), and total stroke 10-risk score (for SED-time changes only)”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Premiseown data

    In IDES_2, the increase versus control in MVPA was only 6.4 min/day during the 3-year period and 3.6 min/day at the end of the study.

    “However, while the increase versus control in MVPA was only 6.4 min Á day À1 during the 3-year period and 3.6 min Á day À1 at the end of the study”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [13] Balducci, 2019, Effect of a behavioral intervention strategy on sustained change in physical activity and sedentary behavior in patients with type 2 diabetes: the IDES_2 randomized clinical trial, JAMA source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    Both physical inactivity and sedentary behavior are independently associated with increased mortality from any cause and cardiovascular disease in the general population.

    “Both physical inactivity and sedentary behavior are independently associated with increased mortality from any cause and cardiovascular disease (CVD) in the general population (1,2)”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [1] Kraus, 2019, Physical activity, all-cause and cardiovascular mortality, and cardiovascular disease, Med Sci Sports Exerc source

      Not checked in the free run.

    • cites [2] Matthews, 2012, Amount of time spent in sedentary behaviors and cause-specific mortality in US adults, Am J Clin Nutr source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based). The quote only partly states this claim.

    Premiseown data

    In IDES_2, behavioral counseling promoted a sustained decrease in sedentary time of 0.8 h/day.

    “and decrease in sedentary time (SEDtime) (20.8 h Á day 21 )”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [13] Balducci, 2019, Effect of a behavioral intervention strategy on sustained change in physical activity and sedentary behavior in patients with type 2 diabetes: the IDES_2 randomized clinical trial, JAMA source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    Counseling interventions designed to promote walking through pedometers in the general population or in individuals with prediabetes or type 2 diabetes resulted in up to about 8 min/day increases in MVPA after 1 year and smaller (about 4 min/day), or even no, increments after longer follow-up, together with no change in SED-time.

    “Counseling interventions designed to promote walking through the provision of pedometers in the general population (8) or in individuals with prediabetes (9) or type 2 diabetes (10,11) resulted in up to $8 min Á day À1 increases in MVPA after 1 year and smaller ($4 min Á day À1 ), or even no, increments after longer follow-up, together with no change in SED-time.”
    Quote in the paperSubstantial claim0 of 4 sources checked
    • cites [8] Harris, 2018, Physical activity levels in adults and older adults 3-4 years after pedometer-based walking interventions: long-term follow-up of participants from two randomised controlled trials in UK primary care, PLoS Med source

      Not checked in the free run.

    • cites [9] Khunti, 2021, Promoting physical activity in a multi-ethnic population at high risk of diabetes: the 48-month PROPELS randomised controlled trial, BMC Med source

      Not checked in the free run.

    • cites [10] Andrews, 2011, Diet or diet plus physical activity versus usual care in patients with newly diagnosed type 2 diabetes: the Early ACTID randomised controlled trial, Lancet source

      Not checked in the free run.

    • cites [11] Unick, 2016, Four-year physical activity levels among intervention participants with type 2 diabetes, Med Sci Sports Exerc source

      Not checked in the free run.

  • May combine two claims.

    Interpretationown data

    This prespecified ancillary analysis of IDES_2 showed that both increases in MVPA and decreases in SED-time contributed to the associated improvements in physical fitness and CVD risk profile.

    “This prespecified ancillary analysis of the IDES_2 showed that both increases in MVPA and decreases in SED-time contributed to the associated improvements in physical fitness and CVD risk profile.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    Both physical inactivity and sedentary behavior are independently associated with increased mortality from any cause and cardiovascular disease in people with type 2 diabetes.

    “and also in people with type 2 diabetes (3,4)”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [3] Church, 2004, Exercise capacity and body composition as predictors of mortality among men with diabetes, Diabetes Care source

      Not checked in the free run.

    • cites [4] Loprinzi, 2016, The effects of objectively measured sedentary behavior on all-cause mortality in a national sample of adults with diabetes, Prev Med source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    People with type 2 diabetes are usually well below the recommended level of physical activity and spend many daily hours as sedentary time.

    “who are usually well below the recommended level of physical activity (PA) and spend many daily hours as sedentary time (SED-time) (5).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [5] Morrato, 2007, Physical activity in U.S. adults with diabetes and at risk for developing diabetes, 2003, Diabetes Care source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    In IDES_2, a counseling intervention targeting both PA and sedentary behavior resulted in clinically meaningful improvements in physical fitness and, to a lesser extent, in CVD risk factors and scores over a 3-year follow-up.

    “Conversely, in the Italian Diabetes and Exercise Study 2 (IDES_2), a counseling intervention targeting both PA and sedentary behavior, which was effective in promoting a sustained increase in PA and decrease in SED-time, resulted in clinically meaningful improvements in physical fitness and, to a lesser extent, in CVD risk factors and scores over a 3-year follow-up (13).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [13] Balducci, 2019, Effect of a behavioral intervention strategy on sustained change in physical activity and sedentary behavior in patients with type 2 diabetes: the IDES_2 randomized clinical trial, JAMA source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based).

    Premisecitation

    Waist circumference, triglycerides, and systolic BP were preferentially associated with MVPA.

    “while it is plausible that waist circumference, triglycerides, and systolic BP were preferentially associated with MVPA (28)”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [28] LaMonte, 2017, Both light intensity and moderate-to-vigorous physical activity measured by accelerometry are favorably associated with cardiometabolic risk factors in older women: the Objective Physical Activity and Cardiovascular Health (OPACH) Study, J Am Heart Assoc source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The benefits of PA on CVD events and all-cause and CVD mortality start with very modest amounts (approximately one-third the amount recommended by guidelines).

    “A pronouncement of the American College of Sports Medicine concluded that the benefits of PA on CVD events and all-cause and CVD mortality start with very modest amounts (approximately one-third the amount recommended by guidelines) (1).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [1] Kraus, 2019, Physical activity, all-cause and cardiovascular mortality, and cardiovascular disease, Med Sci Sports Exerc source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    In adults at high risk for type 2 diabetes and CVD, every 2,000 steps/day increment in ambulatory activity at baseline was associated with a 10% lower risk of CVD events, and each 2,000 steps/day change from baseline to 12 months was associated with an additional 8% difference.

    “Likewise, in adults at high risk for type 2 diabetes and CVD, every 2,000 step Á day À1 increment in ambulatory activity at baseline was associated with a 10% lower risk of CVD events and each 2,000 step Á day À1 change from baseline to 12 months was associated with an additional 8% difference (36).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [36] Yates, 2014, Association between change in daily ambulatory activity and cardiovascular events in people with impaired glucose tolerance (NAVIGATOR trial): a cohort analysis, Lancet source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    The study had a long duration and a large sample size.

    “the long study duration, and the large sample size.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    In inactive people, a 6 min/day difference in brisk walking (corresponding to ~500 steps in 5 min) was associated with significant health benefits (~4 life years gained).

    “This interpretation is consistent with a recent UK Biobank longitudinal study showing that, in inactive people, a 6 min Á day À1 difference in brisk walking (corresponding to $500 steps in 5 min [37]) was associated with significant health benefits ($4 life years gained) (38).”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [38] Chudasama, 2019, Physical activity, multimorbidity, and life expectancy: a UK Biobank longitudinal study, BMC Med source

      Not checked in the free run.

    • cites [37] Rowlands, 2021, Wrist-worn accelerometers: recommending ∼1.0 m g as the minimum clinically important difference (MCID) in daily average acceleration for inactive adults, Br J Sports Med source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S2 (checkable).

    Interpretationnone given

    The generalizability of the study's findings to different cohorts or settings requires further investigation and validation.

    “First, generalizability requires further investigation and validation in different cohorts or settings.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Premisecitation

    In walking-based intervention studies, MVPA ranged from ~25 to ~45 min/day at baseline and increased by up to ~8 min/day after 1 year and by one-half or less after longer follow-up.

    “Conversely, in walking-based intervention studies, percent increments were much smaller as MVPA ranged from $25 to $45 min Á day À1 at baseline and increased by up to $8 min Á day À1 after 1 year and by one-half or less after longer follow-up (8)(9)(10)(11).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites (8)(9)(10)(11)

      Not checked in the free run.

18 of 18
  • The authors state this as an assumption.

    The time patients were awake without wearing the accelerometer was spent in routine morning and evening sedentary activities, unless it was spent in activities that cannot be performed while wearing the accelerometer.

    “In this way, it was possible to assume that the time patients were awake without wearing the accelerometer was spent in routine morning and evening sedentary activities, unless it was spent in activities that cannot be performed while wearing the accelerometer (e.g., swimming).”
  • The authors state this as an assumption.

    SED-time was almost entirely reallocated to LPA.

    “As SEDtime was almost entirely reallocated to LPA, which contributed significantly to the increase in total PA volume, LPA was substituted for SED-time in model 2”
2 of 2

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • CHD risk-score changes disagree between stratifications

    Major

    Tables 2 and 3 stratify the same 267 completers, so their quartile results must yield the same overall mean change. The reported CHD risk-score values imply approximately −0.09% in Table 2 but +3.36% in Table 3, far beyond rounding.

  • Identical Table 2 results have different ANOVA P values

    Major

    The hs-CRP and CHD risk-score rows have identical means and SDs in every quartile and use the same quartile sizes, yet report P values of 0.654 and 0.002. Those identical inputs cannot produce different one-way ANOVA results.

  • Fatal stroke risk-score changes disagree between stratifications

    Major

    The fatal stroke risk-score quartile means imply an overall mean of about +3.16% in Table 2 and +0.41% in Table 3, although both tables cover the same 267 participants.

  • Quartile I MVPA mean differs from the table

    Minor

    The text describes the average MVPA change in quartile I as −10.8 min/day, but Tables 1 and 2 give its mean as −3.33 min/day. The stated −10.8 is approximately the lower endpoint of the quartile's range, not its mean.

  • Quartile II SED-time mean changes sign between tables

    Minor

    Table 1 gives the quartile II mean SED-time change as positive 0.09 h/day, while Table 3 gives it as negative 0.09 h/day.

5 of 5

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References 39 · Cited by 50

Authors
Balducci, S., Haxhi, J., Sacchetti, M., Orlando, G., Cardelli, P., Vitale, M., Mattia, L., Iacobini, C., Bollanti, L., Conti, F., Zanuso, S., Nicolucci, A., & Pugliese, G.
Affiliations
  • Azienda Ospedaliera Sant'Andrea (IT)
  • Foro Italico University of Rome (IT)
  • Manchester Metropolitan University (GB)
  • University of Greenwich (GB)
  • Mario Negri Sud Foundation (IT)
Corresponding author
Pugliese, Giuseppe
Venue
Diabetes Care
Published
2021-11-02
Volume
45
Issue
1
Pages
213-221
ISSN
0149-5992 (ISSN-L)
OpenAlex
W3209827762
Cited by
50
References
39
Citations by year
2026: 2 · 2025: 8 · 2024: 20 · 2023: 14 · 2022: 5
FWCI
6.16
Type
journal article
Language
en
Open access
Locations
  • Diabetes Care (publishedVersion)
  • PubMed (publishedVersion)
  • e-space (Manchester Metropolitan University) (acceptedVersion)
  • Figshare (submittedVersion)
  • IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
Funders
  • Eli Lilly and Company
  • AstraZeneca
  • Sanofi
  • Sigma-Tau Pharmaceuticals
  • Mylan
  • Novo Nordisk
Topics
  • Health Sciences › Medicine › Physiology › Physical Activity and Health
  • Health Sciences › Medicine › Complementary and alternative medicine › Cardiovascular and exercise physiology
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
Keywords
type 2 diabetes, physical activity, sedentary behavior, physical fitness, cardiometabolic risk, behavioral counseling, moderate-to-vigorous physical activity, light physical activity, cardiorespiratory fitness, HbA1c, accelerometer-measured activity, energy expenditure
MeSH terms
Cardiovascular Diseases, Diabetes Mellitus, Type 2, Humans, Physical Fitness, Exercise, Sedentary Behavior, Accelerometry

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