Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Mar;40(3):e15010.
doi: 10.1111/dme.15010. Epub 2022 Nov 29.

Physical activity, inactivity and sleep during the Diabetes Remission Clinical Trial (DiRECT)

Affiliations
Randomized Controlled Trial

Physical activity, inactivity and sleep during the Diabetes Remission Clinical Trial (DiRECT)

Sophie Cassidy et al. Diabet Med. 2023 Mar.

Abstract

Aims: As sustained weight loss is vital for achieving remission of type 2 diabetes, we explored whether randomisation to weight loss plus maintenance in the DiRECT trial was associated with physical activity, inactivity or sleep.

Methods: Participants were randomised to either a dietary weight management programme or best-practice care. The weight management group were encouraged to increase daily physical activity to their sustainable maximum. Objective measurement was achieved using a wrist-worn GENEActiv accelerometer for 7 days at baseline, 12 and 24 months in both groups.

Results: Despite average weight loss of 10 kg at 12 months in the intervention (n = 66) group, there were no differences in total physical activity or inactivity compared with the control (n = 104) at any time point. However, in our exploratory analysis, those who lost more than 10% of their baseline body weight performed on average 11 mins/day more light activity than the <10% group at 24 months (p = 0.033) and had significantly lower bouts of Inactivity30min (interaction, p = 0.005) across 12 and 24 months. At 24 months, the ≥10% group had higher daily acceleration (38.5 ± 12.1 vs. 33.2 ± 11.1 mg, p = 0.020), and higher accelerations in the most active 5-hour period (59.4 ± 21.8 vs. 50.6 ± 18.3 mg, p = 0.023). Wakefulness after sleep onset decreased in the intervention group compared with the control group and also in the ≥10% weight loss group at 12 and 24 months.

Conclusions: Randomisation to a successful intensive weight loss intervention, including regular physical activity encouragement, was not associated with increased physical activity although sleep parameters improved. Physical activity was greater, and night-time waking reduced in those who maintained >10% weight loss at 12 and 24 months. TRIAL REGISTRATION ISRCTN03267836.

Keywords: diabetes remission; lifestyle intervention; physical activity; sleep; weight loss maintenance.

PubMed Disclaimer

Conflict of interest statement

AB reports honoraria from Novo Nordisk and Eli Lilly and programme content creator for Discover Momenta Diabetes Remission Programme outside the submitted work. NB was previously employed by Counterweight Ltd and reports personal fees for freelance work and shareholdings from Counterweight Ltd during the conduct of the study and funding of PhD fees and conference attendance from Cambridge Weight Plan outside the submitted work. GT reports funding for PhD fees, conference attendance and departmental research support from Cambridge Weight Plan outside the submitted work. LM reports employment by Counterweight during the conduct of study and reports consultancy fees from Cambridge Weight Plan and Counterweight Ltd outside the submitted work. WSL reports support for conference attendance from Cambridge Weight Plan, outside the submitted work. MEJL reports support for meeting attendance and departmental research support from Cambridge Weight Plan outside the submitted work, lecturing fees from Nestle and Oviva, and has provided unpaid consultancy to Counterweight Ltd. RT reports grants from Diabetes UK to conduct DiRECT, lecture fees from Novartis, Janssen, Nestle Healthcare and Lilly, authorship of book ‘Life without Diabetes’ and consultancy fees from Wilmington Healthcare outside the submitted work. All other authors declare no competing interests.

Figures

FIGURE 1
FIGURE 1
Change in A‐light activity, B‐M5, C‐ Inactivity30min and D‐average acceleration in <10% group (blue bars) and ≥10% group (orange bars) at 12 and 24 months from baseline. ‡Change between baseline and 24 months is significantly different between <10% and ≥ 10% groups, p < 0.05. Error bars show standard error.

References

    1. Lean ME, Leslie WS, Barnes AC, et al. Primary care‐led weight management for remission of type 2 diabetes (DiRECT): an open‐label, cluster‐randomised trial. Lancet. 2018;391(10120):P541‐P551. - PubMed
    1. Lean MEJ, Leslie WS, Barnes AC, et al. Durability of a primary care‐led weight‐management intervention for remission of type 2 diabetes: 2‐year results of the DiRECT open‐label, cluster‐randomised trial. Lancet Diabetes Endocrinol. 2019;8587(19):1‐12. - PubMed
    1. Colberg SR, Sigal RJ, Yardley JE, et al. Physical activity/exercise and diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2016;39(11):2065‐2079. - PMC - PubMed
    1. Gregg EW, Chen H, Wagenknecht LE, et al. Association of an intensive lifestyle intervention with remission of type 2 diabetes. Jama ‐ J Am Med Assoc. 2012;308(23):2489‐2496. - PMC - PubMed
    1. Dombrowski SU, Knittle K, Avenell A, Araújo‐Soares V, Sniehotta FF. Long term maintenance of weight loss with non‐surgical interventions in obese adults: systematic review and meta‐analyses of randomised controlled trials. BMJ. 2014;14(348):g2646. - PMC - PubMed

Publication types