Head-to-head comparison of intensive lifestyle intervention (U-TURN) versus conventional multifactorial care in patients with type 2 diabetes: protocol and rationale for an assessor-blinded, parallel group and randomised trial

Research output: Contribution to journalJournal articleResearchpeer-review

Standard

Head-to-head comparison of intensive lifestyle intervention (U-TURN) versus conventional multifactorial care in patients with type 2 diabetes : protocol and rationale for an assessor-blinded, parallel group and randomised trial. / Ried-Larsen, Mathias; Christensen, Robin; Hansen, Katrine B; Johansen, Mette Y; Pedersen, Maria; Zacho, Morten; Hansen, Louise S; Kofoed, Katja; Thomsen, Katja; Jensen, Mette S; Nielsen, Rasmus O; MacDonald, Chris; Langberg, Henning; Vaag, Allan A; Pedersen, Bente K; Karstoft, Kristian.

In: B M J Open, Vol. 5, No. 12, e009764, 19.12.2015, p. 1-18.

Research output: Contribution to journalJournal articleResearchpeer-review

Harvard

Ried-Larsen, M, Christensen, R, Hansen, KB, Johansen, MY, Pedersen, M, Zacho, M, Hansen, LS, Kofoed, K, Thomsen, K, Jensen, MS, Nielsen, RO, MacDonald, C, Langberg, H, Vaag, AA, Pedersen, BK & Karstoft, K 2015, 'Head-to-head comparison of intensive lifestyle intervention (U-TURN) versus conventional multifactorial care in patients with type 2 diabetes: protocol and rationale for an assessor-blinded, parallel group and randomised trial', B M J Open, vol. 5, no. 12, e009764, pp. 1-18. https://doi.org/10.1136/bmjopen-2015-009764

APA

Ried-Larsen, M., Christensen, R., Hansen, K. B., Johansen, M. Y., Pedersen, M., Zacho, M., ... Karstoft, K. (2015). Head-to-head comparison of intensive lifestyle intervention (U-TURN) versus conventional multifactorial care in patients with type 2 diabetes: protocol and rationale for an assessor-blinded, parallel group and randomised trial. B M J Open, 5(12), 1-18. [e009764]. https://doi.org/10.1136/bmjopen-2015-009764

Vancouver

Ried-Larsen M, Christensen R, Hansen KB, Johansen MY, Pedersen M, Zacho M et al. Head-to-head comparison of intensive lifestyle intervention (U-TURN) versus conventional multifactorial care in patients with type 2 diabetes: protocol and rationale for an assessor-blinded, parallel group and randomised trial. B M J Open. 2015 Dec 19;5(12):1-18. e009764. https://doi.org/10.1136/bmjopen-2015-009764

Author

Ried-Larsen, Mathias ; Christensen, Robin ; Hansen, Katrine B ; Johansen, Mette Y ; Pedersen, Maria ; Zacho, Morten ; Hansen, Louise S ; Kofoed, Katja ; Thomsen, Katja ; Jensen, Mette S ; Nielsen, Rasmus O ; MacDonald, Chris ; Langberg, Henning ; Vaag, Allan A ; Pedersen, Bente K ; Karstoft, Kristian. / Head-to-head comparison of intensive lifestyle intervention (U-TURN) versus conventional multifactorial care in patients with type 2 diabetes : protocol and rationale for an assessor-blinded, parallel group and randomised trial. In: B M J Open. 2015 ; Vol. 5, No. 12. pp. 1-18.

Bibtex

@article{36dcb68477cb4f6faddbf39dba78e415,
title = "Head-to-head comparison of intensive lifestyle intervention (U-TURN) versus conventional multifactorial care in patients with type 2 diabetes: protocol and rationale for an assessor-blinded, parallel group and randomised trial",
abstract = "INTRODUCTION: Current pharmacological therapies in patients with type 2 diabetes (T2D) are challenged by lack of sustainability and borderline firm evidence of real long-term health benefits. Accordingly, lifestyle intervention remains the corner stone in the management of T2D. However, there is a lack of knowledge regarding the optimal intervention programmes in T2D ensuring both compliance as well as long-term health outcomes. Our objective is to assess the effects of an intensive lifestyle intervention (the U-TURN intervention) on glycaemic control in patients with T2D. Our hypothesis is that intensive lifestyle changes are equally effective as standard diabetes care, including pharmacological treatment in maintaining glycaemic control (ie, glycated haemoglobin (HbA1c)) in patients with T2D. Furthermore, we expect that intensive lifestyle changes will decrease the need for antidiabetic medications.METHODS AND ANALYSIS: The study is an assessor-blinded, parallel group and a 1-year randomised trial. The primary outcome is change in glycaemic control (HbA1c), with the key secondary outcome being reductions in antidiabetic medication. Participants will be patients with T2D (T2D duration <10 years) without complications who are randomised into an intensive lifestyle intervention (U-TURN) or a standard care intervention in a 2:1 fashion. Both groups will be exposed to the same standardised, blinded, target-driven pharmacological treatment and can thus maintain, increase, reduce or discontinue the pharmacological treatment. The decision is based on the standardised algorithm. The U-TURN intervention consists of increased training and basal physical activity level, and an antidiabetic diet including an intended weight loss. The standard care group as well as the U-TURN group is offered individual diabetes management counselling on top of the pharmacological treatment.ETHICS AND DISSEMINATION: This study has been approved by the Scientific Ethical Committee at the Capital Region of Denmark (H-1-2014-114). Positive, negative or inconclusive findings will be disseminated in peer-reviewed journals, at national and international conferences.TRIAL REGISTRATION NUMBER: NCT02417012.",
author = "Mathias Ried-Larsen and Robin Christensen and Hansen, {Katrine B} and Johansen, {Mette Y} and Maria Pedersen and Morten Zacho and Hansen, {Louise S} and Katja Kofoed and Katja Thomsen and Jensen, {Mette S} and Nielsen, {Rasmus O} and Chris MacDonald and Henning Langberg and Vaag, {Allan A} and Pedersen, {Bente K} and Kristian Karstoft",
note = "Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/",
year = "2015",
month = "12",
day = "19",
doi = "10.1136/bmjopen-2015-009764",
language = "English",
volume = "5",
pages = "1--18",
journal = "B M J Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "12",

}

RIS

TY - JOUR

T1 - Head-to-head comparison of intensive lifestyle intervention (U-TURN) versus conventional multifactorial care in patients with type 2 diabetes

T2 - protocol and rationale for an assessor-blinded, parallel group and randomised trial

AU - Ried-Larsen, Mathias

AU - Christensen, Robin

AU - Hansen, Katrine B

AU - Johansen, Mette Y

AU - Pedersen, Maria

AU - Zacho, Morten

AU - Hansen, Louise S

AU - Kofoed, Katja

AU - Thomsen, Katja

AU - Jensen, Mette S

AU - Nielsen, Rasmus O

AU - MacDonald, Chris

AU - Langberg, Henning

AU - Vaag, Allan A

AU - Pedersen, Bente K

AU - Karstoft, Kristian

N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

PY - 2015/12/19

Y1 - 2015/12/19

N2 - INTRODUCTION: Current pharmacological therapies in patients with type 2 diabetes (T2D) are challenged by lack of sustainability and borderline firm evidence of real long-term health benefits. Accordingly, lifestyle intervention remains the corner stone in the management of T2D. However, there is a lack of knowledge regarding the optimal intervention programmes in T2D ensuring both compliance as well as long-term health outcomes. Our objective is to assess the effects of an intensive lifestyle intervention (the U-TURN intervention) on glycaemic control in patients with T2D. Our hypothesis is that intensive lifestyle changes are equally effective as standard diabetes care, including pharmacological treatment in maintaining glycaemic control (ie, glycated haemoglobin (HbA1c)) in patients with T2D. Furthermore, we expect that intensive lifestyle changes will decrease the need for antidiabetic medications.METHODS AND ANALYSIS: The study is an assessor-blinded, parallel group and a 1-year randomised trial. The primary outcome is change in glycaemic control (HbA1c), with the key secondary outcome being reductions in antidiabetic medication. Participants will be patients with T2D (T2D duration <10 years) without complications who are randomised into an intensive lifestyle intervention (U-TURN) or a standard care intervention in a 2:1 fashion. Both groups will be exposed to the same standardised, blinded, target-driven pharmacological treatment and can thus maintain, increase, reduce or discontinue the pharmacological treatment. The decision is based on the standardised algorithm. The U-TURN intervention consists of increased training and basal physical activity level, and an antidiabetic diet including an intended weight loss. The standard care group as well as the U-TURN group is offered individual diabetes management counselling on top of the pharmacological treatment.ETHICS AND DISSEMINATION: This study has been approved by the Scientific Ethical Committee at the Capital Region of Denmark (H-1-2014-114). Positive, negative or inconclusive findings will be disseminated in peer-reviewed journals, at national and international conferences.TRIAL REGISTRATION NUMBER: NCT02417012.

AB - INTRODUCTION: Current pharmacological therapies in patients with type 2 diabetes (T2D) are challenged by lack of sustainability and borderline firm evidence of real long-term health benefits. Accordingly, lifestyle intervention remains the corner stone in the management of T2D. However, there is a lack of knowledge regarding the optimal intervention programmes in T2D ensuring both compliance as well as long-term health outcomes. Our objective is to assess the effects of an intensive lifestyle intervention (the U-TURN intervention) on glycaemic control in patients with T2D. Our hypothesis is that intensive lifestyle changes are equally effective as standard diabetes care, including pharmacological treatment in maintaining glycaemic control (ie, glycated haemoglobin (HbA1c)) in patients with T2D. Furthermore, we expect that intensive lifestyle changes will decrease the need for antidiabetic medications.METHODS AND ANALYSIS: The study is an assessor-blinded, parallel group and a 1-year randomised trial. The primary outcome is change in glycaemic control (HbA1c), with the key secondary outcome being reductions in antidiabetic medication. Participants will be patients with T2D (T2D duration <10 years) without complications who are randomised into an intensive lifestyle intervention (U-TURN) or a standard care intervention in a 2:1 fashion. Both groups will be exposed to the same standardised, blinded, target-driven pharmacological treatment and can thus maintain, increase, reduce or discontinue the pharmacological treatment. The decision is based on the standardised algorithm. The U-TURN intervention consists of increased training and basal physical activity level, and an antidiabetic diet including an intended weight loss. The standard care group as well as the U-TURN group is offered individual diabetes management counselling on top of the pharmacological treatment.ETHICS AND DISSEMINATION: This study has been approved by the Scientific Ethical Committee at the Capital Region of Denmark (H-1-2014-114). Positive, negative or inconclusive findings will be disseminated in peer-reviewed journals, at national and international conferences.TRIAL REGISTRATION NUMBER: NCT02417012.

U2 - 10.1136/bmjopen-2015-009764

DO - 10.1136/bmjopen-2015-009764

M3 - Journal article

VL - 5

SP - 1

EP - 18

JO - B M J Open

JF - B M J Open

SN - 2044-6055

IS - 12

M1 - e009764

ER -

ID: 159232150