Diet or diet plus physical activity versus usual care in patients with newly diagnosed type 2 diabetes: the Early ACTID randomised controlled trial
Open accessAbstract
Background Lifestyle changes soon after diagnosis might improve outcomes in patients with type 2 diabetes mellitus, but no large trials have compared interventions. We investigated the effects of diet and physical activity on blood pressure and glucose concentrations.Methods We did a randomised, controlled trial in southwest England in adults aged 30-80 years in whom type 2 diabetes had been diagnosed 5-8 months previously. Participants were assigned usual care (initial dietary consultation and follow-up every 6 months; control group), an intensive diet intervention (dietary consultation every 3 months with monthly nurse support), or the latter plus a pedometer-based activity programme, in a 2:5:5 ratio. The primary endpoint was improvement in glycated haemoglobin A(1c)(HbA(1c)) concentration and blood pressure at 6 months. Analysis was done by intention to treat. This study is registered, number ISRCTN92162869.Findings Of 593 eligible individuals, 99 were assigned usual care, 248 the diet regimen, and 246 diet plus activity. Outcome data were available for 587 (99%) and 579 (98%) participants at 6 and 12 months, respectively. At 6 months, glycaemic control had worsened in the control group (mean baseline HbA(1c) percentage 6·72, SD 1·02, and at 6 months 6·86, 1·02) but improved in the diet group (baseline-adjusted difference in percentage of HbA(1c) -0·28%, 95% CI -0·46 to -0·10; p=0·005) and diet plus activity group (-0·33%, -0·51 to -0·14; p<0·001). These differences persisted to 12 months, despite less use of diabetes drugs. Improvements were also seen in bodyweight and insulin resistance between the intervention and control groups. Blood pressure was similar in all groups.Interpretation An intensive diet intervention soon after diagnosis can improve glycaemic control. The addition of an activity intervention conferred no additional benefit.Funding Diabetes UK and the UK Department of Health.
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The recruitment rate compares well with the Early-ACTID trial, where 98% of eligible patients with newly diagnosed T2D were randomised.
“This recruitment rate compares well with the Diet or diet plus physical activity versus usual care in patients with newly diagnosed type 2 diabetes trial (Early-ACTID), where 98% of eligible patients with newly diagnosed T2D (5- to 8 months since diagnosis) were randomised to receive usual care or lifestyle advice.14”
From Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes (MOTIVATE-T2D): a decentralised feasibility randomised controlled trial delivered across the UK and Canada (2025) · cites this paper as [14]
The Patients section reports that participants had been diagnosed within the previous 5–8 months and were randomised to usual care, intensive diet, or intensive diet plus activity. But the Results section says 712 were eligible for face-to-face screening and 593 were enrolled—about 83%, not 98%. The cited copy does not substantiate the stated 98% recruitment rate. (LLM, conf=0.88)
Experimental — accuracy not yet measuredCompared with Early-ACTID, the current trial recruited a more ethnically diverse population.
“Compared with Early-ACTID, which also recruited people with newly diagnosed T2D in the UK, the current trial recruited a more ethnically diverse population.14”
From Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes (MOTIVATE-T2D): a decentralised feasibility randomised controlled trial delivered across the UK and Canada (2025) · cites this paper as [14]
The Patients section (page unavailable) confirms that Early ACTID recruited people recently diagnosed with type 2 diabetes in southwest England. Our copy does not report the participants’ ethnicity, so it cannot establish that the current trial recruited a more ethnically diverse population (searched: ethnic, white, and baseline ethnicity). (LLM, conf=0.79)
Experimental — accuracy not yet measuredUse of physical activity trackers has been associated with increased physical activity in people with T2D, which can be maintained for up to 12 months.
“Use of PA trackers has been associated with increased PA in people with T2D,13 which can be maintained for up to 12 months.14”
The centralised Early-ACTID trial collected primary outcome data (HbA1c) from 98% of participants at 12 months.
“the centralised Early-ACTID trial collected primary outcome data (HbA1c) from 98% of participants at 12 months.”
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.”
In these walking intervention studies, the intervention failed to significantly improve CVD risk factors and other surrogate outcomes.
“However, in these studies, the intervention failed to significantly improve CVD risk factors and other surrogate outcomes (8)(9)(10)”
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- Authors
- Andrews, R., Cooper, A., Montgomery, A., Norcross, A., Peters, T., Sharp, D., Jackson, N., Fitzsimons, K., Bright, J., Coulman, K., England, C., Gorton, J., McLenaghan, A., Paxton, E., Polet, A., Thompson, C., & Dayan, C.
- Affiliations
- University of Bristol (GB)
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2011-07
- Volume
- 378
- Issue
- 9786
- Pages
- 129-139
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2121744979
- Cited by
- 302
- References
- 42
- Citations by year
- 2026: 7 · 2025: 11 · 2024: 14 · 2023: 16 · 2022: 12 · 2021: 26 · 2020: 6 · 2019: 22 · 2018: 18 · 2017: 32 · 2016: 22 · 2015: 27 · 2014: 32 · 2013: 30 · 2012: 17
- FWCI
- 22.80
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- Bristol Research (University of Bristol) (publishedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion, other-oa)
- Funders
- National Institute for Health and Care Research
- Diabetes UK
- Economic and Social Research Council (ES/G007543/1)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Keywords
- type 2 diabetes, newly diagnosed diabetes, dietary intervention, physical activity, glycemic control, HbA1c, blood pressure, nursing support, body weight, insulin resistance, lifestyle intervention
- MeSH terms
- Adult, Aged, Aged, 80 and over, Combined Modality Therapy, Diabetes Mellitus, Type 2, Exercise Therapy, Female, Humans, Life Style, Male, Middle Aged, Weight Loss, Health Behavior, Intention to Treat Analysis
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