Abstract
OBJECTIVES: To test the long-term effectiveness of a total diet replacement programme (TDR) for routine treatment of obesity in aprimary care setting.
METHODS: This study was a pragmatic, two-arm, parallel-group, open-label, individually randomised controlled trial in adults withobesity. The outcomes were change in weight and biomarkers of diabetes and cardiovascular disease risk from baseline to 3 years,analysed as intention-to-treat with mixed effects models.
INTERVENTIONS: The intervention was TDR for 8 weeks, followed by food-reintroduction over 4 weeks. Behavioural support wasprovided weekly for 8 weeks, bi-weekly for the next 4 weeks, then monthly for 3 months after which no further support wasprovided. The usual care (UC) group received dietary advice and behavioural support from a practice nurse for up to 3 months.
RESULTS: Outcome measures were collected from 179 (66%) participants. Compared with baseline, at 3 years the TDR group lost−6.2 kg (SD 9.1) and usual care −2.7 kg (SD 7.7); adjusted mean difference −3.3 kg (95% CI: −5.2, −1.5), p < 0.0001. Regain fromprogramme end (6 months) to 3 years was greater in TDR group +8.9 kg (SD 9.4) than UC + 1.2, (SD 9.1); adjusted mean difference+6.9 kg (95% CI 4.2, 9.5) P < 0.001. At 3 years TDR led to greater reductions than UC in diastolic blood pressure (mean difference−3.3 mmHg (95% CI:−6.2; −0.4) P = 0.024), and systolic blood pressure (mean differences −3.7 mmHg (95% CI: −7.4; 0.1) P =0.057). There was no evidence of differences between groups in the change from baseline to 3 years HbA1c (−1.9 mmol/mol (95%CI: −0.7; 4.5; P = 0.15), LDL cholesterol concentrations (0.2 mmol/L (95% CI −0.3, 0.7) P = 0.39), cardiovascular risk score (QRISK2)(−0.37 (95% CI −0.96; 0.22); P = 0.22).
CONCLUSIONS: Treatment of people with obesity with a TDR programme compared with support from a practice nurse leads togreater weight loss which persists to at least 3 years, but there was only evidence of sustained improvements in BP and not in otheraspects of cardiometabolic risk.
METHODS: This study was a pragmatic, two-arm, parallel-group, open-label, individually randomised controlled trial in adults withobesity. The outcomes were change in weight and biomarkers of diabetes and cardiovascular disease risk from baseline to 3 years,analysed as intention-to-treat with mixed effects models.
INTERVENTIONS: The intervention was TDR for 8 weeks, followed by food-reintroduction over 4 weeks. Behavioural support wasprovided weekly for 8 weeks, bi-weekly for the next 4 weeks, then monthly for 3 months after which no further support wasprovided. The usual care (UC) group received dietary advice and behavioural support from a practice nurse for up to 3 months.
RESULTS: Outcome measures were collected from 179 (66%) participants. Compared with baseline, at 3 years the TDR group lost−6.2 kg (SD 9.1) and usual care −2.7 kg (SD 7.7); adjusted mean difference −3.3 kg (95% CI: −5.2, −1.5), p < 0.0001. Regain fromprogramme end (6 months) to 3 years was greater in TDR group +8.9 kg (SD 9.4) than UC + 1.2, (SD 9.1); adjusted mean difference+6.9 kg (95% CI 4.2, 9.5) P < 0.001. At 3 years TDR led to greater reductions than UC in diastolic blood pressure (mean difference−3.3 mmHg (95% CI:−6.2; −0.4) P = 0.024), and systolic blood pressure (mean differences −3.7 mmHg (95% CI: −7.4; 0.1) P =0.057). There was no evidence of differences between groups in the change from baseline to 3 years HbA1c (−1.9 mmol/mol (95%CI: −0.7; 4.5; P = 0.15), LDL cholesterol concentrations (0.2 mmol/L (95% CI −0.3, 0.7) P = 0.39), cardiovascular risk score (QRISK2)(−0.37 (95% CI −0.96; 0.22); P = 0.22).
CONCLUSIONS: Treatment of people with obesity with a TDR programme compared with support from a practice nurse leads togreater weight loss which persists to at least 3 years, but there was only evidence of sustained improvements in BP and not in otheraspects of cardiometabolic risk.
Original language | English |
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Pages (from-to) | 2432–2438 |
Number of pages | 7 |
Journal | International Journal of Obesity |
Volume | 45 |
Early online date | 23 Jul 2021 |
DOIs | |
Publication status | Published - Nov 2021 |
Bibliographical note
Funding:This study was funded by National Institute of Health Research Applied Research Collaboration at Oxford Health NHS Foundation Trust. SAJ, PA, and NA are also supported by the Oxford NIHR Biomedical Research Centre and SAJ and PA are NIHR senior investigators. The study was conducted and analysed in collaboration with the Oxford Primary Care and Vaccines clinical trials unit. The funders had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The views are those expressed by the authors and not necessarily those of the NHS, NIHR, or Department of Health. The University of Oxford holds the relevant clinical trials insurance policy for this study and acted as the study sponsor.