Shapses 2001.
Study characteristics | ||
Methods | Randomised, controlled, parallel‐group trial (2 groups) Duration of study: not specified Duration of follow‐up: 6 months |
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Participants |
Setting characteristic: participants were in a moderate weight‐loss programme Inclusion criteria: obese healthy women; stable weight for ≥ 3 months before the start of the study Exclusion: pregnant or lactating within the previous year; history of an irregular menstrual cycle; ill or taking medication known to interfere with bone metabolism, including oral contraceptives Age: 42.1 (SD 6.2) years Sample: Total included 60
Country: USA |
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Interventions |
Intervention group:
Control group:
Other intervention: reduced calorie diet was then individually created using the American Diabetic Association Exchange List. Administration: daily Duration of treatment: 6 months |
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Outcomes | BMD: lumbar and total body BMC: lumbar and total body Biomarkers: pyridinoline, deoxypyridinoline, N‐telopeptide, osteocalcin, parathyroid hormone, and 25‐hydroxyvitamin D Intake: energy, protein, fat, carbohydrates, calcium, phosphorus, vitamin D, and magnesium. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not specified. |
Allocation concealment (selection bias) | Unclear risk | Not specified. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not specified. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not specified. |
Incomplete outcome data (attrition bias) All outcomes | High risk | The analysis of the placebo group showed substantial deviations from the randomised intervention. |
Selective reporting (reporting bias) | High risk | The groups assigned initially from the methodology, during the study were arbitrarily reassigned. |
Other bias | Unclear risk | The final allocation did not coincide with the baseline allocation of participants. |