Sheppard 2016.
| Methods |
Design: 2‐arm randomised controlled trial Country: USA Accrual dates: December 2010 to January 2012 Trial Reg: NR |
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| Participants |
Number randomised: 31 106 screened, 37 ineligible, 69 eligible, 50 consent, 19 declined participation, 19 not randomised, 15 intervention, 16 control, 12 completed, 1 withdrew, 3 lost to follow‐up, 10 completed, 5 withdrew Inclusion: self‐identified as African American. Overweight or obese (BMI ≥ 25 kg/m² and ≤ 40 kg/m². Sedentary (exercises less than 60 min/week for previous 6 months). Early‐stage/localised breast cancer 6 months. 5 years post active treatment. Ability to read and speak English. Ability to provide informed consent Exclusion: history of other cancers (except basal or squamous cell carcinoma). Recurrence of breast cancer. Current enrolment in another physical activity or dietary clinical trial or commercial programmes like Weight Watchers. Inability to commit to the intervention schedule. Telephone inaccessibility. Pre‐existing conditions that preclude adherence to an unsupervised exercise programme. Failure to provide medical clearance. Morbidly obese (BMI ≥ 40 kg/m²) Gender: female Age: mean 54.7 (SD 9.8) years Type of cancer: breast Therapy previously received for cancer: NR Cancer staging: early stage/localised Ethnicity: African American Baseline physical activity: Control (minutes/week (mean ± SD)): vigorous 37.5 ± 71.4, moderate 53.6 ± 60.9, walking 100.0 ± 87.6, total 205.0 ± 196.9 Metabolic equivalents (MET) (minutes/week (mean ± SD)): vigorous 300 ± 570.9, moderate 214.5 ± 243.5, walking 313.5 ± 283.9, total 688.5 ± 794.2 Intervention: (minutes/week (mean ± SD)): vigorous 37.5 ± 84.5, moderate 62.5 ± 129.8, walking 140.7 ± 229.0, total 291.7 ± 387.0 Metabolic equivalents (MET) (minutes/week (mean ± SD)): vigorous 300 ± 675.8, moderate 250.0 ± 519.2, walking 464.4 ± 755.7, total 291.7 ± 387.0 Education: NR |
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| Interventions |
Comparison: Stepping STONE intervention (physical activity and diet intervention) vs control (general health info for cancer survivors) Intervention: 12‐week Stepping STONE intervention based on theory of planned behaviour and social‐cognitive theory. Participants met once every 2 weeks for 90‐minute group session – 30 minutes physical activity and 60 minutes educational session. On weeks not meeting, individual telephone coaching sessions with a trained survivor coach for 15 minutes Control: general health information for cancer survivors – facing forward life after cancer treatment. Offered intervention at completion of the study |
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| Outcomes |
Weight, waist, and hip circumference: physical measurement Food intake: participants recorded food intake for 4 days Duration of follow‐up: 12 weeks |
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| Notes | Funding: National Cancer Institute R21CA149996, Biostatistics and Bioinformatics Shared Resource and Tissue Culture Shared Resource NCI grant P30CA51008 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information about the sequence generation process to permit judgement |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | No blinding; outcome is not likely to be influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Subjective outcomes | Unclear risk | Not reported. No subjective outcomes appropriate for this review |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | No blinding; outcome is not likely to be influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Not reported. No subjective outcomes appropriate for this review |
| Incomplete outcome data (attrition bias) Objective | High risk | Overall attrition rate is high (29%) and is likely to have clinical relevance |
| Incomplete outcome data (attrition bias) Subjective | Unclear risk | Not reported. No subjective outcomes appropriate for this review |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement |
| Other bias | Unclear risk | Insufficient information to permit judgement |