Parikh 2010.
| Methods |
Study design: randomized controlled trial Sampling frame: community members with pre‐diabetes referred from primary care clinicians and recruited at community organizations Sampling method: participants randomly assigned to intervention or delayed intervention (control) arm via blocked randomization (n = 178) Collection method: biometric data, questionnaires, self report of behavior change Description of the community coalition: Community Action Board, composed of 20 leaders, activists, and residents of East Harlem |
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| Participants |
Communities: East Harlem, NY Country: USA Ages included in assessment: > 18 Reasons provided for selection of intervention community: East Harlem comprises the poorest and most obese population in Manhattan; this population has the highest prevalence of diabetes and mortality rates in the city Intervention community (population size): not reported Comparison community (population size): same |
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| Interventions |
Name of intervention: Project HEED (Help Educate to Eliminate Diabetes) Theory: Self Efficacy Theory Aim: to measure the effectiveness of a peer‐led lifestyle intervention in promoting weight loss among overweight adults with pre‐diabetes in East Harlem Description of costs and resources: not reported. Components of the intervention: peer‐led intervention to promote weight loss and prevent diabetes; social marketing Start date: July 2007 Duration: February 2008 |
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| Outcomes |
Outcomes and measures: weight, blood pressure, health behaviors Time points: baseline (intervention n = 50, control n = 49), 3, 6, 12 months (12‐month intervention: n = 35; control: n = 37) |
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| Notes |
Funder: National Center on Minority Health and Health Disparities and the New York State Department of Health Funding source: government |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants randomly assigned using blocked randomization |
| Allocation concealment (selection bias) | High risk | No allocation concealment |
| Baseline outcome measurement similar | Low risk | No statistically significant differences between groups for anthropometric measures or behaviors |
| Baseline characteristics similar | Low risk | No statistically significant differences between groups for demographic characteristics |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding reported |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Attrition: 23 of 83 participants lost to follow‐up at 12 months; employed last‐observation‐carried‐forward strategy to impute missing weights at follow‐up |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding reported |
| Protection against contamination | High risk | Likelihood of contamination high; participants in intervention and control groups live in same community |
| Selective reporting (reporting bias) | Low risk | Primary outcome of weight loss was reported |
| Other bias | Unclear risk | Not powered to detect changes in diet or physical activity as measured by questionnaire&& |