Samuel‐Hodge 2009.
| Methods |
Cluster randomised controlled trial: 24 churches randomly assigned, 201 participants involved Randomisation ratio: not specified. Assumed 1:1. 13 churches intervention, 11 churches control Superiority design |
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| Participants |
Inclusion criteria:
Exclusion criteria:
Diagnostic criteria: Participating population: African Americans diagnosed with type 2 diabetes who went to church |
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| Interventions |
Number of study centres: 24 churches involved in study Treatment before study: not stated Intervention: majority of intervention consisted of 12 biweekly group sessions, held at each church. Most sessions lasted between 90 and 120 minutes. Before each session, participants had their blood glucose checked and blood pressure checked and received feedback about their results. Each session opened with a prayer, followed by the main educational component of the session. Each session also involved a short physical activity segment (15 minutes, using chair exercises) and taste testing of 1 or 2 recipes. The format for sessions included small‐group activities designed to be acceptable to persons with very limited literacy skills and those unaccustomed to group education/interactions. Therefore sessions were interactive, included lots of visual and hands‐on activities, involved limited writing, used a game format for teaching nutrition concepts when feasible and included opportunities for participants to share their successes and struggles with efforts to change behaviours Before the 12 sessions, participants had a 60‐minute individual counselling session with a registered dietician to assess their usual dietary, physical activity and self‐management behaviours, to initiate counselling and to facilitate subsequent counselling. The church diabetes advisor phoned participants monthly to offer support for behaviour change to improve diabetes self‐management Finally, to try to co ordinate the intervention with participants' primary care physician, study staff sent 3 postcard messages of encouragement to participants on behalf of their primary care physician during the first 8 months of the study. Postcard messages were tailored to behavioural goals selected by participants and included brief messages relevant to dietary behaviour, physical activity and HbA1c Control: Control group received minimal intervention, which included mailing to participants of 2 pamphlets ("Healthy Eating" and "Staying Active"), published by the American Diabetes Association, and 3 bimonthly newsletters providing general information and study updates Provider: A registered dietician on the study staff led the first 7 group sessions with the assistance of a Church Diabetes Advisor (CDA). The CDA was a peer counsellor with type 2 diabetes, or who had lived with someone diagnosed with diabetes for at least 2 years. CDAs were selected on the basis of recommendations of the pastor and were trained over a 1‐month period (4 weekly 4‐hour sessions) in the areas of motivational interviewing techniques, listening skills, diabetes self‐management and telephone counselling. The educational components of sessions 8 to 11 were led by a health professional from the local community who was identified and invited to participate by the CDA. For the last session, participants were given the option to choose a health‐related presentation or to have a potluck meal. The individual counselling session at the start was led by a registered dietician |
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| Outcomes | Assessed at baseline, 8 months and 12 months Primary outcome: comparison of A1C levels at 8 months All outcomes:
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| Study details |
Run‐in period: not stated Study terminated before regular end: no |
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| Publication details |
Language of publication: English Funding: Centers for Disease Control and Prevention Publication status: peer‐reviewed journal |
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| Stated aim of study | This was a prospective, group‐randomised, multi‐site trial conducted to test a culturally appropriate, church‐based intervention to improve diabetes self‐management | |
| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "determined by random numbers generated by a statistical consultant using a personal computer" |
| Allocation concealment (selection bias) | Low risk | Comment: Allocation of this predetermined random number sequence was concealed by using "a set of sequentially numbered sealed envelopes" |
| Blinding of participants and personnel (performance bias) Objective outcomes | High risk | Comment: participants not blinded |
| Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Comment: participants not blinded, and fact that provider (church diabetes advisor) is a member of that specific church may lead to exposure of participants to more intervention than specified (e.g. meeting the provider at church between sessions) |
| Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C | Low risk | Comment: not blinded but unlikely to affect outcome; detailed description of how BP measured and number of times, etc |
| Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Quote from publication: "Except for the final telephone interview assessing the acceptability of the intervention, personnel conducting follow‐up interviews were masked to the participants study group" Comment: Self‐reported subjective outcome measures were used, which are at high risk of bias given that participants were not blinded |
| Incomplete outcome data (attrition bias) Objective outcomes | Low risk | Comment: low number lost to follow‐up for similar reasons. ITT analysis |
| Incomplete outcome data (attrition bias) Subjective outcomes | Low risk | Comment: low number lost to follow‐up for similar reasons. ITT analysis |
| Selective reporting (reporting bias) | Unclear risk | Comment: data extensively presented but study protocol not seen |
| Other bias | Unclear risk | Comment: none |