Anand 2007.
Methods |
Design: RCT Timing: Prospective Allocation to group: Random Number of clusters or sites: 51 households Number of individuals: 159 Length of intervention: 6 months |
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Participants |
General description of participants: 2‐parent families with at least 1 child living in an Aboriginal reserve in Ontario, Canada Age: All ages Inclusion criteria: "Eligible households on the Six Nations Reserve had to be comprised of a male and/or female parent with at least one child living in the same household, and all individuals between 5 and 70 years of age (including grandparents) were eligible." Exclusion criteria: "Households were excluded if they: a) were not willing to have the health counsellor visit their homes, b) had a planned absence from the Reservation for >1 month during the intervention, or c) had a planned break‐up of the household in the coming year. Individual exclusion criteria are listed elsewhere [Reference to a webpage which could not be located]" Recruitment: N/R Weight status at baseline: Body weight was not an inclusion criterion; the mean baseline BMI of the adults participants was 35 in the intervention and 33 in the control group SSB consumption at baseline: Baseline SSB consumption was not an inclusion criterion; baseline SSB and juice consumption was 1.3 servings/day in the intervention and 1.5 servings/day in the control group Equity considerations: "The Six Nations people may be disproportionately affected by obesity because of their rapid change from a physically active to a relatively sedentary lifestyle, as well as their dietary transition from lower energy non‐processed to energy‐dense processed foods, all of which is compounded by the relatively low socio‐economic status of this community" |
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Interventions |
Intervention: Home delivery of water (The intervention included "two 18 L containers of filtered spring water, and 24 bottles of spring water provided to intervention households/week") Behavioural co‐intervention: Dietary counselling (The intervention included "a regular home visit by Aboriginal health counsellors who were trained to assess and set dietary and physical activity goals for each household member") Control: Minimal intervention (Quote: "Usual care families received Canada’s Food Guide to Healthy Eating and Canada’s Physical Activity Guide to Healthy Active Living") |
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Outcomes |
Measures of SSB intake: Servings of SSB ("soda pop and juice") per day, assessed through 1 x 24‐hour dietary recall at baseline and 6 months Measures of intake of alternatives to SSB: Servings of bottled or distilled water per day, assessed through 1 x 24‐hour dietary recall at baseline and 6 months Anthropometric measures: Assessed in the study but not included in our review, due to confounding by non‐beverage‐specific intervention components Adverse outcomes: The study does not report how data on adverse outcomes were collected, and if adverse outcomes were observed or not Other outcomes: None included in this review |
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Context and implementation |
Setting: Participants' homes Sector: Health care Country: Canada Year(s) when implemented: 2005 Mode of implementation: Pilot trial by researchers Level of implementation: Setting‐based intervention |
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Declarations |
COI: No information provided by study authors (the study's primary report does not contain a COI section) Funding: "Canadian Institutes of Health Research (CIHR) Grant number: MCT 64076" Trial registration: N/R Protocol availability: Protocol mentioned in the report but not publicly available |
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Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The study's published report does not provide details on the methods used for randomisation, but the study's statistician provided us with the information that randomisation was performed by a central, automated randomisation service |
Allocation concealment (selection bias) | Low risk | See explanation above |
Similarity of baseline outcome measurements (selection bias) | Low risk | Baseline differences in the outcomes of interest to us (beverages) were small and were taken into account in the analysis |
Similarity of other baseline characteristics (selection and performance bias) | Low risk | Differences in baseline characteristics of household seem to be small (see table 2 of the study's primary report) |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Results are based on a per‐protocol analysis, but attrition was low (< 10%) and similar in the intervention and control group. Quote: "[O]utliers total kcals <200 or >10,000 and those missing baseline or 6‐month data were excluded" |
Blinding (performance and detection bias) Subjective outcomes | High risk | Blinding was not possible, and the outcomes of interest to us were self‐reported |
Contamination (performance bias) | Low risk | Neighbours could have spread the word about the intervention, but it seems unlikely that the control group received the intervention (home delivery of beverages) |
Selective reporting (reporting bias) | Low risk | There was a study protocol (not published), and the outcomes reported correspond with the outcomes in the Methods section, and the Methods section clearly distinguishes primary and secondary outcomes |
Other bias | Low risk | No other concerns |