Ostbye 2012.
Study characteristics | ||
Methods | Study name: KAN‐DO (Kids and adults now — defeat obesity!) Study design: RCT Intervention period: 8 months Follow‐up period (post‐intervention): 12 months Differences in baseline characteristics: reported Reliable outcomes: reported Protection against contamination: NR Unit of allocation: mother and child dyads Unit of analysis: individual |
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Participants | N (control baseline) = 200 N (control follow‐up) = 151 (child’s weight) N (intervention baseline) = 200 N (intervention follow‐up) = 150 (child’s weight) Setting (and number by study group): home setting with one group session Recruitment: postpartum women who were overweight/obese prior to pregnancy and their children aged 2–5 years, women were primarily identified from state birth certificates and screened for eligibility at 2–6 months postpartum Geographic region: Triangle and Triad regions of North Carolina, USA Percentage of eligible population enrolled: 28% (496/1769) Mean age: intervention + control: 3.06 ± 1.0 Sex: intervention: 43.5% female; control: 45.0% female |
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Interventions | To enhance healthy lifestyle behaviours in mother–preschooler (2–5 years old) dyads in North Carolina Participants in the intervention arm received 8 monthly mailed interactive kits, followed each month by a 20–30‐min telephone coaching session using MI techniques. Kits included child activities and incentives reinforcing the month's topic (e.g. a rewards chart, yoga mat, pedometer, portion plate). The intervention targeted the dyad's healthy weight via instruction in parenting styles and skills, techniques for stress management (including emotion regulation), and education about healthy behaviours. Parenting skill instruction emphasised
Education about healthy behaviour changes in the dyad targeted:
Coaching calls reviewed information in the module and addressed motivation, self‐efficacy, and barriers to change. The intervention also included one semi‐structured group session, where the study coaches and nutritionist reinforced content from the family kits and set aside time for role play and group discussion. A healthy meal and free child care were provided. Control arm participants received monthly newsletters emphasizing pre‐reading skills PA combination intervention vs control |
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Outcomes | Outcome measures
Process evaluation: NR |
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Implementation‐related factors | Theoretical basis: SCT Resources for intervention implementation: reported Who delivered the intervention: reported PROGRESS categories assessed at baseline: gender; parent: race/ethnicity, SES (household income), education, marital status PROGRESS categories analysed at outcome: NR Outcomes relating to harms/unintended effects: NR Intervention included strategies to address diversity or disadvantage: NR (except that intervention targeted overweight mothers) Economic evaluation: NR |
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Notes |
NCT00563264 Funding: this study was funded by a grant from the NIH, National Institute of Diabetes, Digestive and Kidney Diseases (R01‐DK‐07549). Dr. Zucker was supported by grant 1‐K23‐MH‐070‐418‐01. Run‐in period prior to randomisation All participants received monetary incentives (totaling USD 100) to complete assessments. Study is ongoing – this paper only reports 8‐month outcomes (22‐month outcomes to follow) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated, with permuted 8‐block randomisation |
Allocation concealment (selection bias) | Unclear risk | NR |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | NR |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 23% attrition, balanced across groups |
Selective reporting (reporting bias) | Low risk | All outcomes specified were reported; protocol paper reports that outcomes will be reported at 10 months post‐baseline but the available outcome paper reports at 8 months |
Other bias | Low risk | No additional threats to validity |