Nollen 2014.
| Study characteristics | ||
| Methods | Study design: RCT Intervention period: 12 weeks Follow‐up period (post‐intervention): nil Differences in baseline characteristics: reported Reliable outcomes: reported Protection against contamination: NR Unit of allocation: individual Unit of analysis: individual |
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| Participants | N (control baseline) = 25 N (control follow‐up) = 23 N (intervention baseline) = 26 N (intervention follow‐up) = 21 Setting (and number by study group): after school, no further details Recruitment: recruited through after‐school programmes located in economically disadvantaged neighbourhoods, girls had to request enrolment packet Geographic region: Kansas City, Missouri, USA Percentage of eligible population enrolled: 46% Mean age: intervention: 11.3 ± 1.5 (9‐14); control: 11.3 ± 1.7 (9‐14) Sex: intervention + control: 100% female |
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| Interventions | Test the feasibility and potential efficacy of a 12‐week stand‐alone mobile technology intervention Intervention was delivered on a MyPal A626 handheld computer (ASUS Computer International, www.asus.com/us/). The device was comparable in size, weight, and appearance to a smart phone and used a Microsoft Windows Mobile 6 operating system. It included goal‐setting and planning that required girls to set 2 daily goals and an accompanying plan for improving the behaviour addressed in each module, cues to action, and self‐monitoring that prompted girls to self‐monitor progress toward their goals at 5 preselected times throughout the day and feedback and reinforcement on goal attainment. Use was reinforced through a song‐based reward system that provided girls one song/day if they responded to 80% of daily prompts. In an attempt to discourage use of the programme beyond the required goal‐setting and self‐monitoring components, the intervention was intentionally designed without gaming, social media, or text messaging formats that could promote rather than diminish screen time. Both conditions lasted 12 weeks and targeted fruits/vegetables (weeks 1‐4); SSBs (weeks 5‐8), and screen time (weeks 9‐12). The mobile intervention prompted real‐time goal setting and self‐monitoring and provided tips, feedback, and positive reinforcement related to the target behaviours. Controls received the same content in a written manual (identical screen shots) but no prompting Diet intervention vs control |
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| Outcomes | Outcome measures
Process evaluation: reported: programme enjoyment |
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| Implementation‐related factors | Theoretical basis: ‘behavioural weight control principles’ Resources for intervention implementation: reported Who delivered the intervention: reported PROGRESS categories assessed at baseline: gender, race/ethnicity, SES (neighbourhood economic disadvantage) PROGRESS categories analysed at outcome: NR Outcomes relating to harms/unintended effects: NR Intervention included strategies to address diversity or disadvantage: NR, but intervention targeted disadvantaged neighbourhoods, and racial and ethnic minority girls Economic evaluation: NR |
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| Notes | Funding: Dr. Nollen was supported by an award that was co‐funded by the Office of Research on Women’s Health (ORWH), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID), and National Institutes of Mental Health (NIMH) (K12 HD052027) and the National Heart Lung and Blood Institute at the NIH (K23 HL090496). The average rating of programme enjoyment was 4.5 (SD 0.9). Favorite parts of the programme were obtaining songs (68.2%) and setting goals (36.4%). The least favourite part of the programme was the reminder prompts (31.8%). Girls used the programme on 63% of days, responded to 42% of prompts, and earned an average of 23.9 songs. Study reports that weight loss was not addressed |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomisation, no other details |
| 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 | 86.2% retention, equally balanced |
| Selective reporting (reporting bias) | Unclear risk | Protocol or trial register not found |
| Other bias | Low risk | No additional threats to validity |