Reach | |
A. Participant exclusion criteria (% excluded) | Based on predefined exclusion criteria, less than 12% of the participants (n = 95) were excluded post screening (Fig. 1). |
B. Percentage who participate | We recruited 649 women into the HeLP-her program or ~10% n of the potential target population. |
C. Participants characteristics versus nonparticipants | The women involved were representative of the broader Australian regional population (income and education). |
D. Qualitative methods | We qualitatively explored program reach (Fig. 2). |
Scoring: “Fully Developed Use” 1. (B) and (C) and at least one other item (A or D) | =Fully Developed Use (A + B + C + D): total of (4/4) |
Efficacy/effectiveness | |
A. Primary outcome measures | At 1-year, the mean weight change in controls was +0.44 kg and in intervention groups was −0.48 kg, a between group difference of −0.92 kg (95% CI −1.67 to −0.16). |
B. Measure of broader outcomes | A broad range of outcomes are described elsewhere (food intake, physical activity, self-efficacy, quality of life) |
C. Robustness across sub-groups | The intervention showed equally efficacy across various age, BMI, income, and education sub-groups. |
D. Attrition (%) | The study retention was 76% at 1 year (Fig. 1). |
E. Qualitative methods | Program effectiveness was explored qualitatively. |
Scoring: Fully Developed Use 1. Has (A), (B), (C), and (D) | =Fully Developed Use (A + B + C + D + E): total of 5/5 “Yes” |
Adoption (setting level) | |
A. Setting exclusions (% or reasons) | Yes, one control town was excluded due to difficultly with participant recruitment. This was because recruitment was conducted during peak farming times “harvesting” (Fig. 1). |
B. Percentage of settings approached that participated | We contacted 311 local stakeholders and 95% (n = 311) agreed to partner with the HeLP-her program, assisting implementation (Table 3). |
C. Characteristics of settings participating versus nonparticipation | Not explored. However, township selection was based on randomization techniques. |
D. Use of qualitative methods | Semi-structured stakeholder interviews were conducted. |
Scoring: “Fully Developed Use”—adoption setting 1. Must have (B) and (C) and at least one other item (A or D) | =Partially Developed (A + B + D + E): total score of 4/5 |
Adoption-staff level—not applicable | |
Scoring: “Fully Developed Use”—adoption-researchers | N/A |
Implementation | |
A. Percentage of full delivery or full calls | Comprehensive process evaluation results revealed strong implementation fidelity and high dose delivered. |
A. Program adaptions | Implementation was standardized across communities as per study protocol with minor adaptations reported previously. |
B. Cost of intervention | Comprehensive economic evaluation is underway. |
C. Consistency of researchers, time, and setting | Comprehensive process evaluation indicated implementation consistency. |
D. Qualitative methods applied | Program implementation was explored at the community and organizational level with high program acceptability |
Scoring: “Fully Developed Use”—implementation: 1. Have (A), (C), and (D) plus at least one more item (B or E) | Fully Developed Use = (A + B + C + D + E): total of 5/5 |
Maintenance—individual | |
A. Primary outcome after final intervention | As above, anthropometric data was collected at baseline and 12 and 24 months with results pending. |
B. Measure of broader outcomes, multiple criteria at follow-up | Data analysis collected at 0 and 12 months with food intake, physical activity, self-efficacy and self-management. These outcomes measures will be again explored at 24 months. |
C. Robustness data—sub-group effects over the long term | 24-month data analysis planned with results pending. |
D. Attrition (%) | 24-month data analysis planned with results pending. |
Scoring: “Fully Developed Use”—maintenance—individual: has (A), (B), (C), and (D) | Fully Developed Use = (A) + (B) + (C) + (D): total of 4/4 |
Maintenance—setting | |
A. Program continuation 6 months post study completion | The HeLP-her program has been endorsed by the Victoria local government preventative health taskforce |
B. How program was adapted | N/A |
C. Discussion of alignment to organization mission | Exploration undertaken with stakeholders, highlighting that prevention orientated program aligns with local organizational values. |
D. Use of qualitative methods. | Stakeholder interviews conducted exploring potential for program continuation and “scale-up”. |
Scoring: “fully developed use”—maintenance-setting 1. Has (A) and at least 1 more item (B, C, or D) | Fully Developed Use = (A) + (C) + (D) = 3/3 |
Entire RE-AIM model scoring | |
Reach | Fully Developed Use = (A + B + C + D): total of 4/4 “Yes” |
Effectiveness | Fully Developed Use = (A + B + C + D + E): total of 5/5 “Yes” |
Adoption | Partial Developed (A + B + D + E): total of 4/5 “Yes” |
Implementation | Fully Developed Use = (A + B + C + D + E): total of 5/5 “Yes” |
Maintenance: individual | Fully Developed Use = (A) + (B) + (C) + (D): total of 4/4 “Yes” |
Maintenance: setting: | Fully Developed Use = (A) + (C) + (D): total of 3/3 “Yes” |
Total score: 25/26 = 96% across all RE-AIM dimensions |