Results of a pilot sequential multiple assignment randomized trial using counseling to augment a digital weight loss program
Abstract Objective Adaptive interventions may improve the potency and scalability of behavioral weight loss interventions, but the treatments—or treatment combinations—that should be offered are unknown. A two‐stage pilot sequential multiple assignment randomized trial was used to test the timing an...
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| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2024-12-01
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| Series: | Obesity Science & Practice |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/osp4.70018 |
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| Summary: | Abstract Objective Adaptive interventions may improve the potency and scalability of behavioral weight loss interventions, but the treatments—or treatment combinations—that should be offered are unknown. A two‐stage pilot sequential multiple assignment randomized trial was used to test the timing and dose of human support added to a core digital weight loss program. Methods In stage 1, 99 adults with overweight/obesity were randomized at baseline to a kick‐off with or without additional human support. In stage 2, “early non‐responders” who had not achieved a 2% weight loss were re‐randomized after 4 weeks to either biweekly counseling (120 min over 8 weeks) or a one‐time check‐in (30 min) with a dietitian. “Early responders” continued with the mHealth program alone. Feasibility and acceptability were assessed against pre‐specified criteria. Preliminary outcomes (weight loss, self‐monitoring and behavioral goal adherence) were explored. Results The study met all feasibility and acceptability criteria. The rate of early response was 52.5%. Mean (SE) 3‐month percent weight losses were significantly greater in early responders (−6.63% (0.72)) than non‐responders (−1.70% (0.43), p < 0.001). Outcomes were similar by first‐ and second‐line treatment though more counseling (27.3%) than check‐in (12.5%) participants achieved a 5% weight loss. Conclusions Identifying early responders may help optimize weight loss interventions, but more research is needed on rescue treatments for early non‐responders. Trial Registration ClinicalTrial.gov, NCT05929469. |
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| ISSN: | 2055-2238 |